WHO-GMP Certified Active Pharmaceutical Ingredient Supplier
| 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% |
Get Bulk Quote for isosorbide mononitrate API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Isosorbide mononitrate API (CAS 16051-77-7) is an active pharmaceutical ingredient used in the manufacture of pharmaceutical formulations. As a leading Isosorbide mononitrate API supplier and manufacturer in India, Swapnroop Drugs & Pharmaceuticals ensures high purity, consistent quality, and full compliance with international pharmacopeial standards for global regulated and semi-regulated markets.
Pharmaceutical companies sourcing Isosorbide mononitrate API evaluate HPLC purity (≥98.0%), impurity profile control (ICH Q3A compliant), residual solvent content (ICH Q3C), and polymorphic form consistency. Batch-to-batch reproducibility in particle size distribution (D90, D50) is critical for consistent dissolution performance and tablet compressibility in downstream formulation.
Swapnroop Drugs and Pharmaceuticals supplies Isosorbide mononitrate API from our WHO-GMP certified Aurangabad facility with complete IP/BP/EP/USP pharmacopeial compliance. We support ANDA/NDA filing through DMF-referenced documentation, provide fresh monthly batches with validated shelf life, and export to 25+ countries with full regulatory dossier support.
Isosorbide mononitrate API is supplied in triple-layer HDPE drums (5 kg, 10 kg, 25 kg) with moisture barrier inner bags and nitrogen purge to preserve API purity and pharmacopeial compliance during storage and international transit.
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The CAS number for Isosorbide mononitrate API is 16051-77-7. Please verify the exact salt or hydrate form you require as different forms carry distinct CAS numbers"faq-item">
Isosorbide mononitrate API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC assay 98.0–102.0%, full impurity profiling per ICH Q3A, and pharmacopeial identification testing (IR, HPLC).
Minimum order is 1 kg for R&D sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Expedited supply available for urgent requirements.
Yes, Swapnroop provides full DMF-grade documentation for Isosorbide mononitrate API including CoA, MSDS, impurity report, stability data, and complete regulatory dossier support for USFDA, EMA, and CDSCO submissions.
Swapnroop Drugs and Pharmaceuticals is a trusted Isosorbide mononitrate 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 Isosorbide mononitrate API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Isosorbide mononitrate 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 Isosorbide mononitrate API pricing, samples, and sourcing support.