Roxithromycin CAS NO.80214-83-1

Appearance

A white or almost white crystalline powder

A white crystalline powder

Specific rotation

-82°～-87°

-85.4°

Identification (IR)

(1)should be consistent for the trying solution prominent peak retention time with the comparison solution prominent peak retention time

Consistent

(2)this infrared light absorption atlas should be consistent with the comparison atlas

Consistent

related substance

The single impurity peak area does not have to be bigger than the comparison solution prominent peak area 1.5 times

0.9

Each miscellaneous quality area of with can not be big in check against aqua a lord the area of 4.5times

4.3

Alkalinity

8.0～10.0

9.0

Water

≤3.0%

2.7%

Residue on ignition

≤0.1%

0.06%

Heavy metals

≤10ppm

＜10ppm

(on the anhydrous basis)

≥94.0%

94.7%

Conclusion

The material conform with"Chinese Pharmacopoeia" in 2005 version two。