White Azithromycin, Form : Neat, Neat

TESTING

SPECIFICATION

RESULT

Characteristics

(IP/EP)

It is white almost white powder

White Powder

Solubility

(EP/IP/USP)

Practically insoluble in water solubility anhydrous ethanol and

Confirms

Specific Rotation EP/IP/USP

-        45ᵒ ~ -49ᵒ

-        48ᵒ

Identification    IR 

IR spectrum should meet the requirement

Confirms

                           HPLC

LC chromatogram should meet the requirement

Confirms

Alkalinity    EP/IP/USP

9.0~11.0

9.9

Solution clarity and color IP/EP

Should be clear and colorless

Confirms

Crystallinity (USP)

Birefringence and extinction Positions

Confirms

Water      EP/IP/USP

4.0% ~ 5.0%

4.5%

Residue on ignition   IP/USP

≤ 0.2%

0.1%

Heavy metal (IP)

≤ 10 ppm

Confirms

Residual Solvents

Benzene

≤ 0.0002%

Not Detected

Methyl benzene

≤ 0.089%

0.0003%

Triethyl amine

≤ 0.032%

0.0001%

HPLC   Assay    USP

C₃₈H₂₂N₂O₁₂

945 – 1030 g/ml

988/mg