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)...
by maheshbhuva | Apr 9, 2023 | Deviation, Documents error (DIN), QMS
Why investigation? To identified error Random error Impacts precision (Weight error dilution error injection to injection error Example document error, document error [ note : Precision show random error which is not control for us] +- positive and negative error...
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...
by maheshbhuva | Jan 8, 2023 | Analytical Chemistry, karl Fischer titration
Guide line935 USPType Karl Fischer titrationColoarimatry and volumetry titrationColarimatry titration because use of a electromagnetic filedVolumetric titrationThere is a manually titration (classical method like In burette fill kf reagent and conical flask fill a...
by maheshbhuva | Jan 7, 2023 | Analytical Chemistry, karl Fischer titration
DST is primary standard and it is stable up to 150 degree Centigrade. It release free water molecules easily when reacts with KF reagent.DST is easily soluble in methanol. This DST has 15.66% water molecules so we can easily calculate and standardize the KF reagent....