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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 2022. The original molecular weight (MW) specification for polypropylene glycol 2000 (PPG) of 1800–2200 was based on the Food Chemical Codex monograph (90%–110% of label) and not based on a scientific understanding of the process/product requirements.