Subcategory & Sub-subcategory
Service Name
Norethisterone
Specifications
- CAS Number: 68-22-4
- EC Number: 200-681-6
- Molecular Weight: 298.4
- Chemical Formula: C20H26O2
- 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
- Particle Size: Particle size distribution: D90 available micronized to customer-specified target (typical D90 ≤ 10 µm on request), controlled by laser diffraction to support consistent dissolution/micronization performance.
- Assay: Assay (HPLC): 97.0–103.0% 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%, supported by full CTD-DMF documentation, controlled by validated HPLC/UPLC methods.
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