Subcategory & Sub-subcategory
Specifications
- CAS Number: 132539-06-1
- EC Number: 603-618-4
- Molecular Weight: 312.4
- Chemical Formula: C17H20N4S
- IUPAC Name: 2-methyl-4-(4-methylpiperazin-1-yl)-10H-thieno[2,3-b][1,5]benzodiazepine
- Polymorphic Form: Crystalline polymorphic Form II, confirmed by XRPD/DSC to ensure consistent solubility and stability batch to batch.
- Assay: Assay (HPLC): 98.0–102.0%, complying with USP-NF/EP11/CP2025 monographs of olanzapine 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 an on-file Drug Master File (DMF), controlled by validated HPLC/UPLC methods.
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