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Swasthya Healthcare Private Limited sell "Octreotide Injectable Solution 100 mcg/ml"

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Product Name

Octreotide Injectable Solution 100 mcg/ml

Specifications

  • Assay: Assay (HPLC): 90.0–110.0% of the labeled strength of octreotide (100 mcg/mL sterile injectable solution) on the anhydrous/dried basis, meeting the applicable pharmacopoeial monograph limit.
  • Clarity of Solution: Solution is clear and practically free from particulate matter, clear, particulate-free solution suitable for subcutaneous or intravenous administration, assessed visually against pharmacopoeial clarity standards.
  • Color of Solution: Solution color does not exceed the reference color standard (colorless to faintly yellow solution typical of the somatostatin-analogue formulation), verified by comparison with pharmacopoeial reference solutions.
  • Impurity Profile: Individual unspecified impurities ≤ 0.10% and total impurities ≤ 0.5%, per release testing for hormone-related indications, controlled by validated HPLC/UPLC methods.

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