NAME OF PRODUCT: BACITRACIN Zn  USP43

EXPIRY DATE: 3 YEARS

PACKING: 10KG/DRUM

ITEMS

STANDARD

APPEARANCE

WHITE OR GRAYISH YELLOW POWDER

IDENTIFICATION A

MEET THE REQUIREMENTS

IDENTIFICATION B

MEET THE REQUIREMENTS

PH

6.0~7.5

COMPOSITION

CONTENT OF BACITRACIN A

≥ 40.0%

SUM OF BACITRACIN A,B1,B2 AND B3

≥ 70.0%

SUM OF EARLY ELUTING PEPTIDES

≤ 20.0%

CONTENT OF BACITRACIN F

≤ 6.0%

IMPURITIES X3 RRT:0.94

≤15.0%

OTHER UNDETERMINED MAXIMUM IMPURITY

≤2.0%

ZINE CONTENT ON THE DRIED BASIS

4.0%~6.0%

LOSS ON DRYING

≤ 5.0%

N-BUTANOL

≤5000PPM

ASSAY ON THE DRIED BASIS

≥65U/MG

MICROBIAL LIMIT TEST

THE TOTAL NUMBER OF AEROBE

≤100CFU/G

TOTAL MOLDS AND YEASTS

≤10CFU/G

STAPHYLOCOCCUS AUREUS

NONE

PSEUDOMONAS AERUGINOSA

NONE

PARTICLE SIZE LT 20 MICRONS

100%