Cetirizine Di Hydrochloride Ip - White Powder, Assay 99.86%, Solubility In Water, Ph 1.57, Loss On Drying 0.26% W/w, Heavy Metals <10 Ppm

1.DescriptionWhite or almost white powderWhite powder
2.SolubilityFreely soluble in water, practically insoluble in acetone and in methylene chlorideComplies
3.First identification by
1.IR
2.Reaction of chlorides
Should match with the standard
Should be complies
Complies
Complies
4.Second identification by
Ii. UV Observance
iv. TLCThe specific absorbance at maximum is
359 to 381
Should be complies
Complies
Complies
5.Appearance of solutionSolution S should be clear and not more than intensely colored than reference solution BY7Complies
6.pHBetween 1.2 to 1.81.57
7.Loss on DryingNMT: 0.50% w/w0.26
8.Heavy metalsNMT: 10 ppmLess than 10 ppm
9.Sulphated AshNMT: 0.2% w/w0.10
10.Assay (On dried basis)NLT:99.0% W/W AND
NMT: 100.5% W/W99.86
11.Related substances by HPLC
a. Any single impurity
b. Total impurity
NMT: 0.10%
NMT: 0.30%
0.07
0.24