by maheshbhuva | Dec 19, 2025 | Analytical Chemistry, Analytical method development hplc,, QMS, Quality control (QC)
Incident Number: LAB-2025-012 Date of Incident: December 19, 2025 Product Name: Azithromycin (Finished Product) Batch Number: 33334562222 Test: Related Substances (RS) by HPLC Analyst Name: Anil Patel (ID: 5122) I. Incident Description During the HPLC analysis of...
by maheshbhuva | May 17, 2025 | Analytical Chemistry, Analytical method development hplc,, Method validation, QMS, Quality control (QC), Wheat
According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline Q2(R1), specificity is defined as:”Specificity is the ability to assess unequivocally the analyte in the presence of components...
by maheshbhuva | Nov 3, 2023 | 21 CFR, Uncategorized
21 CFR stands for Title 21 of the Code of Federal Regulations. It is a set of regulations issued by the United States Food and Drug Administration (FDA) that covers various aspects of regulatory requirements for pharmaceuticals, medical devices, food, cosmetics, and...
by maheshbhuva | Jul 25, 2023 | Glassware
The terms “Class A” and “Class B” are commonly used to describe different types of glassware in laboratory settings, particularly for volumetric measuring. These classes have specific standards and tolerances, and they serve different purposes....
by maheshbhuva | May 31, 2023 | stability
It’s 60℅ Rh because (100 – 60 = 40 ℅ loss water (100-90 = 10 ℅ loss water Here 100 is in side containers water Inside container concentration might be different but, it’s water remain 100 ℅ Share this: Click to share on Facebook (Opens in new window)...
