NEBIVOLOL HYDROCHLORIDE. IN HOUSE
Tests
Specifications
1 Description
White to off white crystalline power
2 Identification:
1) IR spectrum
2) UV spectrum
3) Fluoride
4) HPLC
Positive
Positive
Positive
Positive
3 PH
4.5 to 6.5
4 Related substances:
NMT 1.0%
5 Loss on drying
NMT 0.5% w/w
6 Residue on ignition
NMT 0.1%
7 Heavy metals (ppm)
NMT 10ppm
8 Ethanol (%)
NMT 0.5%
9 Methylene Chloride
NMT 0.06%
10 Toluene
NMT 0.089%
11 Dimethylsulfoxide
NMT 0.088%
12 Assay(On dried basis)
It should contain not less than 98.0% & not more than 102% of the C22H26O4NCIF2 calculated on dried basis.