ACKNOWLEDGEMENT
I WOULD LIKE TO EXPRESS MY SINCERE GRATITUDE TO Dr.MUNIRA
MOMIN(PRINCIPAL,SVKM’s Dr.BHANUBEN NANAVATI COLLEGE OF PHARMACY) &
PLACEMENT IN CHARGE FOR PROVIDING ME WITH AN OPPORTUNITY TO DO MY
INTERNSHIP AT ‘’FDC R&D DEAPARTMENT LTD’’.
I SINCERELY THANK MR SUDHIR SAWANT (HOD of R&D SYNTHESIS) AND MRS
PRIYA SINGH (HOD of ARDL) OF FDC R&D DEAPARTMENT PVT LTD FOR
PROVIDING ME WITH THE PRACTICAL KNOWLEDGE AND INDUSTRIAL
EXPERIENCE AT FDC PVT LTD,KANDIVALI.
I ALSO WISH TO EXPRESS MY GRATITUDE TO MRS MONIKA NAGARE
( REASEARCH ANALYST)FOR PROVIDING AND GUIDING AN INDEPTH
KNOWLEDGE OF API SYNTHESIS OF DIFFERENT DRUGS.
SVKM'S DR.BHANUBEN NANAVATI COLEGE OF PHARMACY 1
REPORT OF IN-PLANT TRAINING
NAME OF THE COMPANY ; FDC R&D DEPARTMENT LTD
ADDRESS;CHARKOP,INDUSTRIAL AREA KANDIVALI WEST.
DURATION OF INTERNSHIP;11 JUNE -12JULY 2023
NAME OF THE STUDENT;SHRAVANEE VIKAS.T
ROLL NO;B041
SIGN;
TEACHERS -IN-CHARGE;
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 2
2
TABLE OF CONTENTS
SR.NO TITLE PAGE NO.
1 ACKNOWLEDGEMENT 1
2 INTRODUCTION 2
3 GENERAL GUIDELINES 5
4 INTRO TO R&D SYNTHESIS 8
5 AUTOCLAVE 10
6 FLASH CHROMATOGRAPHY 12
7 DISSOLUTION APPARATUS 15
8 IR SPECTROSCOPY,KF APPARATUS 17
9 HPLC 20
10 GAS CHROMATOGRAPHY 25
11 CONCLUSION 27
12 TRAINING REPORT EVALUATION SHEET 28
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 3
COMPANY PROFILE
FDC LTD IS AN INDIA BASED COMPANY ,WHICH IS PRINCIPALLY ENGAGED IN THE BUSINESS OF PHARMACEUTICALS.THE
COMPANY MANUFACTURES AND DISRTIBUTES ITS RANGE OF GENERICS, FORMULATIONS AND ACTIVE PHARMA AT ITS
MANUFACTURING PLANTS ,IT ALSO MANUFACTURES ORAL REHYDRATION POWDERS (ORS) AND SPECIALIZED
FORMULATIONS.
API INCLUDES ALBUTEROL,DIHYDROCHLORIDE,MICONAZOLE NITRATE,TIMOLOL MALEATE. THERE MAIN BRANDS ARE
ELECTRAL,ENERZAL,ZIFI,VITCOFOL,MCT OIL,SIMYL ETC.
FDC LTD SHARE HAS A MARKET CAPITALIZATION OF Rs 5,218.80Cr. WITHIN PHARMACUETICAL SECTOR,IT’s MARKET CAP
RANK IS 35.
FDC HAS ITS VAROIUS UNITS LIKE IN KANIVALI FOR API SYNTHESIS,AMD DEPARTMENT,ARDL & PEPTIDES.
IN JOGESHWARI FOR CAPSULE & TABLETS FORMULATION,ORS,OPTHALMIC PREPARATIONS.
SVKM’DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 4
GENERAL GUIDELINES FOR LABORATORY DOCUMENTATION
PURPOSE;
LABORATORY DOCUMENTATION IS A TERM USED TO DESCRIBE THE MANUALS,LOGS,FILES,RECORD,REPORTS
AND PRINTED INFORMATION THAT COMES WITH INSTRUMENTS AND TEST KITS PROVIDED BY THE
MANUFACTURER.GENERALLY SOP’s ARE GIVEN TO READ BEFORE PERFORMING ANY ACITIVITY TO GO
THROUGH IT THROUGHLY.
