MEDIOCON INC is a trusted manufacturer, exporter, and bulk supplier of Oteracil Potassium API (Active Pharmaceutical Ingredient), offering premium pharmaceutical-grade raw material for formulation development, commercial pharmaceutical manufacturing, analytical testing, quality control laboratories, stability studies, and authorized pharmaceutical research applications. MEDIOCON INC manufactures Oteracil Potassium API under stringent quality management systems to ensure exceptional purity, batch-to-batch consistency, and compliance with international pharmaceutical standards.
Oteracil Potassium is an antineoplastic active pharmaceutical ingredient commonly used as a component of combination chemotherapy formulations, particularly in fluoropyrimidine-based therapies. It is widely utilized alongside Tegafur and Gimeracil in oral anticancer formulations to reduce gastrointestinal toxicity by selectively inhibiting the phosphorylation of 5-fluorouracil in the gastrointestinal tract. The API is extensively used in pharmaceutical formulation development, analytical method validation, process optimization, stability studies, and quality control applications. MEDIOCON INC supplies high-quality Oteracil Potassium API that meets stringent pharmaceutical quality standards for domestic and international pharmaceutical markets.
Every production batch manufactured by MEDIOCON INC undergoes comprehensive quality testing including identification, HPLC assay, impurity profiling, water content determination, heavy metal analysis, residual solvent evaluation, and other critical quality assessments. This rigorous quality assurance program ensures excellent pharmaceutical performance, product stability, and batch-to-batch consistency.
MEDIOCON INC supplies Oteracil Potassium API to pharmaceutical manufacturers, formulation companies, contract manufacturing organizations (CMOs), oncology research laboratories, healthcare institutions, and distributors across domestic and international markets. We provide competitive pricing, dependable bulk supply, worldwide logistics support, and complete regulatory documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and supporting quality documents upon request.
Whether your organization requires Oteracil Potassium API for commercial manufacturing, oncology formulation development, analytical testing, validation studies, or pharmaceutical research, MEDIOCON INC is committed to delivering premium-quality pharmaceutical ingredients backed by professional technical support and reliable global supply.
| Parameter | Specification |
|---|---|
| Appearance | White to Off-White Crystalline Powder |
| Identification | IR & HPLC Complies |
| Assay (HPLC) | ≥ 99.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 7.0 – 9.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 250°C – 255°C |
| Solubility | Freely Soluble in Water; Slightly Soluble in Methanol |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Oteracil Potassium API Manufacturer & Bulk Supplier in India (CAS 220210-56-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Oteracil Potassium API Manufacturer & Bulk 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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