Supply of ISAVUCONAZONIUM SULFATE Active Pharmaceutical Ingredient (API) and set of working standards

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Here is a summary of the current procurement information based on the submitted documents:

Procurement Object

  • Subject: ISAVUCONAZONIUM SULFATE Active Pharmaceutical Ingredient (API) and a set of 8 different working standards.
  • Key technical requirements:
    • API: 6.6 kg (preferably 4.6 kg from one batch and 2.0 kg from another), purity NLT 90%, compliance with ICH Q3C guidelines, microbiological purity (TAMC NMT 1000 CFU/g, TYMC NMT 100 CFU/g), endotoxins LT 0.9 IU/mg.
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944533-1-Isavu-sulfate-API-and-standards-TS-IUB.pdf

944533-2-Isavu-sulfate-API-and-standards-TEMPLATE-PROPOSAL.pdf

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