Product Name

Roxithromycin

Specification

25kg/Drum

Batch No

100321

Batch Quantity

250kg

Production. Date

March 13, 2010

Report Date

March 24,2010

Expiry Date

March 10,2013

Testing Basis

BP2002

Items

Requirements

Results

Appearance

A white or almost white crystalline powder

A white crystalline powder

Specific rotation

-82°~-87°

-85.8°

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

4.2

Alkalinity pH

8.0~10.0

9.0

Water

less  than 3.0%

2.8%

Residue on ignition

less than 0.1%

0.06%

Heavy metals

less than 10ppm

less than 10ppm

on the anhydrous basis

more than 94.0%

95.9%

Conclusion

The material conform with  BP2002