Hepatoprotective API
Metadoxine API
Manufactured in-house at our Saykha GIDC plant in USP, EP and in-house specification grades — supplied with batch CoA as standard and DMF support for regulated filings.
Overview
Metadoxine is a hepatoprotective agent used in formulations for alcoholic and non-alcoholic liver conditions and to support recovery in alcohol intoxication. It is a hygroscopic molecule, so formulators need a supplier who controls both the impurity profile and the water content and packs the material to protect it through storage and transit.
Apex Pharma API has manufactured Metadoxine since 2015 on a single established route, keeping the impurity profile consistent between campaigns. You buy directly from the plant that makes it, with the QC team that released the batch available to answer your questions.
Specifications
| Product name | Metadoxine (bulk active pharmaceutical ingredient) |
|---|---|
| CAS number | 74536-44-0 |
| Molecular formula | C13H18N2O5 |
| Molecular weight | 286.28 |
| Grades available | USP · EP · In-house specification |
| Appearance | White to off-white crystalline powder (hygroscopic) |
| Assay | Per applicable pharmacopoeial monograph (grade-specific) |
| Packaging | 1 kg / 5 kg / 25 kg — HDPE drum with double LDPE liner; other configurations on request |
| Storage | Store in a tightly closed container, protected from moisture and light, at controlled room temperature — material is hygroscopic |
| Supply capacity | Trial quantities to repeat commercial volumes — confirmed at quotation |
Full specification sheet and method of analysis issued with the quotation. Packaging and storage confirmed per destination market.
Applications
Oral solid dosage forms used in the management of alcoholic and non-alcoholic liver conditions.
Formulations indicated to support recovery in acute and chronic alcohol intoxication.
Fixed-dose combinations where a consistent impurity profile is required across batches.
Reference-grade material for formulators building generic and regulated-market filings.
Regulatory & documentation
Everything your QA and regulatory teams need to open a file on us, issued at quotation stage rather than after the order.
Metadoxine API — buyer questions
What is the MOQ for Metadoxine API?
We ship from trial quantities upward. The commercial minimum is set against your grade and pack size at quotation rather than fixed for every buyer.
Do you send a sample with a CoA?
Yes. Evaluation samples are issued with the batch CoA so your QC team can verify assay and water content against your specification before ordering.
How should moisture-sensitive material be planned for delivery?
The API is hygroscopic and is packed in HDPE drums with a double LDPE liner. Stocked grades despatch within days; campaign volumes are scheduled with a firm date.
Can you support a DMF or dossier?
DMF support and open-part documentation are available on request. Tell us the destination market and we will confirm the documents we can supply.
Related products
Read: Metadoxine uses and applications →Get a Metadoxine API quote
Grade, quantity, destination — we will come back with price, lead time and documentation.