Saina Heparin Sodium o Deebio mo Togafitiga Thromboembolic Faʻamaʻi Puipuiga falegaosimea ma gaosi |Deebiotech

Heparin Sodium o Deebio mo le togafitia o le thromboembolic fa'ama'i Puipuia Ata Fa'aalia

Heparin Sodium o Deebio mo le togafitia o le puipuiga o le thromboembolic

NO. CAS:9041-08-1

HS CODE:3001.9010.00

Auaunaga faila:Saina-GMP, DMF

Pharmacopoeia tulaga:EP/USP

Auina imeli ia matou fa'ata'ita'iga fua

Fa'amatalaga Oloa

Faailoga o oloa

Fa'amatalaga

1. Uiga: Pa'epa'e pe toetoe a pa'epa'e pa'epa'e, maualuga hygroscopic.

2. Punavai: Porcine intestina mucosa.

3. Fa'agasologa: O le sodium Heparin e maua mai le mucosa o le intestinal maloloina.

4. Faʻailoga ma faʻaoga: O lenei oloa e masani ona faʻaaogaina mo le puipuia o faʻamaʻi thromboembolic, aemaise lava mo le manaʻomia o le anticoagulant vave, e pei o: 1. Acute or chronic venous thrombosis poʻo le leai o se suiga tele o le tafe toto o le pulmonary embolism (PE). Heparin e mafai ona taofi le fa'aopoopoga o le embolus e fa'aalu se taimi mo le thrombolysis fa'afuase'i o le tino.2. Puipuia ma le togafitia ole Atrial fibrillation ma le embolism.3. Togafitiga o le vave fa'asalalauina o le intravascular coagulation(DIC).4. Puipuia ma le togafitia o le thrombosis alatoto peripheral po o le myocardial infarction.5. O isi in vitro anticoagulation: e pei o taotoga cardiovascular, in vitro circulation, hemodialysis, angiography, e mafai foi ona faʻaaogaina mo le tuiina poʻo le sauniuniga o suʻega toto, i le taimi nei o faʻamatalaga autu o le faʻaogaina o le heparin o le loloto vein thrombosis (DVT), PE ma le thrombosis. i tagata gasegase maualuga.

Aisea tatou?

· Pasia le GMP Saina

· 27 tausaga o biological enzyme R&D talafaasolopito

· E mafai ona su'eina mea mata'utia

· Mulimuli i le USP、EPma tulaga fa'atau

· Auina atu i fafo i le silia ma le 30 atunuu ma itulagi

· O loʻo i ai le gafatia o pulega lelei faʻapitoa e pei ole US FDA, Iapani PMDA, Korea i Saute MFDS, ma isi.

Fa'amatalaga

Mea Su'ega		Kamupani Fa'amatalaga
Mea Su'ega		EP	USP
Uiga		Pa'epa'e pe toetoe a pa'epa'e pa'epa'e, maualuga hygroscopic
Fa'ailoaga		Thrombotest: Fa'afetaui	Fa'asinomaga Chromatographic: Fa'afetaui
		¹H NMR Alaleo: Fa'afetaui	¹H NMR Alaleo: Fa'afetaui
		Suavai Chromatography: Fa'afetaui	Mamafa-aveve mamafa molecular: 15000~19000
		Sodium: E fetaui	Sodium: E fetaui
		Anti-factor Xa i le anti-factor IIa fua faatatau:0.9~1.1	Anti-factor Xa i le anti-factor IIa fua faatatau:0.9~1.1
Su'ega	Malamalama ma lanu	Malamalama: manino, Lanu: e 5 pe sili atu	————
	Nitrogen	1.5～2.5%(mea mamago）	1.3～2.5%(mea mamago）
	Nucleotidic le mama	A₂₆₀≤ 0.15(4mg/ml)	≤ 0.1(w/w）
	Mea fa'atatau	Fa'atatau	————
	Fa'atapula'a le galactosamine i le aofa'i o le hexosamine	————	≤ 1.0%
	Ova chondroitin sulfate	————	Fa'atatau
	pH	5.5～8.0(1%）	5.5～7.5(1%）
	Ma'imau ile fa'amago	≤ 8.0%(60 ℃ Fa'agogo ile Vacuum, 3h）	≤ 5.0%(60 ℃ Fa'agogo ile Vacuum, 3h）