WRITTEN RECORDS ARE REQUIRED FOR THE FOLLOWING;
1.QUALITY CONTROL & QUALITY ASSURANCE
2.PROCEDURE MANUALS
3.CALIBRATION & VALIDATION PROCEDURES
4.PERSONAL RECORDS.
GIVEN BELOW IS A LIST OF POLICIES ,MANUALS,LOGS,REPORTS,RECORDS,AND INSTRUMENT PRINTOUT THAT
ARE LOCATED IN THE LABORATORY AND /OR ADMINISTRATION OFFICE.
PERSONNEL RECORDS
IT SHOULD CONTAIN INFORMATION ABOUT EMPLOYESS,HEALTH;BLOOD;FAMILY;BACKGROUND;ETC
THE COMPANY SHOULD CONDUCTS HEALTH CHECKUP EVERY 6 MONTHS FOR ALL ITS EMPLOYESS.
INSTRUMENT LOG
A LOG IS MAINTAINED FOR EACH INSTRUMENT IN THE LABORATORY. IT SHOULD CONTAIN THE NAME,
MODEL ,SERIAL.PURCHASE DATE,MODEL,SERIAL,NUMBERS, WARRANTIES,MANUFACTURER SALES,&
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 5
TECHNICA SUPPORT CONTACT NUMBERS.
SOP
IT CONTAINS INSTRUCTIONS FOR EVERY TEST/STEP IN THE MANUFACTURING INCLUDING SPECIMEN
COLLECTION AND HANDLING.
ICH GUIDELINES
THE INTERNATIONAL COUNCIL FOR HARMONIZATION OF TECHNICAL REQUIREMENTS FOR
REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE IS A PROJECT THAT BRINGS TOGETHER THE
REGULATORIES AUTHORITIES OF EUROPE,JAPAN,AND USA.
THE ICH TOPICS ARE DIVIDED INTO 4 CATEGORIES AND ICH TOPICS CODES ARE ASSIGNED
ACCORDING INTO THESE CATEGORIES
QUALITY GUIDELINES
HARMONOZATION ACHIVEMENTS IN THE QUALITY AREA INCLUDE PIVOTAL MILESTONE SUCH AS THE
CONDUCT OF STABILITY STUDIES,DEFINING RELEVANT THRESHOLDS FOR IMPURITIES TESTING AND A
MORE FLEXIBLE APPROACH TO PHARMACUETICAL QUALITY BASED ON GOOD MAUFACTURING
PRACTICE (GMP) .
SAFETY GUIDELINES
ICH HAS THE PRODUCED A COMPREHENSIVE SET OF SAFETY GUIDELINES TO UNCOVER POTENTIAL
RISKS LIKE CARCINOGENICITY,GENOTOXICITY AND NANAVATI
SVKM'S DR.BHANUBEN REPRO-TOXICITY.
COLLEGE OF PHARMACY 6 6
EFFICACY GUIDELINES
THE WORK CARRIED OUT BY ICH UNDER THE EFFICACY HEADING IS CONCERNED WITH THE
DESIGN,CONDUCT,SAFETY,AND REPORTING OF CLINICAL TRIALS.
MULTIDICIPLINARY GUIDELINES
THOSE CROSS-CUTTING TOPICS WHICH DO NOT FIT UNIQUELY INTO ONE OF THE
QUALITY,SAFETY,AND EFFICACY CATEGORIES ARE INCLUDED UNDER THIS.IT INCLUDES THE ICH
MEDICAL TERMINOLOGY MedDRA THE COMMON TECHNICAL DOCUMENT (CTD) AND THE
DEVELOPMENT OF ELECTRONIC STANDARDS FOR THE TRANSFER OF REGULATORY INFORMATION
(ESTRI) AIR HANDLER.
SVKM’DR BHANUBEN NANAVATI COLLEGE OF PHARMACY
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY
7 7
R&D SYENTESIS DEPARTMENT
FORMOTEROL FUMARATE SYNTHESIS (FRM)
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 8
FRM
AMINE GROUP
REDUCTION
DE-BENZYLATION (IMP-A) NITRO GROUP[SECONDRY
ACYLATION AMINE]
SALT
NITROSO IMPURITY
(IMP-C)
DE-BENZYLATION
SALT FORMATION
IMPURITY C
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 9
AUTOCLAVE
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 10
AUTOCLAVE IS AN MACHINE THAT USES STEAM UNDER PRESSURE TO KILL HARMFUL
BACTERIA ,VIRUSES,FUNGI,AND SPORES ON ITEMS THAT ARE PLACED INSIDE A PRESSURE VESSEL.THE ITEMS
ARE PLACED INSIDE A PRESSURE VESSEL.THE ITEMS ARE HEATED TO AN APPROPIATE STERILIZATION
TEMPRATURE FOR A GIVEN AMOUNT OF TIME.
