Levocetirizine Dihydrochloride Non Sedative Pharmaceutical Raw Materials Antihistamine

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Levocetirizine Dihydrochloride Quick Details

Nom du produit Levocetirizine Dihydrochloride
CAS No. 130018-87-0
EINECS No. 200-659-6
M.F. C21H27Cl3N2O3
M.W. 461.81
Apparence poudre blanche

 

Levocetirizine Dihydrochloride Description

Levocetirizine (Xyzal) is an antihistamine used for the treatment of allergic rhinitis (hay fever) and long term hives of unclear cause. It is less sedating than older antihistamines. It is taken by mouth.

It is classified as a second-generation antihistamine and works by blocking histamine H1-receptors.

 

Levocetirizine dihydrochloride Certificate of Analysis

Nom du produit Levocetirizine dihydrochloride
CAS No. 130018-87-0 Emballage externe DRUM
Date de production MAR 2018 Durée de conservation FEB 2022
Norme adoptée USP
Éléments d’analyse Spécification du Résultats
description a white or almost white powder white powder
solubility freely soluble in water complies
pH 1.2-1.8 1.42
identification
A.by IR to comply complies
B.by HPLC the retention time of the major peak of the sample solution corresponds to that of the levocetirizine peak in the system suitability solution as obtained in the test for enantiomeric purity complies
C.by test of chloride should respond to chloride complies
residue on ignition NMT 0.1% 0.06%
loss on drying NMT 0.50% 0.30%
enantiomeric purity(by HPLC) NMT 1.0% of the s-enantiomer 0.21%
organic impurities(by HPLC)
chlorobenzhydryl piperazine NMT 0.10% complies
levocetizine amide NMT 0.10% complies
any individual unspecified impurity NMT 0.10% complies
total impurities NMT 0.40% complies
assay(by HPLC) 98.0%-102%(calculated on the dried basis) 99.80%
Conclusion Qualifié

 

Levocetirizine Dihydrochloride Side Effects

Common side effects include sleepiness, dry mouth, cough, vomiting, and diarrhea. Use in pregnancy appears safe but has not been well studied and use when breastfeeding is of unclear safety.

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