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...
by maheshbhuva | May 21, 2023 | Job interview
Introduction Sun Pharmaceutical Industries Limited is a leading Indian multinational pharmaceutical company headquartered in Mumbai. The company is known for manufacturing and selling pharmaceutical formulations and active pharmaceutical ingredients in over 100...
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 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 6, 2023 | 621 USP CHAPTER
Adjustment of Mobile Phase Adjustment in composition of the mobile phase Adjustment ph of the aqueous component of the mobile phase Adjustment in concentration of salts in the buffer component of a mobile phase Adjustment in composition of the mobile phase Minor...