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Promethazine Hydrochlorine 58-33-3 Pharmaceutical Raw Materials
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Antitussive Drug Pharmaceutical Raw Materials Promethazine
Hydrochlorine
Quack Detail for Promethazine hydrochloride
Product Name | Promethazine hydrochloride |
Synonyms | phenothiazine hydrochloride;Promethazine Hcl |
CAS | 58-33-3 |
MF | C17H21ClN2S |
MW | 320.88 |
EINECS | 200-375-2 |
Purity | 99% |
Appearance | White Solid |
Grade | Pharma Grade |
Usage | For the treatment of allergic disorders, and nausea/vomiting. |
Packing | For the treatment of allergic disorders, and nausea/vomiting. |
Storage | Store in cool and dry area and keep away from direct sunlight. |
Promethazine hydrochloride is a phenothiazine used to treat or prevent nausea and vomiting caused by anesthesia or surgery, certain types of allergic reactions, pain caused by surgery or childbirth, and to sedate patients before surgery or medical procedures. Promethazine injection is usually given when a person cannot take the medication orally (by mouth). Promethazine hydrochloride is available in generic form.
Promethazine hydrochloride suppositories (Brand Names: Phenadoz, Promethegan) is a phenothiazine that works by changing the actions of chemicals in your brain, and also acts as an antihistamine, used to treat allergy symptoms such as itching, runny nose, sneezing, itchy or watery eyes, hives, and itchy skin rashes. Promethazine hydrochloride suppositories is also used to prevent motion sickness, treat nausea and vomiting or pain after surgery, and as a sedative or sleep aid. Promethazine hydrochloride suppositories are available in generic form. Common side effects of promethazine hydrochloride suppositories include dizziness, drowsiness, sleepiness, restlessness, blurred vision, dry mouth, stuffy nose, ringing in the ears, weight gain, swelling in hands or feet, impotence, trouble having an orgasm, or constipation.
Promethazine hydrochloride COA
Product name | promethazine hydrochloride | |||
CAS No. | 58-33-3 | Outer Packing | 25KG/DRUM | |
Production date | APRIL 2016 | Shelf life | MARCH 2021 | |
Standard adopted | IP | |||
Items of analysis | Specification | Results | ||
description | a white or faintly yellowish,crystalline powder | a white crystalline powder | ||
solubility | very soluble in water,freely soluble in chloroform and in ethanol(95%) | very soluble in water,freely soluble in chloroform and in ethanol(95%) | ||
A. IR absorption spectrum | positions and relative sizes of the banks in the spectrum | positions and relative sizes of the bands in the spectrum | ||
B.by TLC | It complies with the identification test for phenothiazines | it complies with the identification test for phenothiazine | ||
C.Test with nitric acid | forms orange colored solution and organge-red precipitate | complies with test for chlorides | ||
pH(10% w/v solution) | 4.0-5.0 | 4.31 | ||
isopromethazine | not more than 1.0% | less than 1.0% | ||
other impurity | not more than 0.5% | less than 0.5% | ||
sulphated ash | not more than 0.5% | 0.20% | ||
loss on drying at 105ºC | not more than 0.5% | 0.20% | ||
assay | 98.5-101%(on anhydrous basis) | 100.0% | ||
Conclusion | Qualified |
Product Name | Promethazine hydrochloride |
CAS | 58-33-3 |
MF | C17H21ClN2S |
MW | 320.88 |
EINECS | 200-375-2 |
Purity | 99% |
Appearance | White crystalline powder |
HS Code | 4010320000 |
Categories | Active Pharmaceutical Ingredients;Intermediates & Fine Chemicals;Pharmaceuticals ;Sulfur & Selenium Compounds;Histamine receptor;API;COLACE;Inhibitors |
Synonyms | 10-(2-dimethylamino-1-propyl)phenothiazine hydrochloride;PROMETHAZINE HCL;PROMETHAZINE HYDROCHLORIDE;PHENERGAN;10-(2-(dimethylamino)propyl)phenothiazinemonohydrochloride;10-(2-(dimethylamino)propyl)-phenothiazinmonohydrochloride;10-(2-dimethylaminopropyl)phenothiazinehydrochloride;10-(3-dimethylaminoisopropyl)phenothiazinehydrochloride |
What is Promethazine hydrochloride
Promethazine is a neuroleptic medication and first-generation antihistamine of the phenothiazine family. The drug has strong sedative and weak antipsychotic effects. It also reduces motion sickness and has antiemetic and anticholinergic properties (via its action on the dopamine receptor D2). In some countries it is prescribed for insomnia when benzodiazepines are contraindicated. It is available in many countries under many brand names. Promethazine was developed in the mid 1940s when a team of scientists from Rhône-Poulenc laboratories were able to synthesize it from phenothiazine and a diamine side chain of diphenhydramine
Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol.
Each tablet, for oral administration, contains 25 mg or 50 mg of promethazine hydrochloride. In addition each tablet contains the following inactive ingredients: dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid.
Promethazine Hydrochloride Tablets USP, 50 mg also contain anhydrous lactose.
Usage:
1)Antihistaminic, antiemetic, CNS depressant.
2.For the treatment of allergic disorders, and nausea/vomiting.
3)With aminophylline in the treatment of asthma.
4)For the treatment of allergic disorders, and nausea/vomiting.
5)Dubbed hibernation and injection for artificial hibernation.
Promethazine hydrochloride COA:
Test Items | Specification | Test Results |
Description | White crystalline powder | White crystalline powder |
Identification | IR , UV conform | Conform |
Loss on drying | ≤0.5ml | 0.21ml |
Residue on ignition | Not more than 0.2% | 0.06ml |
Iron | Not more than 0.005% | 0.0018% |
Heavy metals | Not more than 0.001% | 0.0006% |
Related substances |
Total: Not more than 1.0% Individual: Not more than 0.5% |
0.32% 0.14% |
E-isomer | Not more than 0.3% | 0.19% |
Organic volatile impurities | Conforms | Conforms |
Assay | 99.0~101.0% | 99.51% |
Conclusion | Conform with USP30 |
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