Q. When is it necessary to perform in-use stability studies on solid oral dosage forms such as tablets and capsules in multi-dose containers? Ans. Data on the in-use stability of such products should be generated through a dedicated in-use stability study under long-term conditions when there is an indication from stability and/or stress studies that…
Q. What is dissolution testing, and why is it important? Dissolution testing is a critical quality control measure in pharmaceutical manufacturing that evaluates how quickly an active pharmaceutical ingredient (API) releases from its dosage form. It ensures product efficacy, consistency, and patient safety. Q. What are the stages of dissolution testing? Dissolution testing occurs in…
Q: What is the bracketing approach in stability testing? A: The bracketing approach involves testing only samples at the extremes of specific factors, such as strength, container size, or fill volume. The assumption is that intermediate samples behave similarly to these extremes. Q: When is bracketing most effective? A: It works best when there is…
Q: What is the purpose of the weight variation test in pharmaceuticals? The weight variation test is an in-process check to ensure that the finished pharmaceutical product remains within the acceptable weight range. Q: How is the weight variation test conducted? The test involves weighing 20 tablets individually and calculating the average weight. The test…
Q. What is USP Apparatus 1? USP Apparatus 1 refers to baskets, which were the first standardized apparatus added to the USP. Q. How common is the use of baskets in dissolution testing? Baskets are the second most common apparatus used in methods today due to their versatility for various dosage forms. Q. When should…
Q. What is ICH Q14? A: ICH Q14 is a guideline from the International Council for Harmonization (ICH) that focuses on analytical procedure development. It complements ICH Q2(R2), which covers method validation. Q. What are the key elements of ICH Q14? A: The key elements include: Q. What is an Analytical Target Profile (ATP)? A:…
Accelerated stability testing simulates extreme conditions to predict product shelf life. But if it fails, then refer below points: Focus on Long-Term Data: Root Cause Analysis: Regulatory Compliance: Intermediate Data: Read also:
Measuring the melting point of a substance is a critical quality control (QC) test in pharmaceuticals, as it helps to identify the substance and determine its purity. Here’s how melting point is typically measured in QC: Methods for Measuring Melting Point Equipment Used Procedure Calculations Reporting Results Regulatory Requirements Read also: Resource Person: Dhruv Jayswal
The dissolution medium contains a surfactant, like sodium lauryl sulfate (SLS) or Tween 80. The test begins smoothly, but soon enough, foam starts building up—slowly at first, then rising relentlessly. Before you know it, there’s foam all over the place, making sampling impossible and throwing your entire test off balance. Frustrating, right? The “Eureka” Moment!…
Microbial Limit Testing Tests: Acceptance Limits: As per WHO and USP <61>: Sterility Testing Tests: Microorganisms Tested: Acceptance Limits: Endotoxin Testing (Bacterial Pyrogens) Tests: Microorganisms Tested: Acceptance Limits: Environmental Monitoring Tests: Microorganisms Tested: Acceptance Limits (as per WHO/GMP): Water Testing Tests: Microorganisms Tested: Acceptance Limits (WHO): Antimicrobial Effectiveness Testing (AET) Tests: Microorganisms Used: Acceptance Limits:…