THE MOISTURE IN THE STEAM EFFICENCY TRANSFERS HEAT TO THE ITEMS TO DESTROYS THE PROTEIN
STRUCTURE OF THE BACTERIA AND SPORES. IN A CHAMBER THE STERILIZATION TAKES PLACE.THREE
FACTORS ARE CRITICAL TO ENSURING SUCCESSFUL STEAM STERILIZATION IN AN AUTOCLAVE;
TIME ,TEMPRATURE AND STEAM QUALITY.THREE PHASES OF AUTOCLAVE PROCESS CONDITIONING
PHASE,EXPOSURE,AND EXHAUST.
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 11
FLASH CHROMATOGRAPHY
A METHOD OF CHEMICAL SEPARATION THAT IS USED TO PURIFY CHEMICAL MIXTURES .IT IS ALSO KNOWN AS
FLASH PURIFICATION,DUE TO ITS FUNCTION AS A PURIFICATION METHOD.IT IA ALSO SOMETIMES REFFERED
TO AS MEDIUM PRESSURE CHROMATOGRAPHY.THE TECHNIQUE CAN BE USED TO ISOLATE A NATURAL
COMPONENT OR SYNTHESIZE A NOVEL MOLECULE. IT IS RELIED UPON AS ASIMPLE WAY OF SEPARATING
MOLECULES FROM COMPLEX MIXTURES.IT USES COMPRESSED GAS,SUCH AS AIR OR NITROGEN ,OR IN SOME
CASES A PUMP IS USED IN PLACE OF GAS,TO MOVE A SOLVENT THROUGH A COLUMN FILLED WITH A
PURE,SOLID MEDIUM.OFTEN SYNTHETIC SILICA IS USED TO BE SEPARATED IS INTRODUCED.
ONCE THE MIXTURE HAS BEEN INTRODUCED TO THE TOP OF THE COLUMN,COMPOUNDS WITH A HIGER
SOLUBILITY MOVE DOWN THE COLUMN AT FASTER RATES THAN THOSE WITH LOWER SOLUBILITY. GRAVITY
FACILITATES THIS MOVEMENT, WITH MORE HIGLY SOLUBLE COMPOUNDS MOVING DOWNWARDS FASTER
THAN THEN FLOW OF THE MIXTURE. THIS ALLOWS FOR THESE HIGLY SOLUBLE COMPOUNDS TO BE
COLLECTED.THESE COMPOUNDS ARE ALWAYS EXTRACTED UN A PURER STATE THAN WHEN THEY WERE
COMBINED WITHIN THE ORIGINAL MIXTURE.THE RESULTANT COMPONENTS EMEGE FROM THE BOTTOM OF
COLUMN AT DIFFERENT TIMES DEPENDING ON THEIR RATE OF DIFFUSION,ALLOWING SCIENTIST TO SEPARATE
THE COMPONENTS OF A MIXTURE BASED ON THEIR SOLUBILITY.
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 12
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 13
ANALYTICAL RESEARCH &DEVELOPMENT LABORATORIES
(ARDL)
DISSOLUTION IS A TEST USED BY THE PHARMACUETICAL INDUSTRY TO CHARACTERIZE THE
DISSOLUTION PROPERTIES OF THE ACTIVE DRUG, THE ACTIVE DRUGS RELESES AND THE
DISSOLUTION FROM A DOSAGE FORMULATION. DIFFERENT TEST METHODS ARE DESCRIBED IN
USP,Ph.Eur.AND OTHER INTERNATIONALLY HARMONIZED PHARMACOPIEAS AS WELL AS IN FDA
GUIDELINES. WHEREAS STANDARD TABLETS ARE TYPICALLY TESTED ACCORDING TO THE PADDLE
METHOD (USP2), SWELLING OR FLOATING DOSAGE FORMS SUCH AS CAPSULES ARE TESTED
USING THE BASKET METHOD(USP1).PADDLE OVER DISK (USP5) AND ROTATING CYLINDER
(USP6).METHODS ARE USED FOR TRANSDERMAL DOSAGE FORMS.THE DISSOLUTION
RATE/AMOUNT OF AN ACTIVE PHARMACUETICAL INGREDIENT (API)IS IMPORTANT FOR
CORELATING PRODUCT SAFETY AND EFFICACY.MOST COMMONLY USED DISSOLUTION
EQUIPMENT USED BEING BASKET (USP1),PADDLE (USP2)AND FLOW THROUGH CELL (USP4).
