• 中文
  • English

Welcome to the website of  CSBIO !

  • Home
  • News
  • About us
  • Culture
  • Products and R&D
    • API
    • Finished Products
    • Products under Registration
  • Human Resources
  • Contact us
Products and R&D
  • API
    • Heparin sodium
    • Low Molecular Weight Heparin Calcium
    • Dalteparin Sodium
    • Enoxaparin Sodium
    • Nadroparin Calcium
    • Levobupivacaine Hydrochloride
    • Slidenafil Citrate
  • Products under Registration
    • Dalteparin sodium injection
    • Enoxaparin sodium injection
    • Nadroparin calcium injection
    • Levobupivacaine hydrochloride injection

>
Home>>Products and R&D>>API
Nadroparin calcium
  • Introduction
  • Specification

 

Nadroparin calcium is a new kind of antithrombotic drug. It is obtained by depolymerization of heparin. The average molecular weight of nadroparin sodium is about 4300 Da. Nadroparin calcium has obvious anti-factor Xa activity and affects the clotting time to a less degree than heparin.

    Nadroparin calcium is mainly indicated for deep vein thrombosis, pulmonary embolism, hemodialysis, and unstable coronary artery disease (unstable angina and Non-Q-Wave myocardial infarction) and so on.


Test

Acceptance criteria

Origin

Porcine intestinal mucosa

Characters

White or almost white,hygroscopic powder

Identification

A:13C-NMR

B:the mass-average relative molecular mass ranges between 3600 and 5000, with a characteristic value of about 4300.

<2000: not more than 15%

2000~8000: 75.0%~95.0%

2000~4000: 35.0%~55.0%

Anti-factor Ⅹa activity

95 IU/mg~130 IU/mg

The ratio of Anti-factor Ⅹa / Anti-factor Ⅱa

2.5~4.0

Appearance of solution

Not more opalescent than reference suspensionⅡand not more intensely colored than reference solution Y5

pH

5.5~8.0

Ethanol

Not more than 0.5%(m/m)

N-NO groups

Not more than 0.25 ppm

Free sulfates

Not more than 0.5%

Nitrogen

1.5%~2.5%

Calcium

9.5%~11.5%

Nucleotide and protein impurities of the source material

260nm: not greater than 0.20

280nm: not greater than 0.15

Molar ratio of sulfate ions to carboxylate ions

Not less than 1.8

Heavy metals

Not more than 20 ppm

Loss on drying

Not more than 10%

Bacterial endotoxins

Less than 0.01 IU/AⅩaIU

 

Changshan Biochemical Pharmaceutical(Jiangsu)Co.,Ltd          Supported by Wuxi KingWay Technology