Loratadine usp

	<< Back
Product Name	LORATADINE USP
IUPAC Name	Ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b] pyridine - 11-ylidene)-1-piperidinecarboxylate
C.A.S. No	79794-75-5
Molecular Formula	C22H23ClN2O2
Formula Weight	382.88
Therapeutic category	Allergy

SR. NO.	TEST	SPECIFICATION
1	Description	White to off white powder
2	Solubility	Freely soluble in acetone, in chloroform, in methanol and in toluene, insoluble in water
3	Identification: A. By IR B. By HPLC	A. The infrared absorption spectrum of the substance being examined in mineral oil should be concordant with the Infrared absorption spectrum obtained from Loratadine working standard. B. The retention time of the major peak in the chromatogram of the Assay Preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay
4	Melting range	Between 132°C and 137°C
5	Loss of drying (105oC/3 hrs.)	Not more than 0.5 % w/w
6	Residue on ignition	Not more than 0.1 % w/w
7	Heavy metals	Not more than 0.001 %
8	Related substances (By HPLC) (1) 4-(8-chloro-11-fluoro-6,11-dihydro- 5H -benzo[5,6] cyclohepta[1,2- b]pyridin-11-yl)-piperidinecarboxylate ethyl. (2) Unknown impurity (3) Total impurities	Not more than 0.2% Not more than 0.1 % Not more than 0.3 %
9	Assay (By HPLC)	98.5 % to 101.0 % of C22H23ClN2O2, calculated on the dried basis