Description

Promethazine Hydrochloride is a phenothiazine derivative with potent antihistaminic and sedative properties, making it a critical active pharmaceutical ingredient (API). It is essential for the formulation of medications that effectively manage allergic conditions, motion sickness, and provide pre-operative sedation. This compound is primarily required by pharmaceutical manufacturers, research institutions, and compounding pharmacies for the production of injectable solutions, syrups, and tablets.

Application

• Pharmaceutical API: Core ingredient in anti-allergy and antiemetic medications.
• Antihistamine Formulations: Used to treat symptoms of allergic reactions such as rhinitis, conjunctivitis, and skin rashes.
• Antiemetic Preparations: Effective in preventing and treating nausea and vomiting, particularly associated with motion sickness or post-operative recovery.
• Sedative Applications: Employed in pre-anesthetic medication to produce calming and drowsiness effects.
• Research & Development: Serves as a reference standard and key intermediate in pharmacological and clinical studies.
• Compounding Pharmacy: Used by specialized pharmacies to prepare customized dosage forms for specific patient needs.

Basic Information

Product Name	Promethazine Hydrochloride
CAS No.	58-33-3
Molecular Formula	C17H20N2S•HCl
Molecular Weight	320.88 g/mol
Synonyms	Promethazine HCl; 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride; (2RS)-N,N-Dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine hydrochloride; Phenergan; Atosil; Fargan; Lergigan; Prothazine; Histantil; Ganphen
EINECS	200-375-5

Quality Control

Our Promethazine Hydrochloride is manufactured under strict quality systems. Each batch is tested to ensure compliance with major pharmacopoeial standards such as USP, EP, and BP. We provide comprehensive Certificates of Analysis (COA) that detail purity, identity, and impurity profiles, ensuring traceability and reliability for your pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed and away from direct light exposure to maintain stability and potency.

Specification

Item	Specification
Appearance	White to faint yellow, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Conforms to standard
Assay (on dried basis)	98.5% - 101.0%
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Specific Rotation (if applicable)	- Contact for details -

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.