Norfloxacin

TEST

SPECIFICATION

RESULT

Description

White to pale yellow

Crystalline powder

Complies

Identification

IR:comparing with the spectrum obtained with norfloxacin CRS

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Appearance of solution

≤Sol.II

≤B₇

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Solubility

Slightly soluble in acetone and in

Ethanol(96 percent),

Very slightly in water

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Related

Substances

Impurity E

≤0.15%

Not detected

Impurity k

≤0.15%

0.06%

Unspecified Impurities

≤0.10%

0.02%

Total Impurities

≤0.5%

0.3%

Assay

99.0%－101.0%

99.8%

Loss on drying

≤1.0%

0.3%

Sulphated ash

≤0.1%

0.04%

Heavy metals

≤0.0015%

Complies

Residual solvents

Ethanol≤0.5%

Not detected

Microbial Iimits

Total of bacterie

≤1000cfu/g

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Yeast and mould

≤100cfu/g

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Eschericha coli

Undetected

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