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CAS NO.:9041-08-1 | Pharmacopoeia standard：EP / USP |
HS CODE :3001.9010.00 | File service ：Chinese GMP/ DMF |
Source：Porcine intestine mucosa.
Characters：White or almost white powder, highly hygroscopic.
Process：Heparin sodium is extracted from healthy porcine intestine mucosa.
Test Items | Company Specification | ||
EP | USP | ||
Characters | White or almost white powder, highly hygroscopic | ||
Identification | Thrombotest: Conforms | Chromatographic identity:Conforms | |
1H NMR Spectrum: Conforms | 1H NMR Spectrum: Conforms | ||
Liquid Chromatography: Conforms | Weight-average molecular weight: 15000~19000 | ||
Sodium:Conforms | Sodium: Conforms | ||
Anti-factor Xa to anti-factorIIa ratio:0.9~1.1 | Anti-factor Xa to anti-factorIIa ratio:0.9~1.1 | ||
Tests | Clarity and color | Clarity: Clear, Color: by 5 or better | ———— |
Nitrogen | 1.5～2.5%（dry substance） | 1.3～2.5%（dry substance） | |
Nucleotidic impurities | A260≤ 0.15(4mg/ml) | ≤ 0.1（w/w） | |
Related substances | Conforms | ———— | |
Limit ofgalactosamine in total hexosamine | ———— | ≤ 1.0% | |
Oversulfated chondroitin sulfate | ———— | Conforms | |
pH | 5.5～8.0（1%） | 5.5～7.5（1%） | |
Loss on drying | ≤ 8.0%（60℃Dry in Vacuum, 3h） | ≤ 5.0%（60℃Dry in Vacuum, 3h） | |
Residue on ignition | ———— | 28.0%～41.0% | |
Bacterial endotoxin | ≤ 0.01 IU/International Unit of Heparin | ≤ 0.03USPU/International Unit of Heparin | |
Heavy metal | ≤ 30ppm | ≤ 30ppm | |
Sodium | 10.5～13.5%（dry substance） | ———— | |
Proteins | ≤ 0.5%（dry substance） | ≤ 0.1%（Weight ratio） | |
Activity | ≥180 IU/mg（dry substance） | ≥180 USP U/mg（dry substance） | |
Microbial Impurities | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | Conforms | Conforms | |
Staphylococcus aureus | Conforms | Conforms | |
Salmonella | Conforms | Conforms | |
CRO
