Valsartan
| Parameter | Specification |
|---|---|
| Product Name | Valsartan |
| CAS Number | 137862-53-4 |
| Molecular Formula | C24H29N5O3 |
| Molecular Weight | 435.52 g/mol |
| Appearance | White to off-white crystalline powder |
| Assay (HPLC) | ≥ 99.0% (on dried basis) |
| Solubility | Slightly soluble in water, freely soluble in ethanol and methanol |
| Package | 25 kg fiber drum with double polyethylene liners |
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Synonyms: Valsartan, 137862-53-4, Diovan, Tareg, Exforge, CGP 48933, Valsartanum
Valsartan has become a staple in the generic cardiovascular market, with global demand driven by its well-established efficacy in hypertension and heart failure. As the patent exclusivity expired years ago, manufacturers and formulators are now focused on sourcing high-quality API from reliable suppliers to meet the growing needs of healthcare systems worldwide.
Valsartan is a non-peptide angiotensin II receptor blocker (ARB) that selectively antagonizes the AT1 receptor subtype. It is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-valine. The molecule is synthesized through a multi-step process, resulting in a white to off-white crystalline powder that is practically insoluble in water but soluble in organic solvents.
Our Valsartan is manufactured under cGMP conditions and standardized to ≥99.0% purity (HPLC). It is available in various particle sizes to suit different formulation needs, from immediate-release tablets to fixed-dose combinations. With a focus on consistency and regulatory compliance, we serve pharmaceutical companies seeking a dependable API source.
Valsartan is a small-molecule API belonging to the biphenyl tetrazole class. Its structure features a tetrazole ring that mimics the imidazole ring of angiotensin II, allowing it to block the AT1 receptor and thereby reduce vasoconstriction and aldosterone release. The API is typically supplied as the free acid, which is the active moiety in finished dosage forms.
The manufacturing process involves several synthetic steps, including amide bond formation and tetrazole ring construction. Strict control of reaction parameters ensures low levels of process-related impurities, such as the desvaleryl impurity and other specified degradants. Each batch is tested for identity, assay, and impurity profile to meet pharmacopeial requirements.
| Test Item | Specification |
|---|---|
| Identification | IR and HPLC retention time match reference standard |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 20 ppm |
| Organic Impurities | Any individual impurity ≤ 0.2%, total impurities ≤ 0.5% |
| Microbial Limits | Total aerobic count ≤ 1000 CFU/g, yeast and mold ≤ 100 CFU/g, absence of E. coli and Salmonella |
Our standard MOQ is 25 kg. For smaller quantities, please contact us to discuss your specific needs.
Lead time is generally 3-5 business days after order confirmation, depending on the quantity and destination.
Yes, we provide a COA for each batch and can supply samples for quality evaluation. Please reach out to our sales team for arrangements.
Learn more about our quality control and certifications, or send us your specification for a quotation.
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