by maheshbhuva | May 18, 2023 | Hplc
Phosphate buffer Citrate buffer Formate buffer Acetate buffer Tris(hydrixymethyl) -aminomethane Phosphate buffer Pka 2.1 Ph range 1.1 tob3. 1 Pka 7.2 Ph range 6.2 to 8.3 Pk 12.3 Ph range 11.3 to 13.3 Citrate Pka 3.1 Ph range 2.1 to 4.1 Pka 4.7 Ph 3.7 to 5.7 Pka 5.4 Ph...
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: Click to share on Facebook (Opens in new window) Facebook Click to email a link to a friend (Opens in new window)...
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...
