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Glibenclamide Sulfonamide

CAS No. 16673-34-00
Chemical Name 5-chloro-2-methoxy-n- [2-(4sulfamoylphenyl) Ethyl]benzamide
Non propriety Names EBSA, Sulfonamide for Glibenclamide Pure
Molecular Formula C16H17ClN2O4S
Molecular Weight 368.83518

Product Specification

Description : White to yellowish crystalline powder
Melting Range : 2110C – 2160C
Appearance of Solution : 2.5 % solution in DMF is clear without any deposits
Chloride : NMT  0.2 %
L.O.D. : NMT  1.0 %
Assay By
UV Spectrophotometer
: 96.5 to 102.5 % w/w on Dried Basis
Related Substance TLC method
by HPLC
(for USV LTD only)
: 1) Ortho Isometer NMT  1 %
  2) Meta Isometer NMT  2 %
  3) Other imp. NMT  2 %
  4) Total imp. NMT  5 %
Optional : only to be tested befor USV dipatch
HPLC
(by Aventis method)
:By product single 0.5%
 impurity at 1.22<- 0.5%
 Sum of all byproducts <-1.0%
 Optional - Only to be tested before Aventis dispatch
It is used as an intermediate for the following drug :-
Glibenclamide (CAS No 10238-21-8)
Therapeutic Cat. Of This Drug :- Antidiabetic