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HEPARIN SODIUM INJECTABLE GRADE

ITEMS

STANDARD

Origin

Porcine intestinal mucosa

Description

White or off-white powder

Solubility

40%

Odor

Odorless

Identification

A: Reaction of sodium
B: Specific optical rotation: NLT +35°

Turbidity of solution

640 nm: max. 0.018

Color of solution

Colorless

pH

5.5 to 8.0

Light absorption

260 nm: max. 0.100
280 nm: max. 0.100
400 nm: max. 0.020
420 nm: max. 0.018
470 nm: max. 0.015

Nitrogen

1.3% to 2.5%

Sodium content

9.5% to 12.5%

Sulphur

NLT 10.0%

Heavy metals

Max. 30 ppm

Loss on drying

NMT 5.0%

Residur on ignition

28.0% to 41%

Bacterial endotoxin

NMT 0.03 IU/USP U of heparin

Microbial purity

Bacteria: < 10CFU/g
Mold: Without
Germs: Without

Potency

NLT 150 USP u/mg



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