Baclofen NEW

Mfg Date:

2022-01-10

Exp.       Date:

2024-01-09

Standard:

USP43

Test Date:

2022-01-19

Batch No.:

YX220201005

Quantity

100kg

Items

Specifications

Results

Appearance

White or almost   white powder

White powder

Identification

The infrared   absorption spectrophotometry of the test preparation corresponds to that in   the chromatogram of the reference preparation.

Complies

The retention   time of the sample solution corresponds to that of the standard solution, as   obtained in the assay.

Complies

Organic   Impurities

HPLC

Impurity   A≤1.0%(Relative  retention time 2.3)

0.1%

individual   unspecified Impurity ≤0.10%

0.11%

Total impurity   ≤2.0%

0.3%

Water

≤3.0%

0.3%

Residue on   ignition

≤0.3%

0.1%

Heavy metal

≤10ppm

Complies

Residual   Solvents

≤0.5%

0.13%

Assay

98.0~102.0%

(calculated on   the anhydrous basis)

99.6%

Conclusion:   The product conforms to the USP43 standard.