Quality Control

GENERAL 

Types of Analytical Procedures

Expression of Analytical Results

Preparation and storage of Primary Standards(Reference standards)

Determination of Solubility of a Drug substance

Forced Degradation Protocol

Peak-Valley Ratio

Procedure for Cleaning, handling and labeling of laboratory glassware.

Assay calculation by HPLC

Calculation of Related Substances by HPLC

Residual Solvents Calculation in GC (Gas Chromatography)

Monitoring of stability Chambers

Pharmacopoeial updates of USP, EP, BP, and IP monitoring and timely implementation procedure

Determination mass balance ratio in stress studies

Difference between stability and release specifications

Procedure for Receipt, Issue and Control of Reference and Impurity standards.

Disposal of Excess samples, Expired chemicals, Impurities, Reference standards and Empty reagent bottles or Solvent bottles or Containers

procedure for Conducting investigation of out of specifications (OOS) results during laboratory testing of samples.

Arrhenius Equation and Stability Studies

Stability Indicating Methods

Forced Degradation or Stress Testing

Difference between Stability[Shelf life] Specification and Release Specification

Water Content by KF

Statistical Extrapolation of Stability Data

SOP for Analysis and Reporting Received Samples

Sampling, Testing and Release of Water and Pure Steam

Analysis of Raw Materials – SOP

Retesting of all Approved Raw Materials

Repeat Analysis of Samples

Weighing of Sample on an Analytical Balance

Swab limit calculation and sample and standard concentrations for analysis

INSTRUMENT  OPERATION AND CALIBRATIONS 

Calibration of Glassware

Friability tester friability tester

Operation, Calibration and Maintenance of Eutech pH Meter,

Procedure for the operation, calibration and maintenance of Metrohm KF Titrator

Disintegration test apparatus operation and calibration

Calibration of Dissolution Test Apparatus SOP

Operation, calibration and maintenance of centrifuge

Hot air oven operation and calibration SOP

Operation, Calibration and Maintenance of Humidity chamber

Operation, Calibration and Maintenance of Photostability Chamber

Operation and Calibration of Shimadzu Prominence HPLC Quaternary System with PDA-Detector

Cooling Chamber Operation, Calibration and Maintenance procedure

Operation, Calibration and Maintenance of Orbital Shaker

Operation, Calibration and Maintenance, of Sonicator

UV Cabinet operation and calibration

Polarimeter operation and calibration

Calibration of Fourier Transform Infra-Red (FTIR) Spectrophotometer.

TOC(Total Organic carbon) Operation and Calibration SOP

Retention sample or Control samples management sop

Tap Density Tester SOP

Water bath Operation and calibration

Hardness tester for tablet operation, calibration, and cleaning

Spectrophotometer cuvettes

Determine the volume of the pycnometer

CHROMATOGRAPHY 

Chromatographic Peak Purity Interpretation

Operation and Maintenance of Mobile Phase Filtration Kit

HPLC Column Management

Procedure for Receipt, Issue, Usage and Control of HPLC & GC Columns.

General preventive Maintenance of HPLC

Selection and Cleaning of the HPLC /GC autosampler Vials

Syringe Filters in Pharmaceutical Analysis

Chromatographic peak terminology

Relative Response Factors SOP

HPLC columns

Audit trail SOP

Mobile Phase Solvents in HPLC

LIMIT TESTS 

Limit test for sulfate (IP/BP/USP)

Limit test for chloride

Limit Test for Iron IP/BP/USP

VOLUMETRIC SOLUTIONS PREPARATION AND STANDARDIZATION

Standardization of 0.1M Ammonium Thiocyanate

Standardization of 0.1M EDTA

Standardization of 0.05M EDTA

Standardization of 0.1M Ferrous Ammonium Sulphate

Standardization of 0.01M Lead Nitrate

Standardization of 0.1M Perchloric Acid

Standardization of 0.1M Silver Nitrate

Standardization of 0. 1M Sodium Hydroxide

Standardization Of 1.0 M Sodium Hydroxide

Standardization of 0.1M Sodium Thiosulphate

Standardization of 0.1M Zinc Sulphate

Standardization of 0.004M Benzethonium Chloride

0.1 M Preparation & standardization of ceric ammonium sulphate

Preparation and standardization of 1.0 M Hydrochloric acid

Standardization of 0.1 N potassium Permanganate

ANALYTICAL METHODS

Assay of Albendazole tablets 400 mg By UV Spectrophotometric method

Assay of Ciprofloxacin IP- 500mg and 250- By UV Spectrophotometric method

Assay of Paracetamol-500mg and 650mg- By UV Spectrophotometric method

Estimation of Montelukast sodium from Tablet Formulations

Estimation of Famotidine from Tablet Formulations

Estimation of acetazolamide tablets(250mg) formulation

Estimation of Amlodipine tablets(2.5/5/10mg) formulation

Estimation of Diclofenac Sodium tablets (50mg) formulation

Estimation of Enalapril maleate tablets (2.5/5/10/20 mg) formulation

Estimation of for Metformin Hydrochloride tablets (500mg) formulation.

Determination of Gliclazide(80mg) in tablet dosage form

Determination of Atorvastatin(5/10/20/40mg) in tablet dosage form

Determination of Atenolol (12.5/25/50/100mg) in tablet dosage form

Estimation of Diltiazem hydrochloride tablets(30/60/90/120mg) formulation

Estimation of loratadine tablets (10mg) formulation

Estimation of Alprazolam (0.25/0.5/1mg) in tablet formulation

Estimation of Piroxicam (20mg) in tablet formulation

Estimation of Anastrozole (1mg) in tablet formulation

Estimation of Aripiprazole (2/5/10/15/20/30mg) in tablet formulation

Estimation of Candesartan cilexetil tablets(4/8/16/32mg)

Estimation of Amiodarone hydrochloride tablets (100/200mg)

Estimation of Diltiazem hydrochloride tablets (30/90/60/120mg)

Estimation of Eplerenon tablets (25/50mg)

Estimation of Flucloxacillin capsules (250/500mg)

Estimation of Folic acid tablets (5 mg)

Estimation of Deflazacort tablets (6/12/18/24/30mg) formulation

Determination of Febuxostat tablets (40/80mg) formulation

determination of Indomethacin capsules(25mg)

Determination of Amoxycillin capsules (500mg) by UV Spectrophometric method

determination of eplerenone tablet (25/50mg) by UV Spectrophometric method

Enrofloxacin validation in Pure and Veterinary Dosage from

Estimation Of Azithromycin

HPLC Methods

Estimation of Daunorubicin Injection (20mg/4ml) by HPLC method

Estimation of Letrozole (2.5/5mg) tablets by HPLC method

Estimation of Diazepam (2/5/10mg) tablets by HPLC method

Determination of Captopril (25/50mg) tablets by HPLC method

Determination of Ondansetron hydrochloride tablets(4mg) by HPLC method

Determination of Amlodipine besylate tablets (2.5/5mg) by HPLC method

Determination of Carisoprodol tablets (350/500mg) by HPLC method.

Assay of Aceclofenac and paracetamol Tablets

TITRATION METHODS

Assay of Copper Sulphate

Assay of Sodium Benzoate

Estimation of Ephedrine Hydrochloride

Assay of Ammonium Chloride

NITROSAMINES

Determination of Nitrosamine Impurities in Metformin Drug Substance and Drug Product

Combined N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) Impurity Assay by GC/MS-Headspace in valsartan