Most Prescribed Oral Antibiotic API – Broad-Spectrum Aminopenicillin for Bacterial Infections
| 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% |
Amoxicillin Trihydrate API (CAS 61336-70-7) is an Active Pharmaceutical Ingredient used in the formulation of prescription and/or over-the-counter pharmaceutical products. Swapnroop Drugs and Pharmaceuticals manufactures and supplies Amoxicillin Trihydrate API with pharmacopeial compliance (IP/BP/EP/USP as applicable) from our WHO-GMP certified facility in Aurangabad (MIDC Shendra), Maharashtra — one of India's premier pharmaceutical manufacturing zones with robust regulatory infrastructure.
Pharmaceutical formulation companies sourcing Amoxicillin Trihydrate API require consistent polymorphic or salt form characterisation, batch-to-batch HPLC purity ≥98% (or per specific pharmacopeial monograph), validated residual solvent control per ICH Q3C, and full impurity profiling against pharmacopeial limits. Our quality control laboratory performs complete pharmacopeial testing with USP/EP/IP validated analytical methods before every batch release.
Swapnroop's Amoxicillin Trihydrate API supply is backed by WHO-GMP certified manufacturing, a qualified vendor documentation package (CoA, MSDS, Certificate of Origin, stability data), and dedicated technical support for domestic formulation companies and international export customers. We maintain inventory for rapid order fulfilment across 25+ countries served from our Aurangabad facility.
Amoxicillin Trihydrate API is supplied in double-polyethylene-lined HDPE drums or fiber drums (25 kg net) with desiccant and nitrogen head-space. Smaller quantities (1 kg, 5 kg) in sealed HDPE jars for R&D programs. All packaging labelled with batch, grade, and pharmacopeial standard.
Get Bulk QuoteThe CAS number for Amoxicillin Trihydrate is 61336-70-7. It is the standard trihydrate form of Amoxicillin with three molecules of water of crystallisation.
The trihydrate form is the pharmacopeial standard for solid dosage manufacture, offering superior solid-state stability compared to anhydrous Amoxicillin. The controlled hydration prevents hygroscopic instability during tableting and capsule filling.
Beta-lactam ring hydrolysis (opening of the 4-membered ring) is the primary degradation pathway, leading to inactive penicilloic acid derivatives. This is accelerated by moisture, heat, and acidic or alkaline pH. Storage below 25°C in moisture-controlled packaging is essential.
Key controlled impurities include Ampicillin (pharmacopoeial related substance limit ≤1.0%), high-molecular-weight impurities (HMWPs), and process-related penicillin degradation products. Full impurity profile is included with CoA.
MOQ is 25 kg with competitive bulk pricing for 100 kg, 500 kg, and full fibre drum quantities serving India's high-volume antibiotic formulation sector.
Swapnroop Drugs and Pharmaceuticals is a trusted Amoxicillin Trihydrate 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 Amoxicillin Trihydrate API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Amoxicillin Trihydrate 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 Amoxicillin Trihydrate API pricing, samples, and sourcing support.