Product Specifications
Detailed Specifications
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | ≥98.0–102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
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WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
What is Mitotane API? (CAS No: 53-19-0)
High-Quality Adrenolytic API for Adrenocortical Carcinoma Formulations
Mitotane API is an Adrenolytic (Oncology) sold in bulk as an Active Pharmaceutical Ingredient (API), positioned for companies seeking a dependable ingredient source backed by organized quality systems and scalable supply support.
Our manufacturing and supply approach for Mitotane emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.
Mitotane is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.
Key Features
- Documentation support aligned with customer qualification needs
- Batch-to-batch consistency focused for commercial supply
- Bulk packaging options designed for safe storage and dispatch
- Supply planning suited to domestic and export demand
Applications
- Suitable for formulation development and scale-up studies
- Used by pharmaceutical buyers seeking consistent raw material supply and documentation coordination
- Can support commercial procurement, validation batches, and routine production programs
- Supports manufacturers working on oncology adrenolytic dosage forms.
How to Order Mitotane API
- Send an enquiry via WhatsApp, email, or phone with your required quantity and grade.
- Receive product specifications, a CoA sample, and a formal bulk quote from our team.
- Confirm order terms, request samples if needed, and finalize documentation (MSDS, DMF, regulatory dossier).
- Receive scheduled dispatch with export documentation for domestic or international delivery.
Why Choose Us
- Consistent commercial communication and responsive quotation support
- Focus on repeatability, supply continuity, and practical business support
- Bulk packaging and logistics support for domestic and export dispatch
- Structured documentation assistance for buyer evaluation
Packaging & Supply
We offer Mitotane API in pharma-oriented packaging formats including HDPE or fiber drum options with inner protection layers, helping maintain handling quality during storage, shipping, and routine supply movement.
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