AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

2.2.9. Microbial Contamination in Nonsterile Insert at the end

Products. Page 40 “(Applicable for Modified-release dosage forms also)”

Enumeration of aerobic microorganisms present in the

product 4.2 General Reagents
Pour-plate method. Line 13 Insert before D-Galactose. Page. 1093
Change from : 25 colonies for fungi. Gastric Juice, Artificial (without enzyme). Dissolve 2.0 g
of sodium chloride in water, add 80 ml of 1M hydrochloric
to : 50 colonies for total fungal count.
acid and dilute to 1000 ml with water.
Insert before Perchloric Acid x M. Page 1108
2.4.1. Appearance of Solution. Page 211
Perchloric Acid Solution. Dilute 8.5 ml of perchloric acid
Clarity of Solution to 100.0 ml with water.
Method. Line 4 and 5 1,10-Phenanthroline. Page 1109
Change from : Into another matched test-tube add the same Change to: Phenanthroline Hydrochloride; 1,10-Phenanthroline
volume of the freshly prepared opalescence standard. Hydrochloride Monohydrate: C12H9ClN2,H2O = 234.7
to : Into another matched test-tube add the same Analytical reagent grade of commerce.
volume of water or the solvent used for preparing the
solution being examined or the freshly prepared opalescence A white or almost white crystalline powder; mp. about 215º
standard. with decomposition.
Phenanthroline Solution. Delete the requirement.
2.4.14. Liquid Chromatography. Page 235 Page 1131
System suitability, para 4, line 3 Insert before Tris Buffered Saline (TBS)
Change from: the symmetry factor is 0.8 to 1.5, Tris Buffer xM. Dissolve 121.14 g of tris in water and dilute
to 1000 ml with water.
to : the symmetry factor is 0.8 to 1.8,

2.4.22. Optical Rotation and Specific Optical 4.3. Indicators and Indicator Test Papers
Rotation. Page 257 Ferroin Solution. Page 1137
Method. For liquids, line 2 Change to: Ferroin Solution; Ferroin Sulphate Solution;
Change from: 25º Ferroin: Dissolve 0.7 g of ferrous sulphate and 1.76 g of
phenanthroline hydrochloride in 70 ml of water and dilute to
to : 25º ± 0.5º 100 ml with same solvent.
Complies the following test.
2.4.26. Solubility. Page 264
SENSITIVITY — To 50 ml of dilute sulphuric acid, add
Insert before Galantamine Hydrobromide 0.1 ml of ferroin solution. After the addition of 0.1 ml of
Gabapentin. Sparingly soluble in water, slightly soluble in 0.1 M ceric ammonium nitrate the colour changes from red
ethanol (95 per cent), practically insoluble in to light blue.
dichloromethane. It dissolves in dilute acids and dilute
solutions of alkali hydroxides.
4.5. Volumetric Reagents and Solutions
Primary Standards. Page 1144
2.5.2. Dissolution Test. Page 354
Insert before Potassium Bromate
Methods.
Ferrous Ethylenediammonium Sulphate: Ethylenedi-
For Apparatus 1 and Apparatus 2 ammonium iron(II) disulphate tetrahydrate; Ethylenedi-
Conventional and prolonged-release solid dosage forms. ammonium tetra aquabis(sulphato)iron(II); Fe(C2H10N2)
Para 1 (SO4)2,4H2O = 382.1.

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AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

Page 1145 Aluminium, Magnesium and

Insert before Cupric Sulphate, 0.02M Simethicone Chewable Tablets. Page 1412
Cerium Sulphate, 0.1M: Dissolve 40.4 g of cerium sulphate
Identification. A
in a mixture of 500 ml of water and 50 ml of sulphuric acid.
Allow to cool and dilute to 1000.0 ml with water. Standardise Change from: Determine by infrared absorption
the solution in following manner. spectrophotometry (2.4.6). Compare the spectrum with that
obtained with polydimethylsiloxane IPRS or with the
Dissolve 0.300 g of ferrous ethylenediammonium sulphate
reference spectrum of polydimethylsiloxane.
in 50 ml of 0.5M sulphuric acid and titrate with 0.1 M cerium
sulphate, determine the end-point potentiometrically (2.4.25) to : Determine by infrared absorption
or using 0.1 ml of ferroin solution as indicator. spectrophotometry (2.4.6), using the test solution prepared
in the Assay of polydimethylsiloxane. Compare the spectrum
1 ml of 0.1 M cerium sulphate is equivalent to 38.21 mg of with that obtained with the reference solution in the Assay of
Fe(C2H10N2)(SO4)2,4H2O. polydimethylsiloxane.

Capsules. Page 1297 (Effective from 12/07/2023) Amiodarone Tablets. Page 1440
Soft Gelatin Capsules Identification
Disintegration. Line 5 A. Para 2, line 4
Change from: amiodarone hydrochloride
Change from : 60 minutes
to : amiodarone
to : 30 minutes
NOTE — This change shall not be applicable for capsules
containing any three or more components of vitamins, Amlodipine and Atenolol Tablets. Page
minerals, amino acids, fatty acids, trace elements etc. for 1448
which amendment will be issued by IPC in forthcoming IP
Related substances.
Addendum 2024.
Test solution. Line 2
Change from: 100 mg of Atenolol
to : 10 mg of Amlodipine
Adrenaline Tartrate. Page 1388
Assay.
Identification. C, line 1
Test solution, line 2
Change from : reaction (C)
Change from: 50 mg of Atenolol
to : reaction (B) to : 10 mg of Amlodipine

Aluminium, Magnesium and Aspirin Tablets. Page 1516

Simethicone Oral Suspension. Page 1410 Dissolution. Para 2, line 4
Change from: maximum
Identification. A
to : isosbestic point of aspirin and salicylic acid
Change from: Determine by infrared absorption
spectrophotometry (2.4.6). Compare the spectrum with that
obtained with polydimethylsiloxane IPRS or with the Aspirin Gastro-resistant Tablets. Page 1518
reference spectrum of polydimethylsiloxane.
to : Determine by infrared absorption Identification
spectrophotometry (2.4.6), using the test solution prepared Change to: Disperse a quantity of powdered tablets
in the Assay of polydimethylsiloxane. Compare the spectrum containing 0.5 g of Aspirin with 20 ml of ethanol and filter.
with that obtained with the reference solution in the Assay of Evaporate the filtrate and dry the residue at 60º for 1 hour.
polydimethylsiloxane. The residues comply with the following test.

