Name of product

Ethambutol HCl

Batch No.

20230312

Quantity

1000kgs

Manufacture date

2023/03/12

Expiry date

2026/03/11

Test standard

USP35

Test Items

Standard

Result

Characters

A white crystalline powder with moisture absorbency,

Odorless or almost odorless.

conforms

Identification

conforms

conforms

Specific rotation

+6.0°- +6.7°

+6.3°

Loss on drying

≤0.5%

0.2%

Heavy metals

≤20ppm

＜20ppm

Limit ofaminobutanol

≤1.0%

＜1.0%

Ordinary impurities

conforms

conforms

Assay

98.0%-100.5%

99.5%

Conclusion

The results conform with USP35 standard