Valsartan
USP/EP-grade Valsartan (CAS 137862-53-4), 98–102%, supplied wholesale by Zyntex to licensed producers. ARB API for tablets and fixed-dose combinations, with nitrosamine risk documentation on request. CoA and SDS with every lot.
Description
Valsartan Product Overview
Valsartan (C24H29N5O3) is a white to off-white fine powder that is practically insoluble in water and soluble in ethanol and methanol. Its molecule contains a tetrazole ring, a structural feature shared with other sartans such as Losartan potassium.
Pharmaceutical companies use it in film-coated tablets and capsules in the ARB class, alone and in many fixed-dose combinations, for example with Amlodipine besylate or hydrochlorothiazide. ARBs are often compared with ACE inhibitors such as Captopril.
In 2018, nitrosamine impurities such as NDMA were found in some sartan APIs, which led to recalls and much stricter regulatory controls across the industry. Today, buyers expect a nitrosamine risk assessment and test data for every source. Zyntex supplies valsartan from qualified producers with this documentation available on request, only to licensed pharmaceutical companies.
Key Applications of Valsartan
Main application areas:
💊 Tablets
API for ARB tablets and capsules.
🔗 Fixed-Dose Combinations
Combined with amlodipine, diuretics and other APIs.
🔬 Generic Development
Development and reference material.
🧪 Analytical Use
Reference material for impurity and nitrosamine testing.
Valsartan Technical Specifications
| Parameter | Standard Value |
|---|---|
| Product Name | Valsartan (Tetrazole-Derivative API) |
| CAS Number | 137862-53-4 |
| Molecular Formula / Weight | C24H29N5O3 / 435.52 g/mol |
| Standard Grade | USP / EP / BP Quality Compliance (GMP Pharma Grade) |
| Assay / Purity (HPLC) | 98.0% to 102.0% (calculated on anhydrous basis) |
| Appearance | White to off-white fine crystalline powder |
| Heavy Metals | Max 10 ppm |
| Documents | CoA and SDS with every lot |
⚠️ Safety & Handling: Pharmacologically active substance that may damage the unborn child. Avoid inhalation of dust and contact with skin and eyes; wear gloves, eye protection and dust protection. Store in tightly closed containers in a cool, dry place. Always consult the Safety Data Sheet (SDS) for full classification and handling instructions.
Frequently Asked Questions
Can you provide nitrosamine risk documentation?
Yes. A nitrosamine risk assessment and test data from the producer can be shared on request before ordering.
Who can purchase this API?
It is supplied only to pharmaceutical companies holding the licenses required for API purchase and use in their country.
How can I get a price and documents?
Prices depend on quantity, packaging and destination. Contact us with your required volume to receive a quotation together with the CoA and SDS.
