MEDIOCON INC is a trusted manufacturer, exporter, and bulk supplier of Norethisterone Acetate 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 Norethisterone Acetate API under stringent quality management systems to ensure exceptional purity, batch-to-batch consistency, and compliance with international pharmaceutical standards.
Norethisterone Acetate is a synthetic progestin active pharmaceutical ingredient widely used in pharmaceutical formulations for the management of menstrual disorders, endometriosis, abnormal uterine bleeding, secondary amenorrhea, contraception, and hormone replacement therapy (HRT). The API is extensively utilized in tablets, hormonal formulations, analytical method validation, process optimization, stability studies, and quality control applications. MEDIOCON INC supplies high-quality Norethisterone Acetate 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 Norethisterone Acetate API to pharmaceutical manufacturers, formulation companies, contract manufacturing organizations (CMOs), 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 Norethisterone Acetate API for commercial manufacturing, 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) | 98.5% – 101.5% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |
| Specific Rotation | +33° to +39° |
| Melting Point | 160°C – 165°C |
| Solubility | Soluble in Acetone and Chloroform; Slightly Soluble in Ethanol; Practically Insoluble in Water |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Norethisterone Acetate API Manufacturer & Bulk Supplier in India (CAS 51-98-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Norethisterone Acetate 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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