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 14
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 15
TYPE 2 APPARATUS IS PADDLE TYPE
DISSOLUTION IS SAME AS THE BASKET
TYPE EXCEPT STIRRING ELEMENT The
stirring paddle is replaced by the
basket. The metallic shaft rotates
freely and without a significant
vibration. The basket consists of
two components.
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 16
IR SPECTROSCOPY
‘’FOURIER TANSFORM INFRARED SPECTROSCOPY’’,IT RECORD SPECTRA IN INFRARED REGION CONSIST OF
OPTICAL SYSTEM CAPABLE OF PROVIDING THE MONOCHROMATIC LIGHT IN REGION OF 4000cm-400cm.
A TECHNICAL WHICH IS USED TO OBTAIN AN INFRARED SPECTRUM OF ABSORPTION OR EMISSION OF A
SOLID,LIQUID AND GAS.IN THESE EQUIPMENT AN EMPTY BEAN BACKGROUND IS RECORDED FIRST.
IT IS CALIBRATED IN EVERY 6 MONTHS USING POLYSTYRENE FILM HAVING REFRENCE CODE AS PER
CALIBRATION PROTOCOL.INFRARED SPECTROSCOPY BASICALLY DETECT FUNCTIONAL GROUP.
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 17
KF APPARATUS
A POTENTIOMETRIC TITRATION MODES,SET,DET,MET THE AUTOTITRATOR WITH KF APPARATUS
COMES WITH SPECIAL KARL FISCHER MODE.
AUTOTITRATOR TECHNIQUE IS SIMILAR TO DIRECT TITRATION WHERE NO INDICATOR IS USED.
KARL FISCHER TITRATION-ANALYSIS METHOD OF CHOICE FOR WATER CONTENT DETERMINATION IN
DIFFERENT SAMPLES.IT GIVES ACCURATE AND PRECISE RESULTS WITHIN MINUTES. WITH METTLER
TOLEDO KARL FISCHER TITRATORS YOUR OPERATOR,THE APPARATUS CONSISTS OF AN AUTOMATIC
BURETTE,A BACK TITRATION FLASK,A STIRRER,AND EQUIPMENT FOR AMPEROMETRIC TITRATION AT
A CONSTANT VOLTAGE OR POTENTIOMETRIC TITRATION AT A CONSTANT CURRENT.KARL FISCHER IS
A METHOD IN ANALYTICAL CHEMISTRY THAT USES COULOMETRIC, VOLUMETRIC OR OVEN
METHODS OF TITRATION TO DETERMINE TRACE TO PERCENT LEVEL AMOUNTS OF WATER IN
ASAMPLE.
CALIBRATION-IT IS DONE TO DETERMINE WHETHER THEIR KARL FISCHER TITRATOR IS
MEASURING MOISTURE ACCURATELY.A SIMPLE METHOD IS TO RUN A WATER STANDARD THROUGH
THE KARL FISCHER TITRATOR LIKE A NORMAL DIRECT INJECTION TEST.DEPENDING ON THE WATER
STANDARD WE USED, THE RESULT SHOULD EQUAL A PRE DETERMINED LEVEL OF MOISTURE PLUS
OR MINUS A MARGIN FOR ERROR.THESE WATER STANDARDS ARE CERTIFIED BY THE
MANUFACTURER TO EQUAL A PRECISE LEVEL OF MOISTURE.
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 18
CALIBRATION OF EACH ELECTRODE-
1)GLASS ELECTRODE
2)SOLVOTRODE ELECTRODE
3)BURETTE
4)KARL FISCHER UNIT.
KARL FISCHER IS MADE UP OF SO2 AND I2 AND BUFFER REACT WITH H+ ION .
