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How is Aveed (Test Undecanoate) sterile, when there's no BA? Also, Oil Microembolism

ok303

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2 Questions:

How does Aveed (US Pharma test undecanoate) stay sterile, when the formula doesn't include BA? According to the package insert, it contains the hormone, castor oil, and BB.

Why is test undecanoate considered as high-risk for oil microembolism (POME)? (where the oil easily travels to the lungs) Does it have anything to do with the high BB content (~50%) or with the oil carrier, castor oil?
 

ALLEX

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First: It's already made sterile, since it's pharma. Bacteria won't grow in presence of BB.
 

ok303

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First: It's already made sterile, since it's pharma. Bacteria won't grow in presence of BB.

From what I've read, it seems BB is a co-solvent, not a bacteriostatic agent. Pharma production is sterile, using a vacuum or syringe filter sterilizes too. Why do other pharmas use BA if it's already made sterile?
 

ALLEX

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BB is a solvent, making it a harsh environment for bacteria. Pharma uses BA just in case. It's common procedure in making injectables.
 

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