- Assay / purity
- 99.5–101.0%
- MOQ
- 25 kg
- Lead time
- 7–15 days ex-stock
Azithromycin Dihydrate
Azithromycin dihydrate, 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin A dihydrate · CAS 117772-70-0
A 15-membered azalide with a hydrate form that has to be preserved through drying — buyers test water content and the azithromycin B impurity together. Supplied as the dihydrate only; the anhydrous form is not offered because it re-equilibrates in suspension.
Part of the anti-infective line. These are the products where a supplier switch triggers a regulatory filing, so the CoA history and the impurity methods travel with the material.
Identity
| Catalogue no. | BP-API-006 |
| CAS number | 117772-70-0 |
| Molecular formula | C38H72N2O12 · 2H2O |
| Molecular weight | 785.03 g/mol |
| HS code | 2941.50 |
| Synonyms | Azithromycin dihydrate, 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin A dihydrate |
| Product line | Active Pharmaceutical Ingredients |
| Category | Anti-infective |
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 | 95.0–102.0% |
| Related substances | Azithromycin B ≤ 1.0%; any unspecified impurity ≤ 0.5%; total impurities ≤ 3.0% |
| Water content | ≤ 0.5% (Karl Fischer) |
| Heavy metals | ≤ 20 ppm (ICP-MS) |
| Residual solvents | Complies with ICH Q3C Option 1 |
Application
Macrolide tablets, dry-powder oral suspensions and paediatric sachets.
Packaging, storage & logistics
| Standard packaging | 5 kg / 10 kg aluminium-laminated bag in fibre drum, nitrogen-flushed |
| Minimum order | 5 kg |
| Lead time | 20–35 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