Roxithromycin

Characters

White or almost   white crystalline powder; very slightly soluble in water, freely soluble in   acetone, in alcohol and in methylene chloride, it is slightly soluble in   dilute hydrochloric acid

Conforms

Appearance of   solution

(1)         IR:   conforms to the roxithromycin CRS spectrum

(2)         HPLC:   similar in retention time and size to the principal peak of the reference   solution

Conforms

Appearance of   solution

Clear and   colorless

Conforms

Specific optical   rotation

-93°~-96°

-94°

Related   substances by HPLC

Impurity G ≤1.0%

Impurities   A,B,C,D,E,F,H,I,J≤ 0.5%

Total impurities≤   3.0%

0.23%

0.34%

1.8%

Heavy metals

≤10ppm

＜10ppm

Water

≤3.0%

2.0%

Sulphated ash

≤0.1%

0.02%

Residual   solvents

Methanol   ≤3000ppm

206ppm

Assay (HPLC)

96.0%~102.0%

98.9%

Conclusion:   Conforms to EP9.0 specification for Roxithromycin.