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:…
Q. Do we need to initiate an OOS investigation if OOS results are found during API Method Transfer? Ans: Yes, if it happens at the originating lab. If it happens at the receiving lab, handle it through a lab incident or deviation to identify the root cause as per in-house SOP; no OOS is needed….