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AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

Determine by infrared absorption spectrophotometry (2.4.6). Atropine Sulphate. Page 1545

Compare the spectrum with that obtained with aspirin IPRS
or with the reference spectrum of aspirin. Specific optical rotation. Line 1
Change from: Specific optical rotation
Dissolution.
to : Optical rotation
A. Line 7
Change from : maximum
to : isosbestic point of aspirin and salicylic acid Barium Sulphate Oral Suspension. Page
1579
B. Line 7
Microbial contamination. Line 4
Change from: maximum
to : isosbestic point of aspirin and salicylic acid Insert before Staphylococcus aureus

Salicylic acid. “Escherichia coli,”

Insert before Test solution

NOTE — Prepare the solutions immediately before use. Compound Benzoic Acid Ointment. Page
Assay. 1600
Insert before Test solution Para 1, last line
NOTE — Prepare the solutions immediately before use. Change from: the ratio of about 2 to 1.
to : the ratio of 2 to 1.
Para 2
Aspirin Gastro-resistant and Change to: Compound Benzoic Acid Ointment contains not
Atorvastatin Capsules. Page 1519 less than 95.0 per cent and not more than 105.0 per cent of
benzoic acid, C7H6O2, and salicylic acid, C7H6O3.
Related substances.
For Aspirin —
Insert before Test solution Betaxolol Hydrochloride. Page 1631
NOTE — Prepare the solutions immediately before use. Assay. Change to:
Assay. Dissolve 0.3 g in 10.0 ml of 0.01 M hydrochloric
acid and add 50 ml of ethanol (95 per cent). Titrate with
Aspirin Gastro-resistant and 0.1 M sodium hydroxide, determining the end-point
potentiometrically (2.4.25). Read the volume added between
Rosuvastatin Capsules. Page 1522 the 2 points of inflexion.
Related substances. 1 ml of 0.1 M sodium hydroxide is equivalent to 0.03439 g of
For Aspirin — C18H30ClNO3.
Insert before Test solution
NOTE — Prepare the solutions immediately before use.
Bicalutamide. Page 1636
Assay.
Assay. Test solution, line 2, 3 and 4
For Aspirin —
Change from: mobile phase
Insert before Test solution
to : solvent mixture
NOTE — Prepare the solutions immediately before use.
Reference solution. Line 2
Change from: mobile phase
Atropine Methonitrate. Page 1544 to : solvent mixture

Specific optical rotation. Line 1

Change from: Specific optical rotation Cefoperazone Sodium. Page 1785
to : Optical rotation Acetone. Delete the requirement.

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AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

Ceftriaxone and Sulbactam for Chlorpromazine Tablets. Page 1860

Injection. Page 1802 Identification. B, line 8
Assay. Chromatographic system, insert after line 2 Change from: maxima at about 254 nm and 306 nm; 0.45 to
– sample temperature: 10º, 0.48 (2.4.7).
to : maxima at about 254 nm and 306 nm;
absorbance at about 254 nm, 0.45 to 0.48 (2.4.7).
Chlorcyclizine Hydrochloride. Page 1838
Assay. Change to:
Dextropropoxyphene Capsules. Page 2066
Assay. Weigh accurately about 0.2 g, dissolve in 1 ml of 0.1
M hydrochloric acid and add 50 ml of methanol. Titrate with Identification. A, line 4
0.1M sodium hydroxide, determining the end-point Change from: dextropropoxyphene napsilate IPRS
potentiometrically (2.4.25). Read the volume added between
to : dextropropoxyphene hydrochloride IPRS
the 2 points of inflexion.
Line 5
1 ml of 0.1 M sodium hydroxide is equivalent to 0.03373 g of
C18H21ClN2,HCl. Change from: dextropropoxyphene napsilate.
to : dextropropoxyphene hydrochloride.
C. Delete the requirement.

Chloroquine Phosphate Suspension. Page

1849
Assay. Dithranol. Page 2142
Insert at the end Dihydroxyanthracene. Delete the requirement.

Determine the weight per ml (2.4.29) of the suspension and Dihydroxyanthraquinone. Delete the requirement.
calculate the content of C18H26ClN3 weight in volume.
Storage. Store protected from light.
Labelling. The label states the strength in terms of the
Ephedrine Nasal Drops. Page 2243
equivalent amount of chloroquine. Identification
B. Line 3
Change from: peak
Chlorpromazine Hydrochloride. Page 1859 to : spot
Identification. B, lines 3 and 4 Assay.
Change from: absorption maxima at about 254 nm and 306 Insert after Chromatographic system
nm; 0.45 to 0.48 (2.4.7).
Inject the reference solution. The test not valid unless the
to : absorption maxima at about 254 nm and 306 column efficiency is not less than 2000 theoretical plates, the
nm; absorbance at about 254 nm, 0.45 to 0.48 (2.4.7). tailing factor is not more than 2.0, and the relative standard
deviation for replicate injections is not more than 2.0 per
cent.

