Montage Laboratories Private Limited sell "Norethisterone Enanthate + Estradiol Valerate Injection"
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Sell
Product Name
Norethisterone Enanthate + Estradiol Valerate Injection
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Specifications
- Assay: Assay (HPLC): 90.0–110.0% of the labeled strength for each component of norethisterone enanthate (50 mg/mL) and estradiol valerate (5 mg/mL) combined on the anhydrous/dried basis, meeting the applicable pharmacopoeial monograph limit.
- Clarity of Solution: Solution is clear and practically free from particulate matter, oily injectable solution, free from visible particulate matter, assessed visually against pharmacopoeial clarity standards.
- Color of Solution: Solution color does not exceed the reference color standard (pale yellow oily solution typical of the castor-oil vehicle), verified by comparison with pharmacopoeial reference solutions.
- Impurity Profile: Individual unspecified impurities ≤ 0.10% and total impurities ≤ 0.5%, per cGMP/ISO-certified release testing at Montage Laboratories Pvt. Ltd., controlled by validated HPLC/UPLC methods.
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