Overview
A first-generation ethanolamine antihistamine used in sleep aids, cold combinations and (with pyridoxine) for nausea in pregnancy. Backed by US-DMF, EDMF and WC-FDA files.
Specifications
| CAS | 562-10-7 |
| Standard | USP |
| Category | API |
| Regulatory files | EU WC GD250028 · FDA CPP H9AE-5J4P (Mexico) |
| Therapeutic area | Antihistamines |
Regulatory support
Available under NDA for qualified products.
Safety Data Sheet (SDS) & CoA
An SDS and a representative CoA are available for every catalogue product. For your compliance or qualification file, request them by email or the RFQ form — our team releases them together with the documentation package you need.
Request the SDS & CoA by emailImpurity reference standards for this API 10
We also synthesize the pharmacopeial and process impurities of this API (identified by CAS number — the only reliable key). Browse them or request the list by email.
See its impurity standardsRequest documentation & quotation
Specify your target market and annual volume; we'll reply with the relevant dossier and price.
Ask for the dossier
GMPUS FDA inspectedUSP
