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Is endotoxin testing considered an essential part of shelf-life specification to confirm parenteral products to be pyrogen-free?

刊登日期：2019-11-22  |  點閱次數 : 2827 次 

No. Endotoxin testing is not requested in shelf-life stability test, taking into account the fact that it is not considered a stability-indicating parameter. However, the applicant should demonstrate integrity of the container to make sure that quality is guaranteed during shelf-life.

 

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