Products Name:

Secnidazole

Batch NO:

W201712F06

Batch Size:

1000.0kg

Date of Manufacture

Dec.27,2017

Date of Analysis:

Dec.31,2017

Report No:

YC2017-12-F06

Reference

In-house

Validity date

Dec.26,2020

Items

Acceptance criteria

Results

Character

Appearance

It is almost white or slightly yellowish crystalline powder

It’s slightly yellowish crystalline powder

solubility

Freely soluble in ethanol, Soluble in chloroform, sparingly in wart or ethyl ether ,freely soluble in dilute acid

conforms

Melting point

68.0℃~78.0℃

76.5℃ ~77.5℃

Identification

A.Chemical reaction:The solution to be examined gives positive chemical reactions.

The solution be examined gave positive chemical reaction

B.UV(water) Max 277nm, min 241 nm

conform

C.Infrared Absorption:The spectrum obtained with the substance to be examined corresponds to that of the reference standard of Secnidazole

The spectrum obtained withe the substance to be examined corresponded to that of the reference standard of Secnidazole

D.The absorbance ( E_cm^{1 percent}) of the solution(13ug/ml in hydrochloride(9---1000) should be 331-349 at 277nm)

344

Tests

Clarity and colour of solution

The solution is clear and colouredless

conforms

Acidity and Alkalinity

5.5~7.5

6.3

Loss on drying

4.0 percent to 6.0 percent

4.5 percent

Related substance(HPLC)

2-methyl-5-nitronimidazole:NMT0.5 percent

0.03 percent

Any other individual impurity: NMT 0.5 percrnt

0.08 percent

Total impurity:NMT1.0 percent

0.1 percent

Heavy metals

Not more than 0.001 percent

Less than 0.001 percent

Sulphated metals

Not more than 0.1 percent

Less than 0.1 percent

Residual solvent

Dichloromethane:NMT300PPM

No detected

Ethyl acetate:NMT1000ppm

No detected

Particle sizel

1000 percent less than 40 mesh

conforms

Assay

It contains not less than 98.5 percent of C₇H₁₁N₃O_3, calculated to the dried substance 

99.3 percent