Description

(S)-Cetirizine Dihydrochloride is the pharmacologically active enantiomer of the widely used second-generation antihistamine, cetirizine. This high-purity active pharmaceutical ingredient (API) is critical for developing enantiomerically pure formulations, offering enhanced therapeutic specificity and potentially reduced side-effect profiles. It is primarily required by pharmaceutical manufacturers and research institutions for the production of advanced antihistamine medications and for analytical reference standards.

Application

• Active Pharmaceutical Ingredient (API): Core component in the manufacture of enantiomerically pure antihistamine tablets, capsules, and oral solutions.
• Pharmaceutical R&D: Used in preclinical and clinical studies to investigate the specific pharmacokinetics and pharmacodynamics of the (S)-enantiomer.
• Reference Standard: Serves as a high-purity certified reference material (CRM) for quality control and analytical method development in pharmaceutical laboratories.
• Formulation Development: Employed in creating novel drug delivery systems, such as sustained-release or fast-dissolving formulations.
• Generic Drug Manufacturing: Essential for companies producing bioequivalent versions of patented enantiopure cetirizine medications.
• Metabolite Studies: Used in research to study the metabolic pathways and excretion profiles of the specific enantiomer.

Basic Information

Item	Detail
Product Name	(S)-Cetirizine Dihydrochloride
CAS No.	163837-48-7
Molecular Formula	C21H27Cl3N2O3
Molecular Weight	461.81 g/mol
Synonyms	(S)-Cetirizine 2HCl; Levocetirizine Dihydrochloride; (2-{4-[(R)-(4-Chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)acetic acid dihydrochloride; (S)-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride; R-Cetirizine Dihydrochloride; XYZAL® API (enantiomer); UNII-6U5EA9RT2O
EINECS	Contact for details

Quality Control

Our (S)-Cetirizine Dihydrochloride is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and enantiomeric excess, aligning with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and chiral purity is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Enantiomeric Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Water (KF Titration)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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