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Indapamide

CAS No. 26807–65–8
Chemical Name 4-chloro-N-[(2RS)-2-methyl-2,3-dihydro1Hindol-1-yl]- 3- sulphamoylbenzamide
Non propriety Names ------
Molecular Formula C16H16ClN3O3S
Molecular Weight 365.8

Product Specification

Description White or almost white powder.
Solubilit 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. 167 0 C-170 0 C
LOD (at 105 C 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)
Therapeutic Category of these Drugs :-  Diuretic, Antihypertensive