Transfer of the "Assay" and "Dissolution" analytical methods in most cases is used in comparative testing of samples. A number of practically important question remain relevant. This article addresses comparative testing of samples with transfer of these methods. Potential acceptance criteria – ...
Discuss the development & validation of dissolution test methods & acceptance criteria What does ‘quality’ mean in the context of FPPs? - 1 “Quality: The suitability of either a drug substance [=API] or drug product [=FPP] for its intended purpose” ...
Summary This chapter contains sections titled: Introduction Analytical Variability Uncertainty of the Uncertainty Estimating the Analytical Uncertainty Acceptance Criteria Assay of Drug Substances Assay of Active Ingredients in Drug Products Dissolution Testing Stability Testing Impurities Conclusions References关键...
The computational solutions for dosage uniformity and dissolution acceptance criteria are readily applicable. For dosage uniformity, the expected AV range may be determined using the s lo and s hi values along with the worst case estimates of the mean. This approach permits a risk-based assessment...
Please rate, if applicable, the supporting data on the following criteria. Is it accessible? Yes Is it clear? Yes Is it adequate? Yes Do you have any ethical concerns with this paper? No Comments to the Author Thank you for the opportunity to review this manuscript. ...
Results for Apparatus 1 are stable over time, but for Apparatus 2, the mean decreases over time. Acceptance criteria are adjusted for this trend. Lot P1 demonstrates sensitivity to test performance parameters (vessels and degassing). Conclusions Apparatus 1 results are stable over time. Those in ...
This paper describes initial test results for low-silver alloys using these solder paste alloy assessment protocols for BGAs and leaded components, and the impact of the alloys on printed circuit assembly process windows. Specific pass/fail criteria for acceptance of an alloy are not included, ...
This assessment approach only establishes the tests and data reporting requirements, not the acceptance criteria for alloys; pass/fail criteria may vary by industry segment, by company, and by product characteristics. The underlying data needed to evaluate new alloys, however, are likely to be ...