Analitik Kimya sell "AMINO ACIDS"
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Product Name
AMINO ACIDS
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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.
- Enantiomeric Purity: Controlled to ensure the specified single-enantiomer form, confirmed by validated chiral HPLC analysis.
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