Levocetirizine Dihydrochloride is the dihydrochloride salt of levocetirizine, a selective second-generation antihistamine used for the management of allergic conditions. It is the active R-enantiomer of cetirizine and exhibits high affinity for peripheral histamine H1 receptors.
Levocetirizine Dihydrochloride works by selectively blocking the action of histamine at peripheral H1 receptors. Histamine is an important mediator of allergic responses and contributes to symptoms such as sneezing, itching, rhinorrhea and urticaria. By inhibiting H1-receptor-mediated signaling, levocetirizine helps reduce these symptoms.
Levocetirizine Dihydrochloride is a synthetic small-molecule pharmaceutical compound with the molecular formula C21H27Cl3N2O3 and a molecular weight of approximately 461.81 g/mol. Its CAS Number is 130018-77-8.
The compound is supplied as the dihydrochloride salt of levocetirizine and is used in pharmaceutical formulations including tablets, oral solutions and other appropriate dosage forms.
Levocetirizine is a selective antagonist of peripheral histamine H1 receptors.
During an allergic response, histamine binds to H1 receptors and contributes to vasodilation, increased vascular permeability, sensory nerve stimulation and other allergic symptoms. Levocetirizine blocks this receptor activity, thereby reducing histamine-mediated symptoms.
Levocetirizine Dihydrochloride is used in the treatment of allergic rhinitis and chronic idiopathic urticaria. It can help relieve symptoms including sneezing, nasal discharge, nasal itching, ocular symptoms and skin itching associated with allergic reactions.
Levocetirizine Dihydrochloride API can be evaluated using validated analytical procedures for identification, assay, related substances, enantiomeric purity, water content, residual solvents, elemental impurities and other applicable quality attributes.
HPLC and suitable chromatographic and spectroscopic techniques may be used for identification, assay and purity determination. Control of the opposite enantiomer and related substances is particularly relevant because Levocetirizine is a stereochemically defined active pharmaceutical ingredient.
Acceptance criteria should be based on the applicable manufacturer's drug-substance specification, Certificate of Analysis and relevant pharmacopoeial and regulatory requirements.
Levocetirizine Dihydrochloride should be stored in a tightly closed pharmaceutical-grade container under controlled storage conditions. The material should be protected from excessive heat, moisture and direct light.
Specific storage requirements should follow the applicable manufacturer's approved specification.
Levocetirizine Dihydrochloride API may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Levocetirizine Dihydrochloride API is available for qualified pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory standards. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 1.0% |