Chlorpromazine Injection. Page 1860

Identification. B, lines 5 and 6 Ephedrine Oral Solution. Page 2244
Change from: ...absorption maxima at about 254 nm and
306 nm; 0.45 to 0.48 (2.4.7).
Identification
to : ...absorption maxima at about 254 nm and Change from: peak
306 nm; absorbance at about 254 nm, 0.45 to 0.48 (2.4.7). to : spot

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AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

Assay. Glycerin. Page 2485

Insert after Chromatographic system Ethylene glycol, diethylene glycol and related substances.
Inject the reference solution. The test not valid unless the Test solution. Line 1
column efficiency is not less than 2000 theoretical plates, the
Change from: 5.88 g
tailing factor is not more than 2.0, and the relative standard
deviation for replicate injections is not more than 2.0 per to : 5 g
cent. Reference solution (a). Line 4
Change from: 5.88 g
to : 5 g
Ethylcellulose. Page 2299
Apparent viscosity. Change to:
Granisetron Injection. Page 2499
Apparent viscosity. 80.0 to 120.0 per cent of that stated on
Related substances. Last para, line 2
the label for viscosity types of more than 6 mPa s; 75.0 to
140.0 per cent of that stated on the label for viscosity types Change from: twice
of not more than 6 mPa s, determined by the following to : 3 times
method.
Weigh accurately 5.0 g of dried substance under examination
and dissolve in 95 g of a mixture of 80 g of toluene and
20 g of ethanol (95 per cent). Determine the viscosity at 25° Labetalol Hydrochloride. Page 2681
by Method A (2.4.28). Diasterioisomer ratio. Chromatographic system, line 2 and
3
Delete “(Such as DB-17)”
Felodipine. Page 2338
Assay. Line 2
Change from: 1M perchloric acid. Levamisole Hydrochloride. Page 2727
to : perchloric acid solution. Assay. Change to:
Assay. Dissolve 0.2 g in 30 ml of ethanol (95 per cent), add
5.0 ml of 0.01 M hydrochloric acid. Titrate with 0.1 M
Fusidic Acid. Page 2439 sodium hydroxide, determining the end-point
potentiometrically (2.4.25). Read the volume added between
Identification. B, the 2 points of inflection.
Reference solution. Change to: 1 ml of 0.1 M sodium hydroxide is equivalent to 0.02408 g of
Reference solution. A 0.2 per cent w/v solution of fusidic C11H12N2S,HCl.
acid IPRS in ethanol (95 per cent).

Levetiracetam. Page 2729

Fusidic Acid Cream. Page 2440 Levetiracetam impurity B. Reference solution (a), line 2
Change from: levetiracetam impurity B IPRS
Identification. A
to : levetiracetam impurity B IPRS ((S)-2-
Reference solution (a). Change to: aminobutanamide hydrochloride)
Reference solution (a). A 0.5 per cent w/v solution of fusidic
acid IPRS in ethanol (95 per cent).
Assay. Lignocaine. Page 2757
Reference solution. Change to: Identification. B, line 3
Reference solution. A 0.03 per cent w/v solution of fusidic Change from: the reference solution.
acid IPRS in the mobile phase. to : reference solution (a).

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AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

Assay. After chromatographic system, para1 Mometasone Aqueous Nasal Spray. Page
Change to: Inject reference solution (a) and (c). The test is 2956
not valid unless the resolution between the peaks due to Insert before Assay
lignocaine and methylparaben is not less than 3.0 in the
chromatogram obtained with reference solution (c) and the Other tests. Comply with the tests stated under Nasal
relative standard deviation for replicate injections is not Preparations.
more than 1.5 per cent in the chromatogram obtained with
reference solution (a).
Para 2
Montelukast Sodium. Page 2959
Change from: Inject reference solution (b) and the test
solution. Related substances.
to : Inject reference solution (a) and the test Insert before Chromatographic system
solution.
Reference solution (c). A solution containing 0.1 per cent
w/v of montelukast sodium IPRS, 0.0003 per cent w/v, each
of, montelukast sulphoxide IPRS and montelukast styrene
IPRS in the solvent mixture.
Mebeverine Hydrochloride. Page 2829
After chromatographic system, para 1
Identification. C, line 2
Change to:
Change from: reactions
to : reaction A Name Relative
retention time
Montelukast sulphoxide isomer 0.66 and 0.69
Montelukast 1.0
Mefenamic Acid and Dicyclomine Montelukast styrene 1.38
Hydrochloride Tablets. Page 2839
Inject reference solution (c) to identify the peaks due to
Dissolution. For Mefenamic acid — montelukast sulphoxide and montelukast styrene.
Test solution. Change to:
Test solution. Dilute a suitable volume of the filtrate with the
dissolution medium to obtain a solution having expected
concentration similar to the reference solution.
Montelukast Granules. Page 2960
For Dicyclomine hydrochloride — Dissolution. After chromatographic system, line 4 and 5,

Test solution. Change to: Delete the following requirement

Test solution. Dilute a suitable volume of the filtrate with the ‘1 mg of C47H59ClN2O3S is equivalent to 0.7637 mg of
mobile phase to obtain a solution having expected C35H36ClNO3S.’
concentration similar to the reference solution. Uniformity of content. Last line
Delete the following requirement
‘1 mg of C47H59ClN2O3S is equivalent to 0.7637 mg of
Microcrystalline Cellulose. Page 2937 C35H36ClNO3S.’
Insert before Assay Assay. Last line
Microbial contamination (2.2.9). The total aerobic viable Delete the following requirement
count is not more than 1000 cfu per g and total fungal count
‘1 mg of C47H59ClN2O3S is equivalent to 0.7637 mg of
is not more than 100 cfu per g. 1 g is free from Escherichia
C35H36ClNO3S.’
coli, Staphylococcus aureus and Pseudomonas aeruginosa
and 10 g is free from Salmonella and Shigella.

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AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

Montelukast Tablets. Page 2962 Montelukast and Levocetirizine Tablets.

