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Domperidone (Motilium) Powder Raw API Antiemetic Drug

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  • Specifications

Buy Domperidone (Motilium) Powder Raw API Antiemetic Drug CAS 57808-66-9 Online

 

Domperidone Specification

Product Name: Domperidone
CAS:57808-66-9
Content: 99%
Appearance: white powder
Packing: 25KG/cardboard drum
Ingredients: 5-Chloro-1-{1-[3-(2,3-dihydro-2-oxo-1H-benzimidazol-1-yl)propyl]-4-piperidinyl}-1,3 – Dihydro-2H-benzimidazol-2-one, calculated on dry product, containing not less than 99.0% of C22H24ClN5O2.
Physical and chemical properties: white or almost white crystalline powder, odorless, tasteless. This product is very slightly soluble in methanol, almost insoluble in water; easily soluble in glacial acetic acid.
Category: Pharmaceutical Raw Materials
Field: gastrointestinal prokinetic drugs
Deferred products: domperidone tablets, drops, suppositories, suspensions
Use: For the treatment of gastroparesis (especially diabetic gastro-light gastroparesis), the symptoms of gastric retention can be eliminated, and the gastric emptying time can be shortened; patients with moderate or more functional dyspepsia (FD) can be used Causes postprandial upper abdominal distension, upper abdominal pain, belching, early satiety, nausea, vomiting and other symptoms to completely disappear or significantly reduce
Usage and dosage: 1. Adults commonly used amount: Oral, 10 ~ 20mg or suspension 10ml, 3 to 4 times a day, taking 15 to 30 minutes before meals. 2. The amount of children commonly used: oral, 0.3 ~ 0.6mg/kg (0.1% suspension), 3 to 4 times a day, taking 15 to 30 minutes before meals.

 

What is Domperidone?

Domperidone (Motilium) is a peripherally selective dopamine D2 receptor antagonist and is used as an antiemetic, gastroprokinetic agent, and galactagogue. It may be administered orally or rectally, and is available in the form of tablets, orally disintegrating tablets (based on Zydis technology), suspension, and suppositories.

 

Domperidone Certificate of Analysis

Product name Domperidone
CAS No. 57808-66-9 Outer Packing 25kg/drum
Production date 2017.07.29 Shelf life 2022.06
Standard adopted BP
Items of analysis Specification Results
Description A White or almost white powder Almost white powder
Solubility Practically insoluble in water, soluble in dimethylformamide, slightly soluble in ethanol (96%) and in methanol Complies
Identification Melting range Between 244 and 248°C 244-246°C
Identification IR Complies
Identification TLC Complies
Identification Test for non-nitrogen substituted barbiturates Complies
Appearance of the Solution The solution should be clear and not more intensely colored than reference solution Y 6. Complies
Impurity-A Not more than 0.25 % 0.18%
Impurity-B Not more than 0.25 % Not detected
Impurity-C Not more than 0.25 % Not detected
Impurity-D Not more than 0.25% 0.20%
Impurity-E Not more than 0.25% Not detected
Impurity-F Not more than 0.25% Not detected
Un specified Impurities Not more than 0.10% Not detected
Total Impurity Not more than 0.5 % 0.38%
Heavy metals (ppm) Not more than 20 ppm Less than 20ppm
Loss on drying (%, w/w) Not more than 0.5% 0.24%
Sulphated Ash (%, w/w) Not more than 0.1 % 0.05%
Methanol Not more than 3000 ppm 780 ppm
Methyl Isobutyl ketone Not more than 5000 ppm Not detected
Methyl acetate Not more than 5000 ppm Not detected
Toluene Not more than 890 ppm 20ppm
Conclusion Qualified

 

Domperidone Application

Domperidone is used to relieve nausea and vomiting; to increase the transit of food through the stomach (by increasing gastrointestinal peristalsis); and to promote lactation (breast milk production) by release of prolactin.

 

Domperidone Side effects

Side effects associated with domperidone include dry mouth, abdominal cramps, diarrhea, nausea, rash, itching, hives, and hyperprolactinemia (the symptoms of which may include breast enlargement, galactorrhea, breast pain/tenderness, gynecomastia, hypogonadism, and menstrual irregularities).

Due to blockade of D2 receptors in the central nervous system, D2 receptor antagonists like metoclopramide can also produce a variety of additional side effects including drowsiness, akathisia, restlessness, insomnia, lassitude, fatigue, extrapyramidal symptoms, dystonia, Parkinsonian symptoms, tardive dyskinesia, and depression. However, this is not the case with domperidone, because, unlike other D2 receptor antagonists, it minimally crosses the blood-brain-barrier, and for this reason, is rarely associated with such side effects.

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