IMPORTANT-FOR DETERMINATION OF TRACE AMOUNTS OF WATER LESS THAN 1% IT IS PREFERABLE TO USE
A REAGENT WITH WATER EQUIVALENCE FACTOR OF NOT MORE THEN 2.0
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 19
HPLC
HIGH PERFORMANCE LIQUID CHROMATOGRAPHY ,CHROMATOGRAPHY IS A TECHNIQUE FOR
SEPARATION,’’CHROMATOGRAM’’ IS THE RESULT OF CHROMATOGRAPHY AND CHROMATOGRAPH IS THE
INSTRUMENT USED TO CONDUCT CHROMATOGRAPHY .AMONG THE VARIOUS TECHNOLOGIES
DEVELOPED FOR CHROMATOGRAPHY, DEVICES DEDICATED FOR MOLECULAR SEPARATION CALLED
COLUMNS AND HIGH- PERFORMANCE PUMPS FOR DELIVERING SOLVENT AT A STABLE FLOW RATE ARE
SOME OF THE KEY COMPONENTS OF CHROMATOGRAPHS.AS REALATED TECHNOLOGIES BECAME MORE
SOPHITISCATED, THE SYSTEM COMMONLY REFERRED TO AS HIGH PERFORMANCE LIQUID
CHROMATOGRAPHY,SIMPLY BECAME REFERRED TO AS ‘LC’.NOWADAYS, ULTRA HIGH PERFORMANCE
LIQUID CHROMATOGRAPHY(UHPLC),CAPABLE OF HIGH –SPEED ANALYSIS, HAS ALSO BECOME MORE WIDE
SPREAD.
ONLY COMPOUNDS DISSOLVED IN SOLVENTS CAN BE ANALYZED WITH HPLC.HPLC SEPARATES
COMPOUNDS DISSOLVED IN A LIQUID SAMPLE AND ALLOWS QUALITATIVE AND QUANTITATIVE ANALYSIS
OF WHAT COMPONENTS AND HOW MUVH OF EACH COMPONENTS ARE CONTAINED IN THE SAMPLE.
INSTRUMENT-PREPLIQUID CHROMATOGRAPHY
MAKE- KNAUER
PUMP-PREPARATIVE PUMP 1800
PUMPHEAD-250ml SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 20
FLOW CELL PATH-2mm WHICH HAS 6.8 ml CAPACITY CAN BE CHANGED TO 4.3 ml CAPACITY.
MAX PRESSURE FOR 250 ml PUMP- 200BAR.
PARTS- PUMP,DYNAMIC MIXING CHAMBER ,INJECTOR,DETECTOR AND FRACTION COLLECTOR
PUMP-2-PUMP HAS 2 SOLVENT LINES
1)UPPER PUMP LABELED AS (B)
2)LOWER PUMP LABELED AS (A)
THE PUMP HAS DUAL PISTON PUMP HEAD WHICH CAN BE CHANGED,TO PURGE SOLVENT LINES DIP THE
SOLVENT TUBE OF EACH PUMP IN FILTERED AND DEGRADED SOLVENT BOTTLES;THEN SWITCH ON/OFF
BUTTONS OF PUMPS,SWITCH ON /OFF DYNAMIC MIXING CHAMBER,OPEN BYPASS VALVE OR PURGE
VALVE.THE PUMP WILL START THE PURGING OF SOLVENT LINE.CLOSE THE BYPASS VALVE. SELECT
INSTRUMENT –BROWSEPROJECT-LAUNCH. DIALOGUE BOX WILL APPEAR- SELECT INSTRUMENT WIZARD-
KNAUER PREP HPLC-OK.SELECT CONTROL-INSTRUMENT STATUS-CLICK ON P2-12-A-SELECT PURGE- SET
THE DSESIRE FLOW (100ml/min)-START. AFTER PURGING PREP STOP-CLOSE- CLOSE THE BYPASS VALVE.
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 21
WATERS HPLC
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 22
WATERS HPLC
COLUMN HEATER-20C-60C
SAMPLE HEATER-4C-40C
PRESSURE- 5000 psi
(120 VIALS) ABCDE (24 VIALS)
WAVELENGTH- 190- 700 nm FOR UV
190-800 nm FOR PDA
MAIN WORK-
PRIMMING OF PUMP
NEEDLE WASH
PURGE INJECTOR
SEAL WASH
LOGIN IN CHROMELON WINDOW TO CONNECT THE INSTRUMENT –OPERATION OF WATER ALLIANCE
PUMP.
