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You are here -- Active Pharma Ingredients -- Indapamide

Indapamide

glipizide
CAS No. 26807–65–8
Chemical Name 4-chloro-N-[(2RS)-2-methyl-2,3-dihydro1Hindol-1-yl]- 3- sulphamoylbenzamide
Molecular Formula C16H16CIN3O3S
Molecular Weight 365.8
End Use Antidiabetic

Product Specifications

Description White or almost white powder.
Solubility Practically insoluble in water , soluble in alcohol ,acetonitrile, ethyl acetate
Identification

i) IR
ii )UV Absorption
To comply
To comply positively
( Absorption max. at 242nm , 279nm & 287 nm )
Melting Point Melts bet. 1670C -1700C
LOD (at 1050C 4hr.) NMT 3.0 %
Sulphated ash NMT 0.1 %
Chromatographic Purity by TLC 1. No secondary spot is more than 0.5%
2. The sum of the all secondary spots is NMT 2.0%
Residual organic solvents.
Isopropyl alcohol
Toluene
Acetone
(AS PER USP 31 SUPPLIMENT 2 JULY08)
NMT 1000 ppm
NMT 800 ppm
NMT 400 ppm
Related substance By HPLC Methylnitrosoindoline
Not more than 5 ppm
Indapamide impurity B
NMT 0.3%
Sum of all Impurities
NMT 0.5%
Assay by HPLC 98.0 % To 101.0 % w/w (ODB)