by maheshbhuva | May 13, 2024 | Analytical Chemistry, Analytical method development hplc,, Method validation, Quality control (QC)
Type of analytical procedure validated Identification tests. Quantitative tests for impurities’ content. Limit tests for the control of impurities. Quantitative tests of the active moiety in samples of drug substance or drug product or other selected...
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
In the pharmaceutical industry, glassware is also classified based on its quality and accuracy, much like the Class A and Class B classifications commonly used in laboratory glassware. The classification of glassware in pharma is typically based on standards set by...
by maheshbhuva | Jun 6, 2023 | Analytical Chemistry, Job in pharmaceutical companies, stability
In the pharmaceutical industry, a “finished product retest” refers to the process of evaluating a sample from a previously manufactured and packaged pharmaceutical product to assess its quality, safety, and efficacy. The purpose of the retest is to ensure...
by maheshbhuva | May 22, 2023 | stability
Accelerated testing Increase the rate of chemical or physical change of drug product by using exaggerated condition as part of formal stability study. Intermediate testing conducted as at 30°C/65% designed to moderately increase the rate of chemical or physical...
