Model Number

NON-STERILE, FEED GRADE

COMMODITY: PENICILLIN G PROCAINE (NON-STERILE, FEED GRADE)

MANUFACTURE DATE: NOV. 11, 2008

EXPIRY DATE: OCT., 2011

ITEMS             SPECIFICATION            RESULTS

CHARACTERS:          A WHITE OR ALMOST WHITE MICRONIZED,      A WHITE MICRONIZED,

                     CRYSTALLINE POWDER                       CRYSTALLINE POWDER

 

IDENTIFICATION (IR):  IR SPECTRUM COMPLIES WITH THAT OF       COMPLIES WITH THAT OF

                      REFERENCE STANDARD                      REFERENCE STANDARD

PH (50MG/15ML H2O):                5.0-7.5                           5.8

WATER (KARL FISCHER):              2.8-4.2%                          3.4%

SPECIFIC OPTICAL ROTATION:      +165°-  +180°                      +173°

           (CALCULATED WITH REFERENCE TO THE ANHYDROUS SUBSTANCE)

RELATED SUBSTANCES:  THE AREA OF ANY PEAK CORRESPONDING TO

4-AMINOBENZOIC ACID IS NOT GREATER THAN

THE AREA OF THE CORRESPONDING PEAK IN

THE CHROMATOGRAM OBTAINED WITH REFERENCE

SOLUTION (0.024 PER CENT); THE AREA OF ANY

PEAK, APART FROM THE 2 PRINCIPAL PEAKS AND

ANY PEAK CORRESPONDING TO 4-AMINOBENZOIC

ACID,IS NOT GREATER THAN THE AREA OF THE

PEAK CORRESPONDING TO BENZYLPENICILLIN IN

THE CHROMATOGRAM OBTAINED WITH REFERENCE

SOLUTION (1 PERCENT)

PROCAINE:                           39.0-42.0%                        41.1%

(HPLC)      (CALCULATED WITH REFERENCE TO THE ANHYDROUS SUBSTANCE)

PROCAINE BENZYLPENICILLIN:          96.0-102.0%                       100.0%

(HPLC)      (CALCULATED WITH REFERENCE TO THE ANHYDROUS SUBSTANCE)

 

 

CONCLUSION: COMPLIES WITH PH. EUR. 6^TH EDITION STANDARDS