Assay: Assay (HPLC): 95.0–102.0% of octreotide (cyclic octapeptide acetate salt) on the anhydrous/dried basis, meeting the applicable pharmacopoeial monograph limit.
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Purity: Purity ≥ 98.0% by HPLC area normalization, confirmed against a certificate of analysis for each production batch.
Impurity Profile: Individual unspecified impurities ≤ 0.10% and total impurities ≤ 0.5%, per international regulatory approval standards for peptide APIs, controlled by validated HPLC/UPLC methods.
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