Beijing Infoark Co Ltd

 25KG/DRUM

Item

Specification

Characteristics

Yellow crystalline powder

Identification

a)      HPLC results

b)      TLC results

c)      Color reaction with sulfuric acid

d)      Color reaction with silver nitrate

PH

2.03.0

Specific optical rotation

-105-120 Deg.

Specific absorbance at 349nm

300-335

Light-absorbing impurities 490nm

0.07 max

Related substances

a)      Methacycline: 2.0% max

b)      6-epidoxycycline: 2.0% max

c)      4-epidoxycycline: 0.5% max

d)      4-epi-6-epidoxycycline: 0.5% max

e)      Oxytetracycline: 0.5% max

f)        2-acetyl-2-decarbamoyldoxycycline: 0.5% max

g)      Any other impurity: 0.5% max

h)      Not indentified impurities:0.1%max

Ethanol

4.36.0%

Heavy metals

40ppm max

Water

1.42.8%Sulphate ash

0.4% maxAssay

95.0%102.0% (C22H25ClN2O8) 88.0%~94.0%( C22H24N2O8) basedon anhydrous, ethanol-free substance

test items

specifications

test results

CHARACTERISTICS

A WHITE OR ALMOST CRYSTALLINE POWDER

CONFORM

IDENTIFICATION

SHOULD MEET TELATED REQUIREMENTS

CONFORM

APPEARANCE OF SOLUTION

SHOULD MEET TELATED REQUIREMENTS

CONFORM

PH

3.5-5.5

4.5

SPECIFIC OPTICAL ROTATION

+135°- +150°

+142°

LINCOMYCIN B

NOT MORE THAN 5.0%

2.7%

HEAVY METALS

NOT MORE THAN 5PPM

CONFORM

WATER

3.1%-4.6%

4.2%

RESIDUE ON IGNITION

NOT MORE THAN 0.5%

0.1%

BACTERIAL ENDOTOXIN

LESS than 0.5IU/MG

<0.5IU/MG

ASSAY

NOT LESS THAN 89.5%, not more than 102.0% OF LINCOMYCIN (C18H35CLN2O6S)

99.2%

25KG/DRUM