High-Quality Active Pharmaceutical Ingredient for Antidiabetic Formulations
| 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 Sitagliptin HCL Monohydrate API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Sitagliptin HCL Monohydrate is supplied by Swapnroop with a focus on consistent quality control, transparent documentation, and dependable order fulfilment for pharmaceutical buyers.
Buyers sourcing Sitagliptin HCL Monohydrate from Swapnroop benefit from a straightforward quotation process, consistent batch-to-batch quality, and responsive technical coordination.
Sitagliptin HCL Monohydrate is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.
Packaging for Sitagliptin HCL Monohydrate is selected to balance protection and practicality — HDPE/fiber drum options with inner liners are available depending on order size and destination.
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The CAS number for Sitagliptin HCL Monohydrate API is 654671-77-9. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.
Sitagliptin HCL Monohydrate API is available in IP, BP, EP, and USP pharmacopeial grades with quality testing per pharmacopoeial and in-house specifications. All batches come with full CoA and MSDS.
Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Expedited supply is available for larger volumes.
Yes, Swapnroop provides full DMF-grade documentation for Sitagliptin HCL Monohydrate API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.
Yes, Swapnroop exports Sitagliptin HCL Monohydrate API to 40+ countries including the USA, UK, UAE, Germany, Australia, South Africa, Nigeria, Kenya, Brazil, and Southeast Asian markets. We provide full export documentation and regulatory support.
For companies evaluating Sitagliptin HCL Monohydrate API manufacturer options in India, this page offers a clear overview of the product profile, quality approach, and supply readiness.
Our team works with buyers who need Sitagliptin HCL Monohydrate API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.