Product Name

Ibuprofen(75Grade)

Batch No.

20231020

MFG. Date

2023.10.20

Testing Date

2023.10.20

Retest Date

2023.10.20

Standard

USP36

ITEMS

SPECIFICATIONS

RESULTS

Characteristics

White crystalline powder

Conforms

Solubility

Practically insoluble in water ;very soluble in alcohol , in methanol ,in acetone, and in chloroform; slightly soluble in ethyl acetate

Conforms

Identification

AIR

B.UV

C.HPLC

a. Sample IR spectrum corresponds to that of the standard

Conforms

B. Sample UV spectrum does not differ from that of the standard by more than 3.0%

Conforms

C. Retention time corresponds to that of the standard

Conforms

Water Content

not more than1.0%

0.12%

Heavy Metals

not more than0.002%

＜0.002%

Residual on Ignition

not more than0.5%

0.02%

Chromatographic Purity

2-[3-(2-methylpropyl)phenyl]propanic acid :not more than0.15%

0.03%

2-[4-methyl phenyl]propanic acid :not more than0.15%

0.0%

2-[4-ethyl phenyl]propanic acid :not more than0.15%

0.01%

2-[4-propylphenyl]propanic acid :not more than0.15%

0.01%

2-[4-butylphenyl]propanic acid :not more than0.1%

0.0%

Any unknown impurities not more than 0.05%

0.02%

Total impurities :not more than 0.6%

0.07%

4-Isobutylacetophenone

Not more than 0.1%

0.0%

Assay(dried basis)

97.0%-103.0%

100.1%

ADDITIONAL TESTS

Residual solvents

(Petroleum ether)

Not more than 250ppm

79ppm

Bulk Density

0.25-0.50g/ml

0.43g/ml

Tapped density

0.50-0.75g/ml

0.64g/ml

Median particle size

60-90um

89.84um

Conclusion

The product meets USP36 specifications