Ledipasvir Intermediate: Comprehensive User Guide for Pharmaceutical Applications
Table of Contents
1. Product Specifications & Comparative Analysis
| Parameter | Ledipasvir Intermediate | Generic Alternatives |
|---|---|---|
| Purity | ≥99.5% | 98.0-99.2% |
| CAS Number | 1370468-36-2 | Varies |
| Storage | 2-8°C (Desiccated) | Ambient |
2. Therapeutic Applications & Mechanism
Ledipasvir Intermediate serves as critical raw material in:
- NS5A inhibitor synthesis for Hepatitis C Virus (HCV) regimens
- Combination therapies with Sofosbuvir
- Pan-genotypic formulations
3. Manufacturing Protocols
Step 1: Controlled environment handling (RH ≤40%)
Step 2: Solvent mixture ratio optimization (DMF:Acetonitrile = 3:7)
Step 3: HPLC monitoring (retention time: 8.2±0.3 min)
4. Industrial Implementation Cases
Case A: API manufacturer achieved 22% yield improvement through our intermediate’s enhanced stability
Case B: Reduced impurity profile from 0.8% to 0.2% in final dosage forms
5. Verified Client Implementations
| Client | Application | Outcome |
|---|---|---|
| PharmaTech Solutions (Germany) | HCV Combination Therapy Production | 15% Cost Reduction |
| BioSynth Ltd. (USA) | Generic Drug Development | FDA Approval Accelerated by 6 Months |
6. Technical Support & Quotation
Contact our chemistry experts for:
- Custom synthesis requirements
- Bulk order pricing (MOQ: 5kg)
- Regulatory documentation support
Email: info@vivalr.com
Tel: (86) 15866781826
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