Heparin Sodium
Synonyms: Ardeparin sodium; Dalteparin Sodium; Tinzaparin Sodium; Fragmin; Sodium Heparin
Molecular Formula: (C12H16NS2Na3)20
Molecular Weight: 12000
CAS Registry Number: 9041-08-1; 101921-26-0; 102785-31-9; 12656-11-0
Water solubility: Soluble in water
Standard: CP/EP/USP/BP/EP6/Crude
Content(POTENCY): 180U/mg
Heparin Sodium injection
Specification: 5000IU/2ML, 2500IU/5ML
Heparin, a natural anticoagulant, is a kind of sulphated glycosaminoglycans. The moldcule is a chain structure consisting orepeated hexose or octose units, its main disaccharide units is trithionicacid disaccharide. Heparin persents in warious mammalian tissues including liver, lung, heart, spleen, kidney, thymus, intestinal mucosa, muscle and blood. Thus heparin can be extracted from healthy porcine intestinal mucosa and lung or healthy bovine lung, all stages of production and procurement must be conducted under the supervision of Quality Management System. The production technology is validated by the virus inactivated production process, so the harmful contaminants can be removed.
It is composed of polymers of altemating derivatives of α -D-glucosamine(N-sulfated, O-sulfated, orN-acetylated) and uronicacid(α -L-induronic acid or β -D-glucuronic acid) joined by glycosidic linkages. Some of these components have the property of prolonging the clotting time of blood.
Heparin in animal tissues bound with proteins resulted in glucoprotein complex which is a in vivo present form. So the peparation process inculding two steps: Glucoprotein extracting and dissociation, heaprin isolation and purfifcation. There are sulfonic acid and carboxyl group in heparin and show highly acidic, chemical reaction between this polyanion with cation resulted in salt. The cation includs metallic cation such as Ca2+/Na+/K+, organic base pyridinium compound such as hexadecylpyridinium cholride (CPC), brucine/basicdye-azure A, cationic surface active agent (hexadecyl trimethylammonium bromide)such as catin exchanger and electropositive protein such as protamine ect. N-sulfonic acid in heparin structure is closely related with its anticoagulant activily, thus the activity will decreased after this chemical structuer was destroyed. The strucure is sensitive to acid hydrolysis and stable under basic condition. The dissociated hydroxyl of heparin is easy to be esterized, sulfonation will lead to activity decreasing while acetyization has no such effects.
Heparin sodium is a white or off-white color powder, odorless, hygroscopir, freely soluble in water and insoluble in orgenic solvent such as ethanol, acetone, dioxane and so on. Optical rodation and characteristic absorption peak at 185-220mm, infrared characteristic absorption peak ta 890cm-1, 940cm-1, absorption value at 1210-1150cm-1 was used to determine rapidly.
Efficacy: These components have the property of prolonging the clotting time of blood. This occurs mainly through the formation of a complex of each component with the plasma proteins antithrombin and heparin cofactor II to potentiate the inactivation of thrombin (factor IIa).
Heparin sodium crude
Heparinoid
Heparin sodium injectable
Heparin sodium topical
Heparin calcium
Low molecular mass heparin
Enoxaparin sodium
Parnaparin sodium
Tinzaparin sodium
Daltparin sodium
Nadroparin sodium
Heparan sulfate
Dermatan sulfate
Low Molecular Weight Heparin Sodium Injection PSF & ampules
Enoxaparin sodium injection PSF & ampules
| Producition Name |
Heparin Sodium |
Bacth No : |
140602 |
| Net Weight : |
1.000kg |
Total Quantity : |
194.00MEGAS |
| Date of Produce : |
24-Jun-2014 |
Date of Test: |
28- Jun -2014 |
| TEST ITEMS |
SPECIFICATIONS |
TEST RESULTS |
| Characters |
WHITE 0R WHITE LIKE POEDER |
Complies |
| Solubility |
Freely soluble in water |
Complies |
| Identificatin |
A; Delay of cloting of recalcified cimated sheep plasma.
B;1H-NMR Spectrum; Comply with the EP speacification of heparin about 1H-NMR requiremenls.
C; The principal peak in the chromatogram obtained with test solution is similar in retention time and shape to the principal peak in the chromatogram obtained with reference solution.
D; Positive sodium reaction. |
Complies
Complies
Complies
Complies |
| pH |
5.5~8.0 |
6.6 |
| Realated substances |
A:Sum of dermantan sulfate and chondroitin sulfate:≤2.0%
B:Any other impurity Free |
Complies
Complies |
| Appearance of solution |
A:5%w/v solution is clear and colourlesss
B:Solution is not more inicnscly coloured than reference solution BY5 or better |
Complies
Complies |
| Heavy metals |
≤30ppm |
Complies |
| Loss on drying |
≤8.0% |
1.4% |
| Protein |
≤0.5% |
0.07% |
| Nitrogen |
1.5%~2.5% |
2.2% |
| Sodium |
9.5%~12.5% |
12.1% |
| Sulphated ash |
28%~41.0% |
37.3% |
| Nueleotide impurlties |
260nm≤0.15 |
260n 0.07 |
| Microbial contamination |
A: Total viable acrobic count: max.10 CFU/g
B;Fung yeasts: max. 10 CFU/g
C; Specified micro orgnisms
Escherichina coli
Salmonclla
Pscudomonas aeruginosa |
10 CFU/g
10 CFU/g
Negative
Negative
Negative |
| Residual solvents |
Ethanol: Not more than 5000 ppm |
955ppm |
| Bacterial endotoxins |
0.01IU/IU of heparin |
Complies |
| Impurlfy (NMR) |
The N-acetyl protons of heparin show a single peak at
2.04±0.02ppm No peak should be visible at 2.16±0.03ppm |
Complies |
| POTENCY |
≥180 u/mg |
194 u/mg |
CONCLUSl0N |
CONFORH T0 THE REQUIREMENT OF EP7.0 STANDARD |
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