by maheshbhuva | May 5, 2025 | Analytical Chemistry, Analytical method development hplc,, Method validation, Pharmaceutical interview,, Quality control (QC), stability
Ah, method validation planning in pharma – a cornerstone of ensuring the quality and reliability of pharmaceutical products! It’s all about demonstrating that your analytical methods are fit for their intended purpose.To get started with effective method...
by maheshbhuva | Jul 28, 2023 | 621 USP CHAPTER, Analytical Chemistry, Hplc
What is update change Definitions Here Definitions and chromatograms both unified and give title Definitions Give method dwell volume determine being added Definitions add definitions size-exclusion chromatography (Distribution constant, Retention time of an...
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)...
by maheshbhuva | May 3, 2023 | 483 observation, Analytical Chemistry, Out of specification
Do we need to raise an OOS, if OOS result is observed during API Method transfer First defined which lab mean by At receiving lab At originating lab YES Required Caution: inform API vendor about failure Investigation release analysis Assess impact on DP(drug product)...
