Product Name：

Metronidazole Benzoate

Packing：

25kg/drum

Batch No.：

0211705014

Manufacturing Date：

2017-05-14

Batch Quantity：

1000 kg

Test Date：

2017-05-18

Storage

Stored in closed container and protected from light

Expire Date：

2021.04

Test Specification： EP8.0 Specification

Test Items

Acceptance criteria

Tested Results

Appearance

white or slightly yellowish, crystalline powder or flakes.

Slightly yellowish crystalline powder

Identification

Melting point(℃)

UV

IR

Reaction  of  primary  aromatic amines

99～102

The solution shows an absorption maximum at 232nm and 275nm. The specific absorption at the 232nm is 525 to 575.

The sample spectrum complies with that of the reference standard spectrum.

The sample solution gives the reaction of primary

aromatic amines.

100.8～100.9

Maximum absorption are at 276 nm and 232 nm

Specific absorption is 550 Conforms

Conforms

Appearance of solution

The solution is not more opalescent than reference suspensions II.

The solution is not more intensely coloured than

reference solution GY3.

Conforms

Conforms

Acidity(ml)

≤0.25

0.19

Related Substances (HPLC)

Impurity A Impurity B Impurity C

Any other impurity,%

Total Impurities,%

≤0.1

≤0.1

≤0.1

≤0.1

≤0.2

N.D

N.D

N.D 0.06

0.10

Residual Solvents (GC)

Ethanol,% Toluene,%

Pyridine,%

≤5000

≤890

≤200

242

N.D

N.D

Heavy metals(ppm)

≤20

Conforms

Loss on drying(%)

≤0.5

0.2

Sulphated ash(%)

≤0.1

0.04

Assay (calculated on the dried substance),%

98.5～101.0

100.0