Page 2963
Related substances.
Assay. Test solution, line 2
Reference solution (a). Change to:
Change from: Montelukast Sodium
Reference solution (a). Dissolve a suitable quantity of
to : montelukast
montelukast sodium IPRS in the solvent mixture and dilute
with the same solvent to obtain a solution containing 0.0025 Reference solution (a). Change to:
per cent w/v of montelukast. Reference solution (a). A solution of montelukast sodium
Insert before Chromatographic system IPRS containing 0.25 per cent w/v of montelukast in the
solvent mixture.
Reference solution (c). A solution containing 0.5 per cent
w/v of montelukast sodium IPRS, 0.0025 per cent w/v of
montelukast sulphoxide IPRS and 0.005 per cent w/v of
montelukast styrene IPRS in a mixture of 80 volumes of Naloxone Hydrochloride. Page 3020
methanol and 20 volumes of water. Dilute 1.0 ml of the
solution to 10.0 ml with the solvent mixture. Related substances. Last para, line 4

After chromatographic system. Para 1 and 2 Change from : A, B, C, E, F multiplied with correction factor
0.5
Change to
to : A, B, C, E, F
Name Relative
retention time
Montelukast sulphoxide isomer 0.64 and 0.66
Nystatin Pessaries. Page 3095
Montelukast 1.0
Montelukast styrene 1.37 Identification
Inject reference solution (c) to identify the peaks due to Change to: Identification
montelukast sulphoxide and montelukast styrene. Para 2- Delete the requirement
Inject reference solution (b). The test is not valid unless the
relative standard deviation for replicate injections is not
more than 5.0 per cent.
Ornidazole Injection. Page 3131
Inject reference solution (b) and the test solution. In the
chromatogram obtained with the test solution, the sum of Appearance of solution. Change to:
areas of the peaks due to montelukast sulphoxide isomers is Appearance of solution. The solution is clear (2.4.1) and
not more than twice the area of the principal peak in the not more than intensely coloured than YS5 (2.4.1).
chromatogram obtained with reference solution (b) (1.0 per
cent), the area of any peak corresponding to montelukast
styrene is not more than the area of the principal peak in the
chromatogram obtained with reference solution (b) (0.5 per Orphenadrine Citrate. Page 3133
cent), the area of any other secondary peak is not more than
the area of the principal peak in the chromatogram obtained
Identification. A
with reference solution (b) (0.5 per cent) and the sum of Insert at the end
areas of all the secondary peaks is not more than 4 times the “or with the reference spectrum of orphenadrine citrate.”
area of the principal peak in the chromatogram obtained
with reference solution (b) (2.0 per cent). Ignore any peak
with an area less than 0.1 times the area of the principal peak
in the chromatogram obtained with reference solution (b) Oseltamivir Oral Suspension. Page 3138
(0.05 per cent).
Insert after para 3
When stored at the temperature and for the period stated on
the label during which the constituted suspension may be

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AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

expected to be satisfactory for use, it contains not less than to : Tests A and C may be omitted if tests B and D
80.0 per cent of the stated amount of oseltamivir, C16H28N2O4. are carried out. Tests B and D may be omitted if tests A and
Assay. Last line C are carried out.
Change from: Calculate the content of C16H28N2O4.
to : Determine the weight per ml of the suspension
(2.4.29) and calculate the content of C16H28N2O4, weight in Pyrantel Pamoate Oral Suspension. Page
volume. 3398
Identification. A. Line 2
Change from: silica gel H.
Paracetamol Infusion. Page 3194 to : silica gel GF 254.
Related substances. Last para, lines 1 to 6 Assay. Test solution. Line 2
Change to: Inject reference solution (a), (b), (c) and the test Change from: 60 mg
solution. Run the chromatogram 12 times the retention time to : 70 mg
of the principal peak. The area of any peak corresponding to
4-aminophenol is not more than 0.5 times the area of the
corresponding peak in the chromatogram obtained with
reference solution (b) (0.1 per cent). Pyridostigmine Tablets. Page 3401
Assay. Reference solution, line 1

Phenylephrine Injection. Page 3257 Change from: 0.25 per cent

Bacterial endotoxins. Line 2 to : 0.025 per cent

Change from : phenylephrine.

to : phenylephrine hydrochloride.
Rabeprazole Gastro-resistant Tablets.
Page 3441
Piperacillin and Tazobactam Injection. Dissolution. Change to:
Page 3286
Dissolution (2.5.2).
Related substances. Reference solution (d). Change to:
A. Apparatus No. 2 (Paddle),
Reference solution (d). Dilute reference solution (a) and (b) Medium. 700 ml of 0.1 M hydrochloric acid,
with the mobile phase to obtain a solution containing 0.0025 Speed and time. 100 rpm and 2 hours.
per cent w/v of tazobactam and 0.02 per cent w/v of
piperacillin. Determine by liquid chromatography (2.4.14).
Solvent mixture. 80 volumes of methanol, 20 volumes of
water and 0.1 volume of diethylamine.
Polyethylene Glycol 4000. Page 3303 Test solution. Withdraw the medium completely and disperse
Viscosity. Line 1 the intact tablet in 0.1M sodium hydroxide (20 volume of the
total volume), with the aid of ultrasound and dilute to volume
Change from: determined at 100º with the solvent mixture to obtain a solution containing
to : determined between 98.6º to 99.2º 0.02 per cent w/v of Rabeprazole Sodium and filter.
Reference solution. Dissolve 20 mg of rabeprazole sodium
IPRS in 20 ml of 0.1M sodium hydroxide and dilute to
Prednisone. Page 3340 100.0 ml with the solvent mixture.

Identification Use chromatographic system as described under Assay.

