Product Name: Nirmatrelvir

Batch No: 148-B020-220101

CAS NO.：2628280-40-8

Batch Size: 8.4kg

Manufacturing Date: 2022.01.31

Test Date: 2022.02.03

Test Items

Acceptance Criteria

Results

Appearance

White to light yellow powder

Light yellow powder

Identification

The retention time of major peak in the chromatogram of test solution as obtained for assay should correspond to the standard solution.

Conforms

Any single  Impurity ≤0.10%

0.02%

Total Impurities

0.05%

Solvent Residual

Methyl tert-butyl ether

10ppm

Isopropyl acetate

1894ppm

N-heptane ≤ 5000ppm

570ppm

Residue on Ignition

≤ 0.20%

0.09%

Heavy Metals

≤ 20ppm

Conforms

Water

≤ 1. 0%

0.11%

Assay

98.0% ~ 102.0%  (on anhydrous basis)

99.5%

Conclusion

Conforms to Specifications