Product Name

Benzylpenicillin Potassium Sterile

Batch No.

220574

MFG. Date

2022/05/26

Report Date

2022/06/12

Exp. Date

2024/05/25

Package

316Kg/bag

Quantity

220 bag

ITEMS

SPECIFICATIONS

RESULTS

Characters

White or almost white crystalline powder

White crystalline powder

Identification

Complies

Complies

Tests

PH

5.5-7.5

6.44

Specific optical rotation

+270°~ +300°

+295°

Absorbance

325nm

≤0.10

0.01

280nm

≤0.10

0.02

264nm

0.80-0.88

0.84

Related substances

≤1.0%

0.1%

Loss on drying

≤1.0%

0.09%

Sterility

Complies

Complies

Bacterial endoloxins

＜0.16IU/mg

Complies

Assay calculated as anhydrous substance

96.0%~102.0%

99.3%

Conclusion

Complies with EP 5th standard