Itopride Hydrochloride API specifications guide

Monograph differences and the checks worth running on incoming material.

What Itopride Hydrochloride is used for

Itopride Hydrochloride (CAS 122892-31-3) is a benzamide-derivative gastroprokinetic compound, with dual dopamine D2-receptor antagonist and acetylcholinesterase-inhibitor activity, used as the active ingredient in formulations for functional dyspepsia and related gastrointestinal motility conditions. Full specification and sourcing detail is available on our Itopride Hydrochloride API product page.

The salt form and the identity you release against

As a hydrochloride salt, confirm that the specification, assay method, and identity testing you are quoted are explicitly built around the HCl salt form rather than the free base — a mismatch here affects both dosing calculations and identity-test interpretation, and is worth confirming in writing before the first PO.

Monograph differences that change a filing

Pharmacopoeial grade (IP/BP/USP/EP) determines the specific impurity limits and identification tests referenced in your filing. Confirm which monograph your specification is built against, and do not assume interchangeability between grades without checking.

Incoming-material checks worth running

Beyond the supplier’s Certificate of Analysis, formulators sourcing Itopride HCl commonly run incoming identity confirmation (e.g., IR spectroscopy) and assay verification as a standard quality-control step before release into formulation — this is a sound practice for any API, and particularly worth maintaining for a compound where salt-form mismatches are a known risk.

Documentation to request before the first PO

• Batch-specific Certificate of Analysis explicitly referencing the HCl salt form
• Confirmed pharmacopoeial grade and monograph reference matching your filing
• Current GMP certification type and scope — see our GMP compliance checklist
• DMF or equivalent filing status if sourcing for a regulated export market — see our DMF guide

Sourcing alongside other gastro & hepatic APIs

If Itopride is one of several gastro/hepatic APIs you are sourcing, our Metadoxine API guide covers the same documentation depth for a hepatoprotective compound commonly formulated by the same buyer base.

A short checklist before you commit

• Salt form (HCl) explicitly confirmed on the specification and CoA
• Grade and monograph reference confirmed against your filing
• Incoming identity/assay verification process in place on your side
• GMP and (if applicable) DMF status confirmed for your destination market

Frequently asked questions

Why does the salt form matter so much for this compound? Assay figures and dosing calculations depend on whether they are based on the hydrochloride salt or the free base — confirming this explicitly avoids a downstream calculation error that is easy to miss if assumed rather than checked.

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

What documentation should I request for a regulated export market? Confirm DMF or equivalent filing status for your specific destination — our plain-English DMF guide explains what that filing covers and why the timing matters to your own submission.

Is a Certificate of Analysis provided per batch as standard? Yes — a batch-wise Certificate of Analysis is issued as standard with every despatch.