Pharmaceutical Laboratory needed for a
USP Stability Study for controlled drug substance sterile drug product
4 Time points: Day 0, 30, 60, 180 for 25C/60%RH and 3-C/65%RH
Potency assay by LC
Endotoxin (USP 85)
Sterility (USP 71)
Particulates (USP 788)
Microorganism IDs (by either MicroSEQ or VITEK) to support environmental monitoring
TOC/Conductivity/pH to support monthly water testing
Other Pharmaceutical - Sterile testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs include :
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