
N-T-BUTYL-4-ANDROSTEN-3-ONE-17BETA-CARBOXAMIDE
Price | Get Latest Price | |
Package | 1kg | 25kg |
Min. Order: | 1kg |
Supply Ability: | 2550kg |
Update Time: | 2025-04-02 |
Product Details
Product Name: N-T-BUTYL-4-ANDROSTEN-3-ONE-17BETA-CARBOXAMIDE | CAS No.: 131267-80-6 |
Min. Order: 1kg | Purity: 99% |
Supply Ability: 2550kg | Release date: 2025/04/02 |
Finasteride Impurity 5
CAS: 131267-80-6| Molecular Formula: C₂₃H₃₆N₂O₂ | Category: Pharmaceutical Impurity Standards
🌟 Product Overview
Finasteride Impurity 5 is a high-purity reference standard critical for drug development and quality control in API manufacturing. It serves as a synthesis intermediate and analytical marker for HPLC/GC testing, ensuring compliance with ICH guidelines and regulatory submissions 13.
🔑 Key Advantages
🧪 | HPLC-Certified Purity | ≥98% (UV/ELSD validated) 34 |
🔄 | Batch Consistency | ≤1% RSD across 10+ production batches |
📜 | Full Documentation | COA, HNMR, MS, IR spectra included 1 |
✅ | GMP Compliance | Manufactured under ISO 9001:2025 25 |
🎯 Applications
- API Development
: Key intermediate for Finasteride synthesis 34
- QC Laboratories
: Calibration of impurity quantification in finished drugs 16
- Regulatory Support
: FDA/EMA submission-ready data packages 2
- Academic Research
: Stability studies and degradation pathway analysis 4
📑 Quality Certifications
- ISO 17025
accredited analytical testing 5
- USP/EP
method validation compatibility 12
- Stability
: 24-month shelf life at -20°C (accelerated studies compliant with ICH Q1A) 36
📈 Market Trends
The global pharmaceutical impurity analysis market is projected to grow at 8.2% CAGR (2025-2030)1, driven by stringent regulatory requirements for generic drug approvals. Finasteride generics alone account for $1.2B annual sales2, emphasizing demand for certified impurity standards12.
Company Profile Introduction
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