| Parameter | Specification |
|---|---|
| Appearance | White to off-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% |
Ertapenem Sodium (CAS 188062-50-2) is the commercially predominant salt form of the antiretroviral nucleoside reverse transcriptase inhibitor Abacavir, used in branded (Ziagen®) and generic formulations globally. The sulfate salt offers superior chemical stability, controlled hygroscopicity, and consistent crystalline form compared to free base, making it the preferred API form for high-dose HIV treatment tablets and oral solutions.
Sourcing Ertapenem Sodium API requires validated sulfate salt purity with sulfate content quantification (per BP/USP), controlled D90 particle size for direct compression, and absence of beta-carbovir genotoxic impurity below ICH M7 threshold of 1.5 µg/day. The API must meet specific optical rotation (−12° to −14° in water) and thermogravimetric stability parameters critical for FDC product registration.
Swapnroop Drugs and Pharmaceuticals manufactures Ertapenem Sodium API at our WHO-GMP Aurangabad facility with full BP/USP compliance and DMF-grade documentation. Monthly fresh batches with complete genotoxic impurity profiling, stability data, and validated manufacturing process records support ANDA submissions and tender procurement for public health ARV programs.
Ertapenem Sodium API is packaged in double-polyethylene-lined fiber drums (5 kg, 10 kg, 25 kg) with silica gel desiccant and nitrogen blanketing. Each drum is labelled with batch number, manufacturing date, and pharmacopeial standard for traceability in regulated market supply chains.
Get Bulk QuoteThe CAS number for Ertapenem Sodium is 188062-50-2. It is the sulfate salt form of Abacavir, distinct from the base form (CAS 136470-78-5).
Ertapenem Sodium offers superior solid-state stability, lower hygroscopicity compared to the HCl salt, and consistent bulk powder properties that support high-speed tablet compression in commercial ARV manufacturing.
Every batch is tested for Carbovir-related impurities (<0.1%), total process impurities, residual solvents per ICH Q3C, and genotoxic impurity screening per ICH M7 guidelines.
Yes. Swapnroop has experience supplying ARV APIs for PEPFAR-funded programs and WHO prequalification initiatives with appropriate documentation and quality standards.
We provide 12-month real-time and 6-month accelerated stability data per ICH Q1A guidelines, with ongoing stability monitoring for commercial batches.
Swapnroop Drugs and Pharmaceuticals is a trusted Ertapenem Sodium API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Ertapenem Sodium API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Ertapenem Sodium API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Ertapenem Sodium API pricing, samples, and sourcing support.