High quality Clarithromycin

Product Name:

                          Clarithromycin Powder 

CAS No.:

81103-11-9

Quantity

25kg

Rep Date

Jun.29.2015

Batch NO.

Jun.29.2015

MFG. Date

Jun..29.2015

Expiry Date

Jun.29.2017

Items

Specifications

Results

Appearance

White to almost white crystalline powder

white crystalline powder

Solubility

Soluble in acetone;slightly soluble in dehydrated alcohol,in methanol,

and in acctonitrile,and in phosphate butter at PH values of 2 to5;

practically insoluble in water

Conforms

Identification

IR:conforms to the spectrum of clarithromycin RS

Conforms

Specific optical  rotation

-94.--102.(anhydrous substance,1

0mg/ml methylene chloride)

-98.

Sulphated ash

≤ 0.2%

<0.01%

Appearance of solution

Clear or not more opalescent than reference suspension II

 and not more intensely coloured than reference solutionY7 

Conforms

Crystallinity 

Meet the requirements

Conforms 

pH

8.0-10.0

8.7

Water 

≤ 2.0%

0.35%

Related substances

(1)any single impurity

≤ 1.0%

0.65%

(2)any impurities

 greater than 0.4%

not more than 4 impurities

1

(3)total impurities

≤ 3.5%

2.0%

Heavy metals

≤ 0.002%

2.0%

Residul solvents

     Ethanol ≤ 5000ppm

Not detected

Pyridine≤220ppm

Not detected

Assay (on dried basis )

96.0% ~ 102.0%(anhydrous substance)

97.3%

Conclusion

It complies with USP38 standard.