by maheshbhuva | May 19, 2023 | Analytical Chemistry, stability
Chemical: Each API (active ingredient retains its chemical integrity and labeled potency within the specified limit. Physical: the physical stability properties includes appearance, palatability, uniformity, dissolution and suspend ability are retained....
by maheshbhuva | May 18, 2023 | stability
The purpose of perform stability study is that establish, based on testing a minimum of three batches of the drug substance and evaluating the stability information (including, as appropriate, results of the physical, chemical, biological, and microbiological tests),...
by maheshbhuva | Apr 5, 2023 | 621 USP CHAPTER, Analytical Chemistry
All chapter are use full for ADJUSTMENT of chromatography, TLC etc In such case some questions arias that Why adjustment in chromatography ? How adjustment justified ? Adjust chromatography If your method is validated and method are submitted in DMF so...
by maheshbhuva | Mar 9, 2023 | stability
Stability studies are mainly of following types: • Long term stability. • Intermediate stability. • Accelerated stability. • In-use stability. Share this:FacebookEmailRedditMoreTwitterLinkedInTumblrMastodonLike this:Like...