卡贝缩宫素CARBETOCIN

Test

Specification

Result

Test method

Reference No.

Appearance

White fluffy powder

White fluffy powder

PT/QC/CB/01-1

Solubility

soluble in water.

soluble in water.

PT/QC/CB/01-2

HPLC

The principal peak in the chromatogram obtained with the test solution is similar in retention time to principal peak in the chromatogram obtained with the reference solution.

Complies

PT/QC/CB/01-3

By Mass

MS scan spectrum, the

major peak in the

mass-to-charge ratioof 988.161 should be observed.

987.53

PT/QC/CB/01-4

Related Substances

Any individual impurity :

NMT 0.5%

Total impurity :

NMT 2.0%

0.22%(Single largest impurity)

0.28%

PT/QC/CB/01-5

Test

Specification

Result

Test method

Reference No.

Peptid content

NLT 84%

95.00%

PT/QC/CB/01-6

Acetic acid

NMT 6%

2.53%

PT/QC/CB/01-7

water

NMT 5%

2.50%

PT/QC/CB/01-8

Bacterial endoxins

Less than 5IU/mg

complies

PT/QC/CB/01-9

Assay

(anhydrous, acetic acid free substance )

95%-105%

100.30%

PT/QC/CB/01-10

Total viable count

NMT 100cfu/g

Less than 10cfu/g

PT/QC/CB/01-11

Specific Optical ration

-71 to -81

(C=0.5%; 1% acetic acid v/v)

-75.2

PT/QC/CB/01-12

Residual solvent

Methanol

Acetonitrile

Triethylamine

NMT 3000ppm

NMT 410 ppm

NMT 320 ppm

74ppm

40ppm

10 ppm

PT/QC/CB/01-13