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SPECIFICATION OF OXYCLOZANIDE BP (VET)

Technical Details

Structure

Chemical Name

3, 3’, 5,5’, 6-pentachloro - 2’ - hydroxy - salicylanilide

Molecular Formula

C13H6Cl5NO3

Molecular Weight

401.46

CAS No.

2277-92-1

Action and use

Anthelmintic (Flukicide)

Preparation

Oxyclozanide Oral Suspension

Content

99.0 per cent to 101.0 per cent (dried substance).

Reference

BP-2009



Sr. No.

Test

Specification

1.

Description

Pale cream to cream-coloured powder

2.

Solubility

Freely soluble in acetone; soluble in ethanol (95%); slightly soluble in dichloromethane; very slightly soluble in water

3.

Identification

A: The IR absorption spectrum, Appendix II A, is concordant with the reference spectrum of   Oxyclozanide (RSV 33)
B: The light absorption, Appendix II B. in the range 250 to 350 nm of a 0.003% w/v acidified methanol exhibits a maximum only at about 300 nm; absorbance at about 300 nm, about 0.76, Appendix II B
C: Melts between 208oC to 211oC

4.

Ionisable Chloride

Not more than 1.4 ml is required (0.25%) in 2 gm

5.

Related substance by HPLC

i) Total Impurities before principle peak is Not more than 0.3%

ii) Total impurities after principle peak is not more than 1.0%

6.

Sulphated Ash

Not more than 0.2%

7.

Loss on Drying

Not more than 1.0%

8

Assay on dried basis, w/w

It should be not less than 98.0% and not more than 101.0 %