Product Name

Ampicillin sodium

Batch No.

22101207

Quantity

300kg

MFG. Date

2022.10.12

Exp. Date

2024.09

Specification

BP2010

ITEMS

SPECIFICATIONS

RESULTS

Characters

A White or almost white powder

A white powder

Identification

Conforms

Conforms

Appearance of solution

≤2

0.25

Absorbance(430nm)

≤0.15

0.005

PH

8.0~10.0

8.92

Specific optical rotation

+258°~287°

+281.7°

Ampicillin dimer

≤4.5%

3.16

Other maximum individual impurity

≤2.0%

0.35%

2-Ethylhexanoic aicd

≤0.8%

N.D.

Methylene chloride

≤0.2

0.03%

Heavy metals

≤20ppm

Conforms

Water

≤2.0%

0.78%

Sterility

Conforms

Conforms

Bacteria endotoxins

Conforms

Conforms

Assay (C₁₆H18N3NaO4S)

89.0%~102.0%

96.06%

Conclusion

COMPLIES WITH BP2010