Ranitidine Hydrochloride
Ranitidine Hydrochloride (CAS 66357-59-3), withdrawn in many markets because of NDMA. Supplied by Zyntex only for documented uses such as analytical reference standards and markets where it remains authorized.
Description
Ranitidine Hydrochloride Product Overview
Ranitidine hydrochloride (C13H22N4O3S·HCl) is a white to pale yellow crystalline powder that dissolves easily in water. For decades it was one of the most widely used acid-reducing medicines.
In 2019 and 2020, regulators found that ranitidine can form N-nitrosodimethylamine (NDMA), a probable human carcinogen, during storage. As a result, the US FDA requested withdrawal of all ranitidine products, and the EU suspended them, while many other countries followed. Most producers have since switched to Famotidine or proton pump inhibitors such as Omeprazole.
Notably, today, demand comes mainly from analytical laboratories that need reference material for NDMA testing, and from licensed companies in markets where ranitidine remains authorized. Zyntex therefore supplies it only for such documented, permitted uses.
Key Applications of Ranitidine Hydrochloride
Typical uses include, for example:
🔬 Reference Standards
Material for NDMA as well as impurity testing.
🧪 Analytical Methods
Reference for method development.
💊 Authorized Markets
API where still permitted.
📋 Regulated Supply
Supply only with documented use.
Ranitidine Hydrochloride Technical Specifications
| Parameter | Standard Value |
|---|---|
| Product Name | Ranitidine Hydrochloride |
| CAS Number | 66357-59-3 |
| Molecular Formula | C13H22N4O3S · HCl |
| Assay / Purity | 97.0% – 103.0% (Dried Basis) |
| Regulatory Status | Withdrawn or suspended in many markets (NDMA) |
| Documents | CoA, SDS and end-use declaration |
⚠️ Safety & Handling: Pharmacologically active substance; may cause allergic reactions. Avoid inhalation of dust and contact, and also wear gloves and eye protection. Store in tightly closed containers in a cool, dry place, because heat can increase NDMA formation. Always consult the Safety Data Sheet (SDS), because it contains the full classification and handling instructions.
Frequently Asked Questions
Why were ranitidine medicines withdrawn?
Because regulators found that ranitidine can form the impurity NDMA during storage, many markets withdrew or suspended ranitidine products.
For which uses do you supply ranitidine?
Mainly as reference material for analytical laboratories, as well as for licensed companies in markets where it remains authorized.
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.
