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Domperidone Maleate is a potent gastroprokinetic and antiemetic API widely used in the treatment of nausea, vomiting, and gastrointestinal motility disorders. It functions as a dopamine D2 receptor antagonist, enhancing the movement of the stomach and intestines and preventing feelings of nausea.
At Bluepill Express, we specialize in manufacturing and exporting Domperidone Maleate API that adheres to IP, BP, and USP pharmacopoeial standards. Our API exhibits excellent assay value, low impurity profile, and superior stability, making it ideal for global pharmaceutical formulations.
Therapeutic Uses
- Management of nausea and vomiting due to drugs or gastrointestinal disorders
- Treatment of gastroparesis and indigestion
- Adjunct in therapy for reflux esophagitis
- Improves gastric emptying in patients with motility issues
- Commonly combined with Pantoprazole, Omeprazole, or Esomeprazole in gastro formulations
Mechanism of Action
Domperidone Maleate works by blocking peripheral dopamine D2 receptors in the gastrointestinal tract and the chemoreceptor trigger zone (CTZ) of the brain.
This action leads to:
- Increased gastric motility and emptying
- Enhanced esophageal peristalsis
- Reduction in nausea and vomiting
Unlike Metoclopramide, Domperidone does not cross the blood-brain barrier, significantly reducing central nervous system side effects such as drowsiness.
Pharmacological Information
- Chemical Name: 5-Chloro-1-[1-[3-(2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)propyl]-4-piperidyl]-1,3-dihydro-2H-benzimidazol-2-one maleate
- Molecular Formula: C22H24ClN5O2·C4H4O4
- Molecular Weight: 558.09 g/mol
- CAS Number: 99497-03-7
- Therapeutic Category: Antiemetic / Gastroprokinetic
- Pharmacopoeial Standards: IP / BP / USP
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White or almost white crystalline powder |
| Solubility | Slightly soluble in water, freely soluble in methanol |
| Melting Point | 233°C – 236°C |
| pH (1% solution) | 5.0 – 7.0 |
| Assay (as C22H24ClN5O2·C4H4O4) | 98.0% – 102.0% |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR, UV – Complies |
| Assay (Purity) | 98.0% – 102.0% |
| Related Substances | ≤ 0.5% (individual), ≤ 1.0% (total) |
| Water Content | ≤ 0.5% |
| pH (1% solution) | 5.0 – 7.0 |
| Heavy Metals | ≤ 20 ppm |
| Storage Conditions | Store in a cool, dry, and well-ventilated area |
Applications
- Tablet formulations (alone or with PPIs like Pantoprazole, Omeprazole, or Esomeprazole)
- Oral suspension and syrup formulations
- Capsules and dispersible tablets
- Combination therapies for nausea and gastric motility enhancement
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (as per ICH guidelines)
- DMF / Regulatory dossier (available on request)
Packaging & Export Details
| Packaging Type | Net Weight |
|---|---|
| HDPE Drum | 25 kg |
| Fiber Drum | 25 kg |
| LDPE Bag (liner) | 1 kg / 5 kg / 10 kg |
- Shelf Life: 5 years under recommended storage
- Labeling: Product name, batch no., MFG & EXP date, net weight, storage conditions
- Export Markets: Asia, Africa, Middle East, Latin America, CIS & Europe
