APIS Dexibuprofen S-Ibuprofen CAS 51146-56-6

Test  Item

Analysis  Specification

Result

Description

White crystalline power

white crystalline power

Identification

A: IR the spectrum is concordant with the spectrum of (S)-ibuprofen RS

B: The retention time of the principal peak is concordant with that of (S)-ibuprofen RS(HPLC)

C: Show two maximum absorption at 265nm and 273nm, two minimum absorption at 245nm and 271nm and a shoulder peak at 259nm.(UV)

Conforms

Conforms

Conforms

Melting point

50~54°C

50.8~52.7°C

Optical rotation

+55°~ +60°

+58.2°

Chloride

≤0.01%

<0.1%

Loss on drying

≤0.5%

0.02%

Residue on ignition

≤0.1%

0.01%

Heavy metals

≤10ppm

<10ppm

Residual solvents

Toluene not more than 800 ppm

3ppm

Related Substances

2-(4-butylphenyl)propionic acid  <0.2%

4-isobutylacetophenone        <0.2%

Total impurities             <0.7%

Any other individual impurity   <0.2%

Any unidentified impurity       <0.10%

R-ibuprofen                ≤1.5% 

       Not detected

Not detected

0.03%

0.02%

Not detected

Conforms

Assay(Dry Basis)

98.5%~101.0%

99.2%

Conclusion

Conform  to  In house Standard