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Hello,
I am looking into insight with regard to a couple of Penicillin G
Procaine formulations for which I have certificates of analysis (CofAs)
Product A claims to contain not less than 776 IU/pound
3 CofAs for product A state, respectively
Activity: 804 IU, 804 IU, and 805 IU
Active Ingredient Purity: 96.2%, 95.9%, and 96.0%
Product B claims to contain not less than 1006 IU/pound
3 CofAs for product A state, respectively
Activity: 1008 IU, 1006 IU, and 1006 IU
Active Ingredient Purity: 96.3%, 96.2%, and 96.0%
As you can see these different products, both have penicillin G
procaine as the active ingredient, have very different activities but
roughly identical active ingredient purity. Is this possible. If so,
can someone explain how? I guess this discussion may need to shed
some light on the IU.
Thanks for your help.
David
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The following message was posted to: PharmPK
Purity is generally mass to mass. The activity varies but the mass of
the
product and ratio of impurities does not. The mass measurement and
impurity is intrinsic to the sample. The activity is based on extrinsic
performance. What are the release specifications and the activity
specifications (potency) for this material.
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