Flupirtine Maleate API: sourcing a non-opioid analgesic

Grade, salt form and the documentation to line up before you formulate.

What Flupirtine Maleate is used for

Flupirtine Maleate (CAS 75507-68-5) is an aminopyridine-derivative, non-opioid analgesic that acts as a KCNQ/Kv7 potassium-channel opener with additional NMDA-receptor antagonist activity, used as the active ingredient in pain-management formulations where an opioid-alternative mechanism is desired. Full specification and sourcing detail is available on our Flupirtine Maleate API product page.

Confirm the regulatory status for your target market first

Flupirtine’s regulatory status varies notably by market — some regulators have placed restrictions on its use tied to hepatotoxicity monitoring requirements in specific finished-product indications. Confirm current regulatory status and any market-specific restrictions for your target destination before sourcing, rather than assuming approval status is uniform globally. This is exactly the kind of market-specific check covered in our buyer’s checklist for choosing an API manufacturer.

The salt form and grade selection

As a maleate salt, confirm the specification and assay method you are quoted are explicitly built around this salt form rather than the free base, and confirm which pharmacopoeial grade (where a relevant monograph exists) matches your filing requirements.

Impurity profile, packaging and route consistency

Ask your supplier whether the synthetic route is fixed and whether you would be notified of any change — a route shift can affect the impurity profile reported on your Certificate of Analysis, which matters for ongoing filing consistency. Standard packing is 1 kg, 5 kg and 25 kg HDPE drums with double LDPE liners; other configurations on request. Flupirtine Maleate should be stored in a tightly closed container, protected from light and moisture, at controlled room temperature.

Documentation to request before the first PO

• Batch-specific Certificate of Analysis explicitly referencing the maleate salt form
• Confirmed regulatory status for your specific target market, including any hepatotoxicity-monitoring-related restrictions
• Confirmed pharmacopoeial grade/monograph reference where applicable
• Current GMP certification type and scope — see our GMP compliance checklist

Sourcing alongside other pain-management or neurology APIs

Our Pregabalin API guide and Metaxalone API sourcing guide cover two other compounds commonly sourced by pain-management formulators alongside Flupirtine Maleate, each with its own distinct regulatory and specification profile.

A short checklist before you commit

• Regulatory status confirmed for your specific target market
• Salt form (maleate) explicitly confirmed on the specification and CoA
• Route consistency and change-notification policy confirmed
• Sample CoA reviewed before committing to a bulk order

Frequently asked questions

Why does regulatory status vary so much for this compound by market? Some regulators have placed restrictions on Flupirtine tied to hepatotoxicity-monitoring requirements in specific finished-product indications — always confirm current status for your specific target market rather than assuming global uniformity.

Is Flupirtine Maleate available as a standard catalogue product? Yes — see our API Manufacturing page for how standard sourcing works.

What is the difference between sourcing this as a standard product versus requiring a custom specification? A standard order sources an already-validated specification; a custom requirement would fall under a contract manufacturing or CDMO conversation — see which service you actually need if you are unsure.

Is a sample available before committing to a bulk order? Yes — evaluation samples are issued with a batch Certificate of Analysis so your QC team can test against your own specification before a bulk order.