
Pharmaceutical-grade Varenicline Tartrate (CAS 375815-87-5), min. 99%, nitrosamine-controlled, supplied wholesale by Zyntex to licensed producers. Nicotinic partial agonist API for smoking cessation tablets. CoA and SDS.
Varenicline tartrate (C13H13N3·C4H6O6) is a white to off-white powder that dissolves in water. It partially activates nicotinic receptors in the brain, which reduces cravings and the rewarding effect of smoking.
In addition, pharmaceutical companies use it in film-coated tablets with doses of 0.5 and 1 mg. In 2021, products were recalled in several markets because of the nitrosamine impurity N-nitroso-varenicline, so today specifications strictly limit nitrosamines. Similarly, other APIs in neurology in our range include Memantine Hydrochloride and Levetiracetam.
Because doses are low, content uniformity also matters. Zyntex supplies varenicline tartrate only to licensed pharmaceutical companies.
Typical uses include, for example:
💊 Tablets
API for smoking cessation tablets.
🔬 Generic Development
Development material with nitrosamine control.
🧪 Analytical Use
Reference material for impurity methods.
📋 Quality Control
Material for nitrosamine testing.
| Parameter | Standard Value |
|---|---|
| Product Name | Varenicline tartrate |
| CAS Number | 375815-87-5 |
| Assay / Purity | Min 99.0% |
| Nitrosamine Control | N-nitroso-varenicline within regulatory limits |
| Appearance | White to off-white powder |
| Documents | CoA as well as SDS with every lot |
⚠️ Safety & Handling: Pharmacologically active substance; harmful if swallowed. Avoid inhalation of dust and contact with skin and eyes, and also wear gloves, eye protection and dust protection. Store in tightly closed containers in a cool, dry place. Always consult the Safety Data Sheet (SDS), because it contains the full classification and handling instructions.
Why is nitrosamine control important for varenicline?
Because products were recalled in 2021 due to N-nitroso-varenicline, regulators now require strict limits for this impurity.
Who can purchase this API?
Only pharmaceutical companies holding the licenses required for API purchase as well as use in their country.
How can I get a price and documents?
Prices depend on quantity, packaging and destination, so please contact us with your required volume. We then send a quotation together with the CoA and SDS.