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Criteria for selecting Stability Testing Parameters for JT Baker® and Macron Fine Chemical™ GMP Products (USP/NF, EP/BP, JP, ChP, and Bioreagent grades)

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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:

  • The chemical structure of the product or components of the product, they consult material safety datasheets and other relevant literatures for product information on stability, degradation paths and other properties.
  • The proper storage conditions for the product.  
  • The most likely attributes that may change during normal handling conditions which could influence product quality over time, such as appearance, loss on drying, purity.  These attributes will form the basis for testing during stability study activities. 

Based on the above select test parameters from the specifications that can be used to monitor the attributes selected.

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File Stability Testing Parameters .pdf
Keyword Stability, IPEC, Stability Studies
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