Prokinetic / gastrointestinal API
Itopride Hydrochloride 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
Itopride hydrochloride is a prokinetic agent used in formulations for functional dyspepsia and related upper gastrointestinal motility disorders. It is a repeat-demand generic molecule, so formulators judge a source on a reproducible impurity profile and reliable delivery as much as on price when placing recurring orders.
Apex Pharma API has manufactured Itopride Hydrochloride since 2015 on a single established route, which keeps the impurity profile steady from campaign to campaign. You buy directly from the plant that makes it, with the QC team that released the batch on hand to answer your questions.
Specifications
| Product name | Itopride Hydrochloride (bulk active pharmaceutical ingredient) |
|---|---|
| CAS number | 122892-31-3 |
| Molecular formula | C20H26N2O4·HCl |
| Molecular weight | 394.89 |
| Grades available | USP · EP · In-house specification |
| Appearance | White to off-white crystalline powder |
| 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 light and moisture, at controlled room temperature |
| 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 for functional dyspepsia and related upper-GI motility disorders.
Formulations used to relieve gastric fullness, bloating and early satiety.
Reference-grade material for formulators developing sustained-release presentations.
Fixed-dose combinations where a consistent impurity profile is required across batches.
Regulatory & documentation
Everything your QA and regulatory teams need to open a file on us, issued at quotation stage rather than after the order.
Itopride Hydrochloride API — buyer questions
What is the minimum order quantity for Itopride Hydrochloride API?
Supply begins at trial quantities. The commercial MOQ is agreed against your grade and packaging requirement at quotation and is not a single fixed figure.
Can I evaluate a sample with a CoA first?
Yes. Samples are issued with the batch CoA so your QC team can verify the material against your own specification before raising a purchase order.
What is the typical lead time?
Stocked grades despatch within days of order confirmation. Campaign quantities are scheduled and a firm date is confirmed before you commit.
Do you provide specifications and DMF support?
Full specifications, batch CoA and DMF or open-part documentation are available on request. Tell us the target market and we will confirm what we can provide.
Related products
Read: Itopride Hydrochloride uses and applications →Get a Itopride Hydrochloride API quote
Grade, quantity, destination — we will come back with price, lead time and documentation.