Inject the reference solution and the test solution.
Change from: Tests A and B may be omitted if tests C and D
are carried out. Tests C and D may be omitted if tests A and Calculate the content of C18H20N3O3S,Na released in the acid
B are carried out. medium by subtracting the content of C18H20N3O3S,Na in the

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AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

test solution from the total content of Rabeprazole Sodium column efficiency is not less than 2000 theoretical plates, the
C18H20N3O3S,Na determined in the Assay. tailing factor is not more than 2.0 and the relative standard
Complies with the acceptance criteria given under acid deviation for replicate injections is not more than 5.0 per
stage. cent in the chromatogram obtained with reference solution
(b).
B. Apparatus No. 2 (Paddle),
Medium. 900 ml of a mixture containing 70 volumes of 0.1 Last para, line 2
M hydrochloric acid and 30 volumes of 0.6 M tris buffer, Change from : three times
adjusted to pH 8.0 with 2 M hydrochloric acid or 2 M sodium
to : four times
hydroxide,
Speed and time. 100 rpm and 45 minutes.
Transfer another 6 tablets and run the apparatus for 2 hours
in 0.1 M hydrochloric acid. Decant the medium without Silver Sulphadiazine. Page 3581
losing the tablets, add dissolution medium and run the
apparatus for 45 minutes. Withdraw a suitable volume of the Related substances. Last para, line 9
medium and filter.Determine by liquid chromatography Change from: and the sum of areas of all peak
(2.4.14). to : , the area of any other secondary peak
Test solution. Dilute the filtrate, if necessary, with the
dissolution medium. To 5.0 ml of the solution, add
immediately 1.0 ml of 0.1M sodium hydroxide
Reference solution. A 0.055 per cent w/v solution of Sisomicin Sulphate. Page 3586
rabeprazole sodium IPRS in 0.1M sodium hydroxide. Dilute
2.0 ml of the solution to 100.0 ml with the dissolution Identification. A, Reference solution (a)
medium. To 5.0 ml of the solution, add immediately 1.0 ml Change from: sisomicin IPRS
of 0.1M sodium hydroxide. to : sisomicin sulphate IPRS
Use chromatographic system as described under Assay.
Inject the reference solution and the test solution.
Calculate the content of C18H20N3O3S,Na in the medium.
Q. Not less than 70 per cent of the stated amount of
Sisomicin Sulphate Injection. Page 3586
C18H20N3O3S,Na. Identification. Reference solution (a)
Related substances. Change from: sisomicin IPRS
Insert after Para 5 to : sisomicin sulphate IPRS
Reference solution (c). Dissolve 2.5 mg, each of, rabeprazole
sulphide IPRS and rabeprazole sulphone IPRS in 2.5 ml
methanol and dilute to 50.0 ml with the solvent mixture.
Reference solution (d). Dissolve 25 mg of rabeprazole Sodium Aminosalicylate Tablets. Page 3595
sodium IPRS in 30 ml of water, add 5.0 ml of reference 3-aminophenol. Reference solution (a). Change to:
solution (c) and dilute to 50.0 ml with the solvent mixture.
Reference solution (a). A 0.025 per cent w/v solution of
Para 7
m-aminophenol IPRS in the mobile phase. Dilute 1.0 ml of
Change from : Inject reference solution (a). The test is not the solution to 50.0 ml with the mobile phase.
valid unless the column efficiency is not less than 2000
theoretical plates and the tailing factor is not more than 2.0.
to: Inject reference solution (d) to identify the
peaks due to rabeprazole sulphide and rabeprazole sulphone. Monobasic Sodium Phosphate. Page 3622
Inject reference solution (b) and (d). The test is not valid
Line 1
unless the resolution between the peaks due to rabeprazole
sodium and rabeprazole sulphone is not less than 1.5 in the Change to: Sodium Dihydrogen Phosphate; Sodium
chromatogram obtained with reference solution (d), the Acid Phosphate

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AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

Sodium Starch Glycolate (Type A). Page Name Relative Correction

3625 retention time factor
Para 2, line 3 Fluoro uridine phosphate
impurity1 0.21 0.93
Change from: Ethanol (95 per cent)
Fluoro uridine impurity2 0.39 0.5
to : Ethanol (80 per cent)
Uridine alanine phosphate
Iron. Change to: impurity3 0.45 1.61
Iron (2.3.14). 10.0 ml of solution A complies with the limit Uridine phenyl phosphate
test for iron (20 ppm), using 1.0 ml of iron standard solution impurity4 0.61 1.11
(10 ppm). Uridine isopropyl alanine
Sodium glycolate. Reference solution, line 6 and 7 phosphate impurity5 0.65 0.9
Delete the following Phenol impurity6 0.72 2.17
“Add 50 ml of acetic acid and allow to stand for 30 minutes.” Ethyl analog7* 0.93 ---
Sofosbuvir Rp isomer8* 0.98 ---
Assay
Sofosbuvir (Retention time:
Line 3 and 4 about 16.5 minutes) 1.0 ---
Change from: silver nitrate solution. Chloro analog impurity9* 1.05 ---
to: dilute silver nitrate solution. Penta fluoro phenyl impurity10* 1.13 ---
Phosphoramidate sofosbuvir
impurity11* 1.41 ---
Sodium Starch Glycolate (Type B). Page Phosphoramidate intermediate
3626 impurity12* 1.57 ---
Iron. Change to: *
Process impurity include for identification only and not included in the
calculation of total degradation products.
Iron (2.3.14). 10.0 ml of solution A complies with the limit 1
2’-deoxy-2’-fluoro-2’-methyluridine 5’-(dihydrogen phosphate),
test for iron (20 ppm), using 1.0 ml of iron standard solution 2
2’ -deoxy-2’ -fluoro-2’ -methyluridine,
(10 ppm). 3
(2S)-2{[{[(2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-
Assay fluoro-3-hydroxy-4-methyltetrahydrofuran-2yl]methoxy}(hydroxy)
phosphoryl]amino}propanoic acid,
Line 3 and 4 4
2’-deoxy-2’-fluoro-5-O-[hydroxyl(phenoxy)phosphoryl]-2’-methyl-
Change from : silver nitrate solution. uridine,
to : dilute silver nitrate solution.
5
propan-2-yl(2S)-2-{[{[(2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydro-
pyrimidin-1(2H)-yl)-4-fluro-3hydroxy-4-methyltetrahydrofuran-2-yl]
methoxy}(hydroxy)phosphoyl]amino}propanoate,
6
phenol or hydroxy benzene,
Sodium Valproate Gastro-resistant 7
(S)-2-[(S)-[[(2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-
4-fluoro-3-hydroxy-4-methyltetrahydro-2-furanyl] methoxy] (phenoxy)
Tablets. Page 3634 phosphorylamino]propanoic acid-1-ethyl ester,

