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TERFENADINE USP 23/BP2000

 

CAS NO- (50679-08-8)

FORMULA-C32H41NO2

 

Antialergic


Characteristics 

 

Sr.No

  

Tests

Specifications

Results

01

 

Description

White to almost-white powder.

 

White powder

 

02

Identification

a)      Melting Point :-145 0C to 1500 C

1490 C

b)      IR :- Similar to Standard

 

Complies

 

c)      Specific absorbance 13.5 to 14.9

14.3

d)      TlC :- Similar to standard

Complies

03

 

Loss on drying

(Moisture)

 

NMT  0.5%

 

0.256%

04

Specific rotation

(absorption)

Between : 190 to 210

 19.510

05

Total related Substances (liquid-Chromatograph/HPLC )

a)      Individual impurities NMT 0.5 %

 

b)Total Impurities:-NMT 0.5%

Nil

 

 

NIL

06

Heavy Metals

NMT 20 PPM

< 20 PPM

07

Sulphated Ash

NMT 0.1%

0.0593 %

08

Assay

(on dried basis)

Between 98.5% and 101%

99.528%