Description

Cetirizine Impurity D Dihydrochloride is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a key specified impurity for the validation of analytical methods and the monitoring of manufacturing processes for the antihistamine drug Cetirizine. It is essential for laboratories in the pharmaceutical and contract research organization (CRO) sectors requiring precise impurity profiling to ensure drug safety and regulatory compliance. The availability of this well-characterized impurity standard supports the development and quality assurance of generic and innovator pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cetirizine Impurity D in active pharmaceutical ingredient (API) and finished drug product testing.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to separate and accurately measure impurity levels.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Cetirizine drug substances and products meet pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to monitor the formation of degradation products in Cetirizine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs/ANDAs) to demonstrate control over impurities.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthetic routes for Cetirizine.

Basic Information

Product Name	Cetirizine Impurity D Dihydrochloride
CAS No.	856841-95-7
Molecular Formula	C21H27Cl2N3O3
Molecular Weight	464.37 g/mol
Synonyms	Cetirizine Related Compound D; (RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid dihydrochloride; 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride; Cetirizine EP Impurity D; Cetirizine USP Impurity D; Zyrtec Impurity D Dihydrochloride; Levocetirizine Impurity D Dihydrochloride (non-specific)
EINECS	Contact for details

Quality Control

Every batch of Cetirizine Impurity D Dihydrochloride is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0% (on anhydrous basis)
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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