Related substances. Last para, line 5 and 6

8
propan-2-yl-(2S)-2-{[(R)-{[(2R,3R,4R,5R)-5-(2,4-dioxo-3,4-
dihydropyrimidin-1-(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetra-
Change from : and the sum of areas of all peak hydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino} propanoate,
9
propan-2-yl-(2S)-2-{[(S)-{[(2R,3R,4R,5R)-4-chloro-5-(2,4-dioxo-3,4-
to : , the area of any other secondary peak
dihydropyrimidin-1-(2H)-yl)-3-hydroxy-4-methyltetrahydrofuran-2-yl]
methoxy}(phenoxy)phosphoryl]amino} propanoate ,
10
2,3,4,5,6-pentafluoro phenol,

Sofosbuvir Tablets. Page 3637 propan-2-yl

11
(2S)-2-{[(R)-{[(2R,3R,4R,5R)-2-[(3S,5S)-5,8-dimethyl-3-
oxido-6-oxo-3-phenoxy-2,7-dioxa-4-aza-315-phosphanon-1-yl]-5-(2,4-
Related substances. After chromatographic system, dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-4-methyltetrahydrofuran-
3-yl]oxy}(phenoxy)phosphoryl]amino}propanoate,
impurity table
N-[(S)-(2,3,4,5,6-pentafluoro
12
phenoxy) phenoxyphos-phinyl]-L-
Change to: Alanine-1- methyl ethyl ester.

10
AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

Last para, line 8 and 9 Change to:

Change from: sum of areas of all peak Name Relative Correction
to : area of any other secondary peak retention time factor
Assay. Fluoro uridine impurity1 0.14 0.49
Reference solution. Change to: Ethyl analog impurity 2*
0.91 ---
Reference solution. A 0.048 per cent w/v solution of Sofosbuvir Rp isomer3* 0.97 ---
sofosbuvir IPRS in the solvent mixture. Sofosbuvir 1.0 ---
Chloro analog impurity4* 1.06 ---
Penta fluoro phenyl impurity5* 1.09 ---
Phosphoramidate sofosbuvir
Sofosbuvir and Daclatasvir Tablets. Page impurity6* 1.53 ---
3639
Phosphoramidate intermediate
Related substances. For Daclatasvir — impurity7* 1.73 ---
After chromatographic system, impurity table *
Process impurity include for identification only and not included in the
calculation of total degradation products.
Change to: 1
2’ -deoxy-2’ -fluoro-2’ -methyluridine,
Name Relative 2
(S)-2-[(S)-[[(2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-
retention time 4-fluoro-3-hydroxy-4-methyltetrahydro-2-furanyl] methoxy](phenoxy)
phosphorylamino]propanoic acid-1-ethyl ester,
Coupled amine hydrochloride impurity1* 0.49 3
propan-2-yl-(2S)-2-{[(R)-{[(2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydro-
Mono impurity 2*
0.85 pyrimidin-1-(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl]
methoxy}(phenoxy)phosphoryl]amino} propanoate,
Acetyl impurity3* 0.87 4
propan-2-yl-(2S)-2-{[(S)-{[(2R,3R,4R,5R)-4-chloro-5-(2,4-dioxo-3,4-
Daclatasvir (Retention time: about 41 minutes) 1.0 dihydropyrimidin-1-(2H)-yl)- 3-hydroxy-4-methyltetrahydrofuran-2-yl]
methoxy}(phenoxy)phosphoryl]amino} propanoate ,
SSSR-Diastermer4* 1.08 5
2,3,4,5,6-pentafluoro phenol,
RSSR-Diasteromer 5*
1.14 6
propan-2-yl (2S)-2-{[(R)-{[(2R,3R,4R,5R)-2-[(3S,5S)-5,8-dimethyl-3-
oxido-6-oxo-3-phenoxy-2,7-dioxa-4-aza-315-phosphanon-1-yl]-5-(2,4-
Oxazolidine impurity 6*
1.48 dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-4-methyltetrahydrofuran-
3-yl]oxy}(phenoxy)phosphoryl]amino}propanoate,
*
Process impurity include for identification only and not included in the
calculation of total degradation products.
7
N-[(S)-(2,3,4,5,6-pentafluoro phenoxy) phenoxyphosphinyl]-L-Alanine-1-
methyl ethyl ester.
1
5,5’-biphenyl-4,4’-diylbis{2-[(2S)-pyrrolidin-2-yl]-1H-imidazole}
tetrahydrochloride, Para 2, line 6
2
methyl(1S)-1-(((2S)-2-(5-(4’-(2-((2S)-1-((2S)-2-((methoxy carbonyl)
amino)-3-methylbutanoyl)-2-pyrrolidinyl)-1H-imidazol-5-yl)-4-
Change from: sum of areas of all peak
biphenylyl)-1H imidazol-2-yl)-1-pyrrolidinyl) carbonyl)-2-methylpropyl) to : area of any other secondary peak
carbamate,
3
methyl [(2S)-1-{(2S)-2-[5-(4’-{2-[(2S)-1-acetylpyrrolidin-2-yl]-1H-
imidazol-5-yl}biphenyl -4-yl)-1H-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl
-1-oxobutan-2-yl]carbamate, Sulbactam Sodium. Page 3676
4
methyl [(2S)-1-{(2S)-2-[5-(4’-{2-[(2S)-1-{(2R)-2- [(methoxy carbonyl)
amino]-3-methyl butanoyl}pyrrolidin-2-yl]-1H imidazol-5-yl} biphenyl-4- Related substances. Reference solution (a), line 1
yl)-1H-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl] Change from: 70 mg of sulbactam IPRS
carbamate,
to : 77 mg of sulbactam sodium IPRS
5
methyl [(2R)-1-{(2S)-2-[5-(4’-{2-[(2S)-1-{(2R)-2-[(methoxy carbonyl)
amino]-3-methyl butanoyl}pyrrolidin-2-yl]-1H imidazol-5-yl} biphenyl-4- Last para, line 15
yl)-1H-imidazol-2-yl] pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]
carbamate,
Change from: sum of areas of all peak
6
methyl [(2S)-1-{(2S)-2-[5-(4’-{2-[(2S)-1-{(2S)-2-[(methoxycarbonyl) to : area of any other secondary peak
amino]-3-methylbutanoyl}pyrrolidin-2-yl]-1,3-oxazol-5-yl} biphenyl-4-yl) Assay. Line 5
-1H-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]carbamate.
Delete the following requirement
For Sofosbuvir —
“1 mg of sulbactam is equivalent to 1.094 mg of
After chromatographic system, impurity table C8H10NNaO5S.”

