Description

Levocetirizine Impurity 4 is a designated impurity of the antihistamine drug Levocetirizine, identified by the CAS registry number 70558-10-0. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Levocetirizine active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Levocetirizine to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Levocetirizine Impurity 4
CAS No.	70558-10-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Levocetirizine Related Compound 4; (2-[4-[(R)-(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy)acetic Acid Impurity 4; Cetirizine Impurity; Levocetirizine EP Impurity D; UCB 28557 Impurity; (R)-Cetirizine Impurity; 2-(2-(4-((R)-(4-Chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic Acid Related Substance
EINECS	Contact for details

Quality Control

Our Levocetirizine Impurity 4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, spectroscopic identification (IR, NMR, MS), and determination of residual solvents to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data and traceability are provided and can be tailored to support regulatory filings.

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. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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