Description

Levocetirizine Amide Impurity Hcl CAS NO 909779-33-5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient levocetirizine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical impurity profiling and identification studies.
• Analytical method development and validation for levocetirizine hydrochloride.
• Quality control and batch release testing in API manufacturing.
• Stability studies to monitor degradation pathways.
• Calibration standard for HPLC, UPLC, and LC-MS systems.
• Reference material for regulatory submissions (e.g., FDA, EMA).
• Research and development of related antihistamine compounds.
• Teaching and academic research in pharmaceutical chemistry.

Basic Information

Product Name	Levocetirizine Amide Impurity Hcl
CAS No.	909779-33-5
Molecular Formula	C21H25ClN2O3 • HCl
Molecular Weight	425.35 g/mol
Synonyms	2-[2-[4-[(R)-(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetamide hydrochloride; (R)-Cetirizine Amide Impurity Hydrochloride; Levocetirizine Related Compound H; Levocetirizine EP Impurity H; Levocetirizine USP Impurity H; (R)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetamide monohydrochloride
EINECS	Contact for details

Quality Control

Our Levocetirizine Amide Impurity Hcl is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with every shipment, ensuring traceability and compliance with pharmaceutical reference standard requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 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.