Montage Laboratories Private Limited sell "Norethisterone Tablets"
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Sell
Product Name
Norethisterone Tablets
Details
Substance
Manufacturer(s)
Specifications
- CAS Number: 68-22-4
- Molecular Weight: 298.4
- Chemical Formula: C20H26O2
- Weight Uniformity: Complies with pharmacopoeial weight uniformity/uniformity of dosage units criteria for individual tablet units.
- IUPAC Name: (8R,9S,10R,13S,14S,17R)-17-ethynyl-17-hydroxy-13-methyl-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one
- EC Number: 200-681-6
- Assay: Assay (HPLC): 90.0–110.0% of the labeled 5 mg or 10 mg strength of norethisterone on the anhydrous/dried basis, meeting the applicable pharmacopoeial monograph limit.
- Impurity Profile: Individual unspecified impurities ≤ 0.10% and total impurities ≤ 0.5%, per Montage Laboratories' cGMP-compliant release testing, controlled by validated HPLC/UPLC methods.
- Purity: Purity ≥ 98.0% by HPLC area normalization, confirmed against a certificate of analysis for each production batch.
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