- Assay / purity
- 99.5–101.0%
- MOQ
- 25 kg
- Lead time
- 7–15 days ex-stock
Omeprazole
5-Methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazole · CAS 73590-58-6
A benzimidazole that degrades fast in acid and slowly in light — hence the enteric coat and the light-resistant pack. Supplied as a free-flowing powder with the sulfone and sulfide impurities individually controlled, since both are method-sensitive.
Part of the gastrointestinal line. Most of these are acid-labile, so the discussion usually starts with the enteric coat rather than the API.
Identity
| Catalogue no. | BP-API-018 |
| CAS number | 73590-58-6 |
| Molecular formula | C17H19N3O3S |
| Molecular weight | 345.42 g/mol |
| HS code | 2933.39 |
| Synonyms | 5-Methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazole |
| Product line | Active Pharmaceutical Ingredients |
| Category | Gastrointestinal |
Release specification
Catalogue standard below. For a supply agreement we release against your dossier specification; send it with the enquiry and the CoA will be built around it.
| Parameter | Specification |
|---|---|
| Assay | 99.0–101.0% |
| Related substances | Omeprazole sulfone ≤ 0.10%; omeprazole sulfide ≤ 0.10%; total impurities ≤ 0.5% |
| Water content | ≤ 0.5% (Karl Fischer) |
| Heavy metals | ≤ 20 ppm (ICP-MS) |
| Residual solvents | Complies with ICH Q3C Option 1 |
Application
Enteric-coated proton-pump-inhibitor pellets and capsules.
Packaging, storage & logistics
| Standard packaging | 25 kg fibre drum with double PE liner, light-resistant |
| Minimum order | 25 kg |
| Lead time | 15–25 days |
| Storage conditions | Store below 25 °C, protected from light and humidity |
| Shipping documents | Invoice, packing list, CoA, SDS, certificate of origin; DGM/IATA declaration where applicable |
Documentation provided
- CoA per batchBatch-specific, tested against the specification agreed at PO stage
- SDSCurrent GHS revision; destination-language version on request
- GMP statementSite-level GMP status and the last audit date, issued per customer
Need the DMF open part, a sample CoA or an audit pack before you can qualify us? Ask on the enquiry form — we send those documents before any commercial discussion.
Request a quotation
Related products
- Assay / purity
- 98.5–101.5%
- MOQ
- 10 kg
- Lead time
- 20–30 days
- Assay / purity
- 95.0–102.0%
- MOQ
- 25 kg
- Lead time
- 15–25 days