11
AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

Tamsulosin Hydrochloride Prolonged- (torsemide related compound A) IPRS, N-[(n-butylamino)

carbonyl]-4-[(3-methylphenyl)amino]-3-
release and Dutasteride Capsules. Page pyridinesulphonamide] (torsemide related compound B)
3715 IPRS and N-[(ethylamino)carbonyl]-4-[(3-methylphenyl)
Dissolution. For tamsulosin hydrochloride — line 2 amino]-3-pyridinesulphonamide (torsemide related
compound C) IPRS in 30 ml of methanol, with the aid of
Change from: Tablets.
ultrasound about 10 minutes and add 45 ml of 0.02 M
to: Capsules. potassium phosphate buffer pH 3.5 and dilute to 100.0 ml
with the mobile phase. Dilute 1.0 ml of the solution to
50.0 ml with the mobile phase.
Teneligliptin and Metformin Reference solution (b).Change to:
Hydrochloride Prolonged-release Reference solution (b). Dissolve 3 mg, each of, torsemide
Tablets. Page 3738 IPRS and torsemide related compound A IPRS in 3 ml of
methanol, with the aid of ultrasound for 10 minutes and add
Dissolution. Reference solution, line 1 and 2 4.5 ml of 0.02 M potassium phosphate buffer pH 3.5 and
Change from: A 0.02 per cent w/v solution of teneligliptin dilute to 10.0 ml with the mobile phase.
hydrobromide hydrate IPRS in the solvent mixture……. Last para
to : A solution of teneligliptin hydrobromide
Change to: The area of any other secondary peak is not more
hydrate IPRS containing 0.02 per cent w/v of teneligliptin in
than 0.1 per cent, the sum of the areas of all the secondary
the solvent mixture….
peaks, excluding torsemide related compound A, B and C is
Related substances. Reference solution, lines 1 to 3 not more than 0.2 per cent calculated by area normalization
Change from: A solution containing 0.05 per cent w/v, each method.
of, teneligliptin impurity A, teneligliptin impurity B and
The sum of the areas of all the secondary peaks is not more
teneligliptin hydrobromide hydrate IPRS in the solvent
than 1.0 per cent.
mixture…...
to : A solution containing 0.05 per cent w/v, each
of, teneligliptin impurity A, teneligliptin impurity B and
teneligliptin hydrobromide hydrate IPRS equivalent to Trifluoperazine Injection. Page 3866
teneligliptin in the solvent mixture……. Assay. Change to:
Assay. Reference solution Assay. To a measured volume of the injection containing 5
Change from: A 0.02 per cent w/v solution of teneligliptin mg of trifluoperazine, add 10 ml of 2 M sulphuric acid and
hydrobromide hydrate IPRS in the solvent mixture. extract with three quantities, each of 25 ml, of carbon
to : A solution of teneligliptin hydrobromide tetrachloride. Discard the carbon tetrachloride extract after
hydrate IPRS containing 0.02 per cent w/v of teneligliptin in each extraction. Add 10 ml of strong ammonia solution and
the solvent mixture. extract with five quantities, each of 50 ml, of cyclohexane.
Extract the combined cyclohexane extracts with five
quantities, each of 50 m1, of 0.1 M hydrochloric acid and
dilute the combined acid extracts to 500.0 ml with 0.1 M
Tolvaptan. Page 3832 hydrochloric acid. Measure the absorbance of the resulting
Heavy metals. Line 2 solution at the maximum at about 255 nm and 278 nm
Change from: Method D (2.4.7). Calculate the difference between two absorbance of
C21H24F3N3S in the resulting solution from the absorbance
to : Method B
obtained from the known concentration of trifluoperazine
hydrochloride IPRS in the same solvent.
Torsemide. Page 3836
Related substances. Vecuronium Bromide. Page 3928
Reference solution (a). Change to: Assay. Change to:
Reference solution (a). Dissolve 9.5 mg, each of, Assay. Dissolve 0.45 g in 50 ml of glacial acetic acid, add
4-[(3-methylphenyl)amino]-3-pyridinesulphonamide 10 ml of mercuric acetate solution. Titrate with 0.1 M

