CERTIFICATE OF ANALYSIS

                               Name of product:Metronidazole                 Batch weight:1000KGS

Packing :in 25kg/drum

Characteristics: a white or yellowish crystalline powder, slightly solube in water, in acetone, in alcohol and in methylene, chloride, very slightly solube in ether.

  Storage: store in a well-closed container, protected from light.

RESULT OF ANALYSIS

ITEMS

STANDARDS

RESULTS

Identification

A:IR

B:UV

COMPLY

Meltion point

159-163°C

160.3-160.6°C

Loss on drying

0.5% MAX

0.19%

Residue on igniton

0.1% MAX

0.04%

Appearance of solution

SUSPENSIONⅡ

AND SOLUTION GY6

COMPLY

Tapped density

≥0.7

Complies

Heavy Metal

20PPM MAX

<20PPM

Microorganism test

Total barcterium<1000UFC/G

Fungi and Mould<100UFC/G

COMPLY

BACTERIAL

ENDOTOXINS(EU/mg)

NOT MORE THAN 0.35

COMPLIES

Related substances

Impurity:0.1MAX

Total impurity:0.2MAX

0.054%

0.090%

Particle size

40-80MESH

COMPLY

Specific absorbance

365-395

376

Assay

99.0%-101.0% C₆H₉N₃O₃

99.62%C₆H₉N₃O₃

Conclusion: comply with the requirement of EP6 standard.

Director:                               Inspector: