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Almac Group sell "API Services, Chemical Development & Manufacture"

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Basic Information

619
41
3
4.3(74)

Trade Type

Sell

Service Name

API Services, Chemical Development & Manufacture

Service Provider(s)

Specifications

  • Purity: Complies with pharmacopeial or in-house purity specification, confirmed per batch by validated analytical methods (e.g., HPLC) and documented in the Certificate of Analysis.
  • Assay: Assay content determined by a validated HPLC or titrimetric method and reported on an as-is or anhydrous basis in the Certificate of Analysis.
  • Impurity Profile: Individual and total related-substance impurities are controlled and reported in line with ICH Q3A/Q3B guidance, as documented in the Certificate of Analysis.
  • Loss on Drying: Loss on drying is determined by the relevant pharmacopeial method (e.g., USP/Ph. Eur.); the batch-specific result is reported in the Certificate of Analysis.

Documents

Other
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