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Sodium Citrate (IP) COA

The document is a Certificate of Analysis for Sodium Citrate produced by Jiaan Biotech, detailing specifications and results for various quality control tests. All tests comply with the specified standards, including appearance, solubility, and assay results. The product is manufactured in May 2021 and has an expiration date of April 2023, with a recommended storage condition of below 25°C.

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0% found this document useful (0 votes)
67 views1 page

Sodium Citrate (IP) COA

The document is a Certificate of Analysis for Sodium Citrate produced by Jiaan Biotech, detailing specifications and results for various quality control tests. All tests comply with the specified standards, including appearance, solubility, and assay results. The product is manufactured in May 2021 and has an expiration date of April 2023, with a recommended storage condition of below 25°C.

Uploaded by

vini
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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JIAAN BIOTECH , PITHAMPUR

QUALITY CONTROL DEPARTMENT


CERTIFICATE OF ANALYSIS (FINISHED PRODUCT)

Name of Product Sodium Citrate


A.R.Number : QC/070321/001 Batch No. : CP/SC/002/05/21
Date of Mfg. : 05/2021 Date of Exp. : 04/2023
Date of Receipt : 02/05/2021 Date of Release : 09/05/2021
Sampled Quantity : 50 g.

Sr. No. TEST SPECIFICATION RESULT


White, granular crystals or a white, crystalline
1.0 Description powder; odourless; slightly deliquescent in moist Complies
air.
Freely soluble in water; practically insoluble
2.0 Solubility Complies
in ethanol (95% ) and in ether.
Identification Gives the reactions of sodium salts and reaction
3.0 Complies
A BY Chemically A of citrates.

4.0 Appearance of solution Solution A is clear and colorless Complies


Not more than 0.5 ml of 0.05 M sulphuric
5.0 Acidity or alkalinity Complies
acid or 0.1 M sodium hydroxide is required.

6.0 Arsenic NMT 2 ppm LT 2 ppm

7.0 Heavy metals (Method A) NMT 10 ppm LT 10 ppm

8.0 Chlorides NMT 100 ppm LT 100 ppm


NMT 300 ppm
9.0 Oxalate LT 300 ppm
(calculated as anhydrous oxalic acid)

10.0 Sulphates NMT 150 ppm LT 150 ppm

11.0 Tartrates No crystalline precipitate is formed. Complies


Readily carbonisable The solution is not more intensely colored than
12.0 Complies
substances reference solution YS2 or GYS2
Water
13.0 11.0% to 13.0% 11.53%
(Determined on 0.3 g.)
Assay
14.0 99.0% to 101.0% 99.71%
(By Non-aqueous Titration)
Storage: Store in a well-closed container at a temperature not exceeding 25C, protected from direct
sunlight and Moisture, unless otherwise specified.

Retest Period: 2 years from the date of manufacture.

JIAAN BIOTECH , Factory Address : Plot 282-283, Pithampur Industrial Area, Sector 3 , MP
Email : info@jiaanbiotech.com Contact : +91-8349999795

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