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Stability Testing Protocol and Method
I have contacted a compamy to do my stability testing. They asked me for my protocal and method, and I have no idea what they are asking for as this is my first time.
Can someone please explain to me what they are asking for and if possible provide an example of one.Thanks in Advance. -
6 Replies
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I would do as follows: Room temperature pulls at 1 month, 3 months, 6 months, 12 months,24 months. 40C pulls at 1 month, 3 months,and 6 months. Freeze thaw, 40/-10C pulls every 2weeks for 6 weeks starting in the -10C. Then you have to tell them what they are lookingfor. Do they need sensory tests, analytical tests (are you making claims on actives or ingredients), micro challenge?
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Thanks Mike_M
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No problem, usually the director can also guide you in what’s worth measuring or not.
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We use the Guidelines provided by the PCPC in regards to stability testing. Perry did an outstanding job on a webinar that explains it very thoroughly.
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