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1. Pyrogen and Endotoxins Testing: Questions and Answers - FDA

When is the USP Chapter <151> Pyrogenicity Test (the rabbit pyrogen test)
appropriate? .7. 10. How would an appropriate endotoxins limit .... Gel Clot Limits
Test, Interpretation, for guidance on repeat testing. As specified in. Chapter <85>,
if the test .... eDocuments/UCM089360.pdf. Manufacturing changes for Class I
and II ...
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2. USP <797> Pharmaceutical Compounding -Sterile - SEFH

〈797〉 Pharmaceutical Compounding—Sterile Preparations 1. Change to read: ...
bial contamination (nonsterility), (2) excessive pounding (see Pharmaceutical
Compound- bacterial endotoxins, (3) ..... a suitable sterile transfer device or
dispensing set,containers, and closure-sealed containers when so which allows
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