Quality Control

GMP Inspection Checklist & Most frequently asked questions about HPLC HPLC is an abbreviation for 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. HPLC dedicated to molecular separation called columns and high-performance pumps for …

Water Analysis  as per IP/BP/USP Procedure for chemical testing and microbiological testing of Raw/Tap water, RO water, and purified water samples. Procedure for Water Analysis (Chemical & Microbiological) Carry out the determination under conditions designed to avoid extrinsic microbial contamination of the water sample for the analysis. The precautions taken …

Troubleshooting There is no standard troubleshooting procedure. General Pattern: Locate the problem by ranking possible causes. Verify the presence of the most probable cause. If present – fix the problem, otherwise verify the existence of the next possible cause. Two Types  of HPLC troubleshooting System problems or Method problems HPLC …

Reference-Standard and Working Standards The US Food and Drug Administration defines a reference-standard material as a “highly purified compound that is well characterized” (1). The US Pharmacopeia (USP) defines reference-standard materials as “highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators” (2). Scientists …

HPLC Interview Questions Question 1: What is Full form of HPLC? Answer: HPLC stands for High-performance Liquid Chromatography or High-pressure Liquid Chromatography. Question 2: What is HPLC Principle? or What is Principle of Chromatography? Answer: It is a chromatographic technique used to separate the components from a mixture of a …

SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA AS PER ICH Q6 A GUIDELINE Question – 1: The objective of the ICH Q6 A Guideline? Answer: ICH Q6 A Guideline is intended to assist in the establishment of a single set of global specifications for new drug substances and new drug products. …

Quality Risk Management in Analytical Laboratory The Quality of the Product Drugs or Drug Product is evaluated in Quality Control analytical laboratories, So It is important to understand that the “services” and “output” of a Quality Control / Analytical Laboratory is directly related to Safety, Identity, Strength, Purity (efficacy), Quality …

IMPURITIES IN NEW DRUG SUBSTANCES To provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state Impurities in new drug substances are addressed from two perspectives: Chemistry Aspects include classification …

HPLC (Questions & answers) Q.1- What is the difference between C8 and C18? Answer: – C8 has 8 carbon atoms and C18 has 18 carbon atoms, C18 is more hydrophobic than C8 due to that C18 has a long retention time and C8 has a sort retention time (early). Q.2- …

Dissolution (Question & Answer) 1. Question: What is dissolution? Answer:  Dissolution is the time require to release the active drugs substances into liquid form in a dissolution medium under setup conditions (RPM, Time, and Temperature). 2. Question: What is USP chapter No. for Dissolution? Answer: USP chapter No, <711> 3. …