99% High Purity and Top Quality Biapenem 120410-24-4

Test items

Enterprise specification

Test results

Appearance

White to light yellow crystal or crystalline powder, no odor

White crystalline powder, no odor

Specific rotation

-27°~-34°

-32°

Identification

1. Into 10mg of the substance to be examined, add 2ml of water for dissolving and 3ml of hydroxylamine hydrochloride solution, shake well, and allow to stand for 3min. Add 1ml of acid ferric ammonium sulfate, shake well, and then the solution shows red brown.

2. Add water to dilute 20mg of the substance to be examined to 100ml, accurately pipette 5ml, and dilute with water to 50ml, to obtain solution with concentration of 20ug/ml with water. The maximum absorption should exist at 293nm, and the minimum absorption should exist at 241nm.

3. In the chromatogram of the assay, the retention time of the major peak in the chromatogram obtained with the test solution corresponds to that of the major peak in the chromatogram obtained with reference solution.

4. The infrared spectrum of the substance to be examined corresponds to that of the reference spectrum.

1.Conform

2.Conform

3.Conform

4.Conform

Acidity (10mg/ml)

4.0~6.0

5.3

Clarity of solution (10mg/ml)

No more pronounced than that of reference suspension I

Less pronounced than that of reference suspension I

Color of solution (10mg/ml)

No more intensely colored than the reference solution Yellow No.2

Less intensely colored than the reference solution Yellow No.1

Related substances

The biggest individual impurity

No more than 0.5%

0.2%

Total impurity

No more than 1.0%

0.30%

Related substance A and related substance B

Total impurity no more than 0.5%

Not detected

Polymer

No more than 0.2%

0.05%

Loss on drying

No more than 0.5%

0.05%

Residue on ignition

No more than 0.1%

0.04%

Heavy metal

No more than 0.0010%

Less than 0.0010%

Bacterial endotoxin

No more than 0.5EU/mg

Less than 0.5EU/mg

Report No.: 0004

Batch No.: 1207004