Description

Meclizine Dihydrochloride Monohydrate is a high-purity pharmaceutical active ingredient, a salt form of the well-known antihistamine and antiemetic agent. This compound is critical for ensuring the efficacy, stability, and precise dosing of finished pharmaceutical formulations. It is primarily required by manufacturers in the pharmaceutical industry for the production of anti-vertigo and anti-nausea medications.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of prescription and over-the-counter (OTC) medications for motion sickness and vertigo.
• Tablet Manufacturing: Direct compression or granulation processes for oral solid dosage forms.
• Capsule Filling: Used as the core API in both hard and soft gelatin capsules.
• Research & Development (R&D): Serves as a reference standard and starting material in pharmacological and pharmacokinetic studies.
• Veterinary Pharmaceuticals: Formulation of antiemetic treatments for animals.
• Clinical Trial Material (CTM): Supply of GMP-grade material for use in human clinical trials for new drug applications.

Basic Information

Product Name	Meclizine Dihydrochloride Monohydrate
CAS No.	31884-77-2
Molecular Formula	C25H27ClN2·2HCl·H2O
Molecular Weight	481.88 g/mol
Synonyms	Meclizine HCl Monohydrate; Meclozine Dihydrochloride Monohydrate; 1-(4-Chlorobenzhydryl)-4-(3-methylbenzyl)piperazine Dihydrochloride Monohydrate; Postafen; Bonine; Antivert; Itinerol; Calmonal; Histametizyne; CAS 31884-77-2
EINECS	Contact for details

Quality Control

Our Meclizine Dihydrochloride Monohydrate is manufactured under strict quality management systems. It is typically tested to meet high-purity standards suitable for pharmaceutical applications, with specifications aligning with major pharmacopoeial guidelines. Certificates of Analysis (COA) documenting identity, purity, and impurity profiles are available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	3.0% - 4.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%

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