A-YELLOW
B-BLUE
C-RED
D- GREEN
THESE ARE TYPES OF SOLVENT PORTS THAT ARE DIP IN
SVKM'S DR.BHANUBEN BOTTLES
NANAVATI COLLEGE OF PHARMACY 23
CALIBRATION-AFTER EVERY 6 MONTHS.
CALIBRATE THE INSTRUMENT FOR FOLLOWING PARAMETERS;
PUMP CALIBRATION-
1-ACCURACY OF FLOW RATE.
2- GRADIENT PROGRAMM CALIBRATION.
INJECTOR CALIBRATION-
1-INJECTION VOLUME ACCURACY
2-INJECTION PRECISION AND CARRY OVER STUDY
3-INJECTION LINEARITY
DETECTOR CALIBRATION-
1-WAVELENGTH CALIBRATION
2-LINEARITY OF RESPONSE OF DETECTOR
3-LAMP ENERGY CHECK
4- SIGNAL TO NOISE RATIO.
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 24
GAS CHROMATOGRAPHY
THE ANALYTICAL METHOD FOR SEPARATING AND ANALYZING COMPOUNDS THAT CAN BE
VAPOURIZED WITHOUT DECOMPOSITION.
TYPES OF GC AUTOSAMPLER-
LIQUID-HEADSPACE (RESIDUAL SAMPLES) -48 VIALS
SPME(SOLID PHASE MICRO EXTRACTION)
1) LIQUID AUTOSAMPLER
IT IS USED FOR INJECTING THE LIQUID SAMPLE DIRECTLY INTO THE INLET PORT.
2)HEADSPACE GC- TECHNIQUE BY WHICH AN ALIQUOT OF ANALYTE FORM A SOLID OR HIGH
BOILING LIQUID SAMPLE IS EXTRACTED AND INJECTED INTO THE CHROMATOGRAPHY
3)SPME-SOILD PHASE EXTRACTION SAMPLING TECHNIQUE THAT INVOLVES THE USE OF A FIBRE
COATED WITH AN EXTRACTING PHASE IT CAN BE LIQUID OR SOLID (SORBENT) .
4) FLAME IONIZATION DETECTOR.
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 25
MODEL-CLARUS 600
CLOUMN LENGTH-
1-INJECTOR- 44mm-51mm
2-DETECTOR-75mm-81mm
CALIBRATION –AFTER EVERY 6 MONTH.
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 26
CONCLUSION
FROM THE EXPERIENCED GAINED AT FDC R&D PVT LTD,KANDIVALI MUMBAI;IT WAS EVIDENT THAT
ALL DEAPARTMENTS STARTING FROM API SYNTHESIS,ARDL DEAPARTMENT AND AMD
DEPARTMENT ARE EQUALLY IMPORTANT IN COMPANY .THE HANDS ON EXPERIENCE ON VARIOUS
INSTRUMENTS AT FDC HELPED IN LINKING THEORETICAL PHARMACUETICAL LNOWLEDGE WITH
CURRENT PRACTICAL RESEARCH KNOWLEDGE.
THE INTERNSHIP HELPED IN UNDERSTANDING DIFFERENT REGULATION NECESSARY WHILE
DEVELOPING OR CALIBRATING DOSAGE FORM. THERE ARE LOTS OF RULE AND STANDARD
OPERATING PROCEDURES WHICH ARE TO BE FOLLOWED WHILE FORMULATING A PRODUCT.ALL
THE DEAPARTMENTS WORKS TOGETHER ,THEY ARE REATED TO EACH OTHER.THE API SYNTHESIS
DEAPARTMENT SEND THEIR SAMPLE TO ARDL DEAPARTMENT FOR CHECKING THE PURITY
PERCENTAGE OF SAMPLE IN HPLC,GC OR IN LCMS ETC.
THEN OTHERS SAMPLES FROM JOGESWARI ARE SEND TO KANDIVALI FOR CHECKING WHICH ARE
TRIAL PHASE.WHERE THE SAMPLES ARE CHECKED AND SEND FOR PACKAING AND LABELING.THIS
INTERNSHIP TRAINING HELPED ME TO ACCUIRE KNOWLEDGE ON PUNCTUALITY,REGULARITY AND
WORKING IN ITHE INDUSTRY.
SVKM'S DR.BHANUBEN NANAVATI COLLEGE OF PHARMACY 27
