Description

Hydroxyzine Acetic Acid Dihydrochloride is a key pharmaceutical intermediate and reference standard. This compound is critical for ensuring the quality, safety, and efficacy of final drug products derived from hydroxyzine. It is primarily utilized by research institutions, analytical laboratories, and manufacturers within the global pharmaceutical and fine chemical industries for synthesis, quality control, and regulatory compliance purposes.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of hydroxyzine-based active pharmaceutical ingredients (APIs).
• Analytical Reference Standard: Used for the qualitative and quantitative analysis (e.g., HPLC, LC-MS) of hydroxyzine in raw materials, finished products, and stability studies.
• Pharmacological Research: Serves as a precursor or standard in studies investigating the metabolism, pharmacokinetics, and mechanism of action of hydroxyzine.
• Quality Control & Assurance: Essential for method development, validation, and routine testing in pharmaceutical QC laboratories to verify identity, purity, and potency.
• Impurity Profiling: Used to identify and quantify related substances and degradation products in hydroxyzine drug substances and formulations.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing a characterized standard for analytical procedures.

Basic Information

Product Name	Hydroxyzine Acetic Acid Dihydrochloride
CAS No.	83881-56-5
Molecular Formula	C21H31Cl2N2O3
Molecular Weight	430.39 g/mol
Synonyms	2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride; Hydroxyzine Impurity A Dihydrochloride; Hydroxyzine Related Compound A Dihydrochloride; Hydroxyzine EP Impurity A Dihydrochloride; Hydroxyzine Acetate Dihydrochloride; 1-(p-Chloro-α-phenylbenzyl)-4-[2-(carboxymethoxy)ethyl]piperazine dihydrochloride
EINECS	Contact for details

Quality Control

Our Hydroxyzine Acetic Acid Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical research and development. Certificates of Analysis (COA) detailing identity, purity, and impurity profiles are provided with every shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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