Criteria for selecting Stability Testing Parameters for JT Baker® and Macron Fine Chemical™ GMP Products (USP/NF, EP/BP, JP, ChP, and Bioreagent grades)
Information
Question | Criteria for selecting Stability Testing Parameters for JT Baker® and Macron Fine Chemical™ GMP Products (USP/NF, EP/BP, JP, ChP, and Bioreagent grades) |
Answer |
The stability-indicating parameters chosen to monitor product quality during stability studies are selected by a rigorous process, with the intent to accurately detect product changes that might occur in worst case scenarios involving storage, transportation or use. Test results are expected to reflect how well the product meets regulatory requirements as applicable. Our Stability program is proceduralized and references the IPEC Stability Guide or ICH Q2 as applicable: https://ipec-federation.org/wp-content/uploads/2023/02/Excipient-Stability-Guide-F.pdf https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf Stability parameter selection is determined by our Research and Technology Group; the Team reviews the following for selecting stability indicating parameters:
Based on the above select test parameters from the specifications that can be used to monitor the attributes selected. Please be aware that if you are using an older version of Adobe Acrobat Reader (5.0 or earlier, for example) the information in the attached files may not display correctly. If needed, you can visit the Adobe homepage to download the most current version of the Adobe Reader software free of charge: Adobe.com Trademarks are owned by Avantor Performance Materials, LLC. or its affiliates unless otherwise noted. |
File | Stability Testing Parameters .pdf |
Keyword | Stability, IPEC, Stability Studies |