Melphalan API is a pharmaceutical-grade Active Pharmaceutical Ingredient (API) belonging to the class of alkylating antineoplastic agents. It is a nitrogen mustard derivative of phenylalanine, chemically known as 4-[bis(2-chloroethyl)amino]-L-phenylalanine, with the molecular formula C₁₃H₁₈Cl₂N₂O₂, molecular weight 305.20 g/mol, and CAS Number 148-82-3. MEDIOCON INC supplies Melphalan API for pharmaceutical formulation and bulk API requirements.
Melphalan is used as an antineoplastic pharmaceutical ingredient and is primarily associated with formulations for the treatment of multiple myeloma and ovarian cancer. It exerts its pharmacological activity through alkylation of DNA, which interferes with DNA replication and ultimately inhibits the growth of rapidly dividing cells.
MEDIOCON INC provides Melphalan API with applicable pharmaceutical-quality documentation, including COA and MSDS, according to customer and batch requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to almost white crystalline powder |
| Identification | IR / HPLC Compliant |
| Assay (HPLC) | NLT 98.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.5 – 3.5 |
| Individual Impurity | 2.5 – 3.5 |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Specific Rotation | -31° to -34° |
| Melting Point | 208°C – 210°C |
| Solubility | Slightly soluble in water |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Melphalan API Manufacturer & Supplier in India | MEDIOCON INC (CAS 148-82-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Melphalan API Manufacturer & Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
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