Product overview
Enzalutamide is an active pharmaceutical ingredient supplied for qualified formulation, process-development and manufacturing projects. Final supply is subject to specification, documentation, regulatory assessment and destination-market requirements.
Function & Usage
- Applications
Provides functional performance in the following evaluated uses: Oncology drug-product manufacturing, API process development, Qualified pharmaceutical formulation. Final suitability depends on grade, formulation testing and destination-market requirements.
Specification
| Item | Specifications | COA Result |
|---|---|---|
| Assay | It contains not less than 98.0% and not more than 102.0% of C H F N O S, calculated on 21 16 4 4 2 the dried basis | 99.20% |
| Appearance | White to off-white crystalline powder | White crystalline powder |
| Solubility | Report Results | Acetonitrile: freely soluble Methanol: sparingly soluble Ethanol: slightly soluble Water: practically insoluble |
| Identification -IR | The infrared absorption spectrum of the substance being examined should beconcordant with the reference spectrum | Complies |
| Identification -HPLC | The retention time of the major peak in the test solution should match with the standard solution | Complies |
| Related Substances | Impurity-E: ≤0.15% | Not detected |
| Residual solvents | sopropyl alcohol: ≤0.5% | 0.03% |
| Heavy metal | ≤20ppm | Complies |
| Loss on Drying | ≤1.0% | 0.20% |
| Residue on Ignition | ≤0.1% | 0.010% |
Product information
- Primary category:
- Pharmaceuticals & Healthcare, Fine Chemicals
- Subcategory:
- Active Pharmaceutical Ingredients (APIs)
- CAS No.:
- 915087-33-1
- Form:
- Powder / Solid
- Content / Grade:
- API grade; assay and regulatory specification by quotation
- Applications:
- Oncology drug-product manufacturing, API process development, Qualified pharmaceutical formulation
- Hazard / Transport:
- For professional pharmaceutical manufacturing only. Classification, occupational controls and transport requirements must be confirmed by the current grade-specific SDS and destination-market rules.
- Storage:
- Store in the original tightly closed container under the grade-specific controlled conditions. Protect from light, moisture, heat and contamination; use controlled-temperature transport when required by the SDS.