Description

Levocetirizine is the pharmacologically active R-enantiomer of the second-generation antihistamine cetirizine. This high-purity active pharmaceutical ingredient (API) is valued for its potent and selective peripheral H1-receptor antagonism, offering enhanced efficacy with a favorable side-effect profile. It is essential for manufacturers in the global pharmaceutical industry developing advanced antihistamine medications for the treatment of allergic conditions such as rhinitis, chronic urticaria, and allergic conjunctivitis.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription and over-the-counter (OTC) antihistamine tablets, oral solutions, and orally disintegrating films.
• Allergy Medications: Formulation of drugs for the symptomatic relief of seasonal and perennial allergic rhinitis (hay fever).
• Antipruritic Treatments: Manufacture of medications for the management of skin allergies, including chronic idiopathic urticaria (hives) and associated itching.
• Pediatric Formulations: Development of age-appropriate, low-dose oral solutions for safe and effective allergy relief in children.
• Combination Therapies: Potential use in fixed-dose combination drugs with decongestants (e.g., pseudoephedrine) for comprehensive allergy symptom management.
• Generic Drug Production: Sourcing of API for cost-effective generic versions of branded levocetirizine products.

Basic Information

Product Name	Levocetirizine
CAS No.	130018-77-8
Molecular Formula	C21H25ClN2O3
Molecular Weight	388.89 g/mol
Synonyms	(R)-Cetirizine; Levocetirizine dihydrochloride; (2R)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid; Xyzal (brand name); R-cetirizine; (R)-(-)-Cetirizine; L-Cetirizine; Allercet (brand name)
EINECS	Contact for details

Quality Control

Our Levocetirizine is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards including USP and EP. Every batch undergoes comprehensive analytical testing to ensure identity, potency, and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting critical parameters such as assay, enantiomeric excess, and limits for specified impurities and residual solvents.

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 low-humidity environment to prevent moisture absorption and ensure long-term stability.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Enantiomeric Purity	≥ 99.5% (R-isomer)
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.2% Total impurities: ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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