Azithromycin I.p.

As a reputed firm, we are engaged in manufacturing, supplying as well as exporting a wide range of Azithromycin I.P. Kheda, Gujarat, India.

TEST:-
* Description
* Solubility
* Identification Test(s)
* Appearance of solution
* pH
* Specific Optical Rotation
* Water
* Sulphated Ash
* Heavy Metals
* Related Substances (by HPLC)
* Assay Tolerance : (OAB)

OBSERVATIONS:-
* White Powder
* Complies
* Complies
* Complies
* Complies
* Complies
* 8.8
* a -46A
* 5.2%
* 0.06%
* Complies
* Complies
* 98.1%

SPECIFICATIONS:-
* A white or almost white powder
* Practically insoluble in water
* Freely soluble in anhydrous ethanol & in methylene chloride
* A. By IR
* B. Retention time of the principal peak obtained with the test solution and reference solution corresponds to each other.
* Solution A is Clear
* 9.0 to 11.0
* a -45A to -49A
* 1.8 % to 6.5 %
* NMT 0.2 %
* NMT 25 ppm
* As per IP
* 96% to 102%
Azithromycin U.S.P.

TEST

Description
Solubility
Identification Test(s)
Appearance of solution
pH
Specific Optical Rotation
Water
Residue on Ignition
Heavy Metals
Related Substances (by HPLC)
Assay(OAB)

OBSERVATIONS

White Powder
Complies
Complies
Complies
Complies
Complies
8.8
a -46A
5.20%
0.06%
Complies
Complies
969.1Aug

SPECIFICATIONS
A white or almost white powder
Practically insoluble in water
Freely soluble in anhydrous ethanol & in methylene chloride
A. By IR