Heparin Sodium de Deebio tractans Morbum thromboembolicum praeventionis

Heparin Sodium of Deebio for Treating Thromboembolic Disease Prevention Featured Image

Heparin Sodium de Deebio tractans Morbum thromboembolicum praeventionis

CAS NO.:9041-08-1

HS CODEX:3001.9010.00

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Product Detail

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Detail

1. Characteres: albi vel fere albi pulveris, valde hygroscopici.

2. Source: Porcinum intestinum mucosa.

3. Process: Heparin sodium extrahitur ex mucosa porcino intestino sano.

4. Indicationes et usus: Hoc productum maxime adhibetur ad morbos thromboembolicos praeventionis, praesertim ad necessitatem cito anticoagulantis, ut: 1. Acutus vel chronicus thrombosis venosus vel sanguinis fluxus dynamicae mutationis embolismi pulmonis non significantis (PE). embolus extensio sistere potest ad tempus vacandum pro thrombolysi corporis spontanea.2. Praeventionis et curatio fibrillationis atrialis cum embolismo.3. Curatio coagulationis intravascularis mane diffusa (DIC).4. Praeventionis et curatio thrombosis arteriarum peripheralium vel myocardialium infarctionis.5. Alia in vitro anticoagulation: sicut chirurgica cardiovascularis, in vitro circulation, hemodialysis, angiographia, adhiberi potest etiam ad praeparationem speciminis transfusionis vel sanguinis, nunc praecipua indicia applicationis heparin sunt venae altae thrombosis (DVT), PE et thrombosis. in magno periculo aegris.

quare nos?

· Transierunt Sinica GMP

· XXVII annos biologicos enzyme R&D history

· Rudis materia deprauationis

· parere cum USP.EPac elit vexillum

· Export ut supra XXX regiones et regiones

· Potestas administrationis systematis qualitatis habet ut US FDA, Iaponia PMDA, Corea Meridiana MFDS, etc.

Specification

Test Items		Societas Specification
Test Items		EP	USP
Characteres		Alba vel fere cerussa, altus hygroscopic
Lepidium sativum		Thrombotest: Conforms	Identitatem chromatographicam: Conforms
		¹H NMR Spectrum: Conforms	¹H NMR Spectrum: Conforms
		Liquid Chromatography: Conforms	Pondus mediocris hypothetica pondus: (XV) ~ (XIX)
		Sodium: Conforms	Sodium: Conforms
		Anti-factor Xa ad rationem anti-factorem IIa: 0.9~ 1.1	Anti-factor Xa ad rationem anti-factorem IIa: 0.9~ 1.1
Tests	Claritas et color	Claritas: Serena, Color: per 5 vel melius	----
	Nitrogen	1.52.5%.arida substantia.	1.32.5%.arida substantia.
	immunditias nucleotidicas	A₂₆₀≤ 0.15(4mg/ml)	≤ 0.1.w/w*.
	Substantiae cognatae	Conforms	----
	Terminus ofgalactosamine in summa hexosamine	----	≤ 1.0%
	Oversulfated chondroitin sulfate	----	Conforms
	pH	5.58.0.1%.	5.57.5.1%.
	Damnum in siccitate	≤ 8.0%.60℃ sicca in Vacuo, 3h.	≤ 5.0%.60℃ sicca in Vacuo, 3h.
	Reliqua ignitio	----	28.0%41.0%
	Bacteria endotoxin	≤ 0.01 IU/International Unitas Heparin	≤ 0.03 USP U / Unitas Internationalis Heparin
	Grave metallum	≤ 30ppm	≤ 30ppm
	Natrium	10.513.5%.arida substantia.	----
	Dapibus	≤ 0.5%.arida substantia.	≤ 0.1%.Ratio pondus.
Actio		≥ 180 IU/mg.arida substantia.	≥ 180 USP U/mg.arida substantia.
Microbial immunditias	TAMC'	≤ 1000cfu/g	≤ 1000cfu/g
	TYMC	≤ 100cfu/g*	≤ 100cfu/g*
	E.coli	Conforms	Conforms
	Staphylococcus aureus	Conforms	Conforms
	Salmonella	Conforms	Conforms