12
AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

perchloric acid, determining the end-point potentiometrically – inlet port at 250° and detector at 300°,
(2.4.25). Carry out a blank titration. – flame ionisation detector,
– split ratio of 5:1,
1 ml of 0.1 M perchloric acid is equivalent to 0.0638 g of
– flow rate: 1.0 ml per minute using nitrogen as the
C34H57BrN2O4.
carrier gas,
– injection volume: 1 μl.
Inject reference solution (a), (b) and (c). The test is not valid
Venlafaxine Prolonged-release Capsules. unless the resolution between the peaks due to 1-amino-
Page 3931 adamantan-3-ol and benzyl alcohol is not less than 2.5 in the
chromatogram obtained with reference solution (c), the
Identification. Para 2, line 1 relative standard deviation of the peak area ratio due to
1-amino-adamantan-3-ol and internal standard for replicate
Change from : Dissolve a quantity of the powdered tablets
injections is not more than 10.0 per cent in the chromatogram
to : Disperse a quantity of the mixed contents of obtained with reference solution (a) and the signal-to-noise
capsules ratio is not less than 10 in the chromatogram obtained with
reference solution (b).
Inject reference solution (a) and the test solution.
Vildagliptin and Metformin Tablets. Page Calculate the content of 1-amino-adamantan-3-ol, using
3942 (Effective from 12/04/2023) ratio of the peak area of 1-amino-adamantan-3-ol to that of
peak area of the internal standard.
Benzyltrimethylammonium hydroxide. Change to:
1-amino-adamantan-3-ol. Not more than 0.4 per cent.
Determine by gas chromatography (2.4.13).
Warfarin Tablets. Page 3963
NOTE — Use freshly prepared solutions.
Assay. Reference solution, line 2
Internal standard solution. A 0.5 per cent v/v solution of
benzyl alcohol in acetone. Dilute 1.0 ml of the solution to Change from: warfarin IPRS
10.0 ml with acetone. Dilute 2.0 ml of the solution to to : warfarin sodium IPRS
200.0 ml with acetone.
Test solution. Disperse a quantity of the powdered tablets
containing 62.5 mg of Vildagliptin in the internal standard
and vortex for 2 minutes. Then stir the solution for
Xylometazoline Hydrochloride. Page 3974
45 minutes, with the aid of magnetic stirrer, dilute to 50.0 ml Identification
with internal standard and centrifuge at 4000 rpm for
30 minutes. Use supernatant liquid. Insert before A.
Reference solution (a). A 0.000625 per cent w/v solution of Test A may be omitted, if tests B, C and D are carried out.
1-amino-adamantan-3-ol IPRS in internal standard solution. Tests B and C may be omitted if tests A and D are carried
out.
Reference solution (b). Dilute 2.0 ml of reference solution
(a) to 10.0 ml with internal standard solution. Iron. Line 1
Reference solution (c). A 0.125 per cent w/v solution of Change from : (2.4.14)
vildagliptin IPRS in reference solution (a). to : (2.3.14)
Chromatographic system Insert at the end
– a fused-silica capillary column, 15 m x 0.25 mm
“using 1.0 ml of iron standard solution (10 ppm).”
coated with crossbond 5 per cent diphenyl and
95 per cent dimethylpolysiloxane with film thickness
of 1.0 μm (Such as Rtx-5 amine),
– temperature:
column 100° for 4 minutes, 100° to 290° @ 35° per
minutes and hold at 290°, for 14 minutes,

13
AMENDMENT LIST-02 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

VITAMINS, MINERALS, AMINO AAS respectively, suitably diluted with water, for the
standard solutions.
ACIDS, FATTY ACIDS ETC.

HERBS AND HERBAL PRODUCTS

Calcium and Vitamin D3 Tablets. Page
4059
Starch. Page 4303
Dissolution. Line 6
Microbial contamination
Change from: Transfer 20 ml of the solution in to 250-ml
volumetric flask, Change from : 1 g is free from Escherichia coli and 10 g is
free from Salmonella and Shigella.
to : Transfer 20.0 ml of the solution in to 250-ml
conical flask, to : The total aerobic viable count is not more
than 1000 cfu per g, the total fungal count is not more than
100 cfu per g, determined by plate count. 1 g is free from
Escherichia coli and 10 g is free from Salmonella and
Cholecalciferol Tablets. Page 4061 Shigella.
Assay. Test solution, line 2
Change from: Calciferol VETERINARY PRODUCTS
to : Cholecalciferol
Reference solution (a). Change to:
Dexamethasone Injection. Page 4863
Reference solution (a). Dissolve 10.0 mg of cholecalciferol
IPRS in 10 ml of toluene without heating and dilute to Usual strengths.
100.0 ml with the mobile phase. Dilute 1.0 ml of the solution Change from: The equivalent of 4 mg of dexamethasone per
to 10.0 ml with the mobile phase ml in 2 ml, 5 ml and 10 ml vials.
Reference solution (b). Line 2 to : The equivalent of 4 mg of dexamethasone
Delete “ or ergocalciferol IPRS as appropriate” phosphate per ml

After chromatographic system, para 2, line 2

Delete “ or ergocalciferol”
Monobasic Sodium Phosphate. Page 4921
Last para. Line 2
Line 1
Delete “ or ergocalciferol, C28H44O”
Change to: Sodium Dihydrogen Phosphate; Sodium
Acid Phosphate

Potassium Chloride. Page 4107

Sodium. Change to: Sodium Acid Phosphate Injection. Page
Sodium. Not more than 0.1 per cent, determine by Method 4921
A for flame photometry (2.4.4) or by Method A for atomic
Add synonym
absorption spectrophotometry (2.4.2), measuring at
589 nm and using sodium solution FP, or sodium solution Monobasic Sodium Phosphate Injection

14