Mediocon Inc. is a trusted supplier and exporter of Eteplirsen API, providing high-quality pharmaceutical raw materials for global pharmaceutical and biotechnology companies. Eteplirsen is an antisense oligonucleotide therapeutic agent designed for the treatment of Duchenne muscular dystrophy (DMD) in patients with specific genetic mutations.
Our Eteplirsen API is supplied with stringent quality control, ensuring purity, consistency, and compliance with customer requirements. We provide complete documentation support including Certificate of Analysis (COA), MSDS, specification sheets, and regulatory documents.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white powder / lyophilized solid |
| Identification | IR & HPLC Complies |
| Assay (HPLC) | 90.0% – 110.0% |
| Loss on Drying | NMT 10.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 6.0 – 8.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 5.0% |
| Water Content | NMT 10.0% |
| Specific Rotation | Not Applicable |
| Melting Point | Not applicable (decomposes at high temperature) |
| Solubility | Freely soluble in water; practically insoluble in organic solvents |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Eteplirsen API Manufacturer & Supplier in India (CAS 1207676-19-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Eteplirsen API Manufacturer & Supplier in India 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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