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Quality Control Bolg
621 no chapter chromatography was update at on date 1-dec-2022
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...
Latest pharmacopoeia
USP 44-NF 39, which became official on November 1, 2021.
Type of Compartment of HPLC & GC ?
HPLC Going into more detail, HPLC consists of a variety of components, including a solvent delivery pump, a degassing unit, a sample injector, a column oven, a detector, and a data processor. GC GC uses an inert or unreactive carrier gas as the mobile phase, and the...
How to Re-test defined in finish product in pharma
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 that the...
Type of stability and its effect drug product in pharma industry
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....
OOS- Out of Specification Investigation – Interview Question and Answer
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)...