In the USP monograph of the parenteral drug some monographs need to apply the sterility test and another doesn’t need that and some monographs need to apply Endotoxin test and other doesn’t need, could you please clarify this notes
these monographs contain this sentence: Other Requirements: It meets the requirements in injections and Implanted Drug Products 〈1〉 does this sentence mean that we should apply the sterility test and endotoxin although not mentioned in the monograph or it means other requirements?
thanks with best regard
Dear Huda Ayash,
In regards to your question, first of all, I don't know what version of USP that you use. Since there was a revision for the "injections and implanted drug products (parenterals)" chapter after May 2016, some explanations had changed. We have to understand that Parenteral drug products include both injections and implanted drug products that are injected through the skin or other external boundary tissue, or implanted within the body to allow the direct administration of the active drug substance(s) into blood vessels, organs, tissues, or lesions. Injections may exist as either immediate- or extended-release dosage forms.
In the USP, there is a chapter about: PRODUCT QUALITY TESTS COMMON TO PARENTERAL DOSAGE FORMS which are consist of 2 parts: Universal test (applied/requiered by all kind of parenterals dosage form; including sterility and endotoxins) and specific tests (in addition to the universal tests, the specific tests may be considered on a case-by-case basis and, when appropriate, are referenced in the USP–NF monograph).
See the document attached and good luck!
Many thanks for your answer, we use USP 41 our question is related to the injection vials and ampoules for example in the monograph of docetaxel injection the tests don't exist sterility test , we should apply the test or not ?
Many thanks for your cooperation
In regards to your question, the answer is yes. We should apply the sterility test. Good luck!
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