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DOMINION VETERINARY LABORATORIES LTD

DOMINION VETERINARY LABORATORIES LTD.

QUALITY CONTROL DEPARTMENT

 

 

RAW MATERIAL ANALYSIS REPORT?b style='mso-bidi-font-weight:normal'>70R-CTETR

 

 

Chemical Name: CHLORTETRACYCLINE HCl???????? RM Control No.:__________

Supplier:___________________________?????????????? Qty. Received:____________

Lot No.:___________________________?????????????? Date Received:___________

Expiry Date:________________________

 

 

PARAMETERS

USP

SPECIFICATION

RESULT

REMARKS

 

Description

 

Yellow crystalline powder. Is odourless, and has a bitter taste. Is stable in air, but is slowly affected by light .

 

 

Solubility

 

Sparingly soluble in water; soluble in solutions of alkali hydroxides and carbonates; slightly soluble in alcohol; practically insoluble in acetone, in chloroform,?and in ether.

 

 

Identification

 

A: Method II under tetracyclines <193>

B: A solution (1 in 20) responds to tests for chlorides.

 

 

Specific rotation <781S>

Between ?35?and ?50?in water 5 mg per ml that has been allowed to stand in the dark for 30 minutes

 

 

Crystallinity <695>

Meets the requirements

 

 

pH

Between 2.3 and 3.3, in a solution containing 10 mg per mL.

 

 

Loss on drying <731>

It loses not more than 2.0% of its weight

 

 

Assay Microbial assays <81>

Not less than 820 ug per g

 

 

 

 

QC DISPOSITION:??[????? ] PASSED??????????????? [ ?????] REJECT

 

Analyzed by:_____________________??????????? Noted by:______________________

 

Date :___________________________?????????? Date :_________________________

 

 

Revised July, 2005 by GAM??????????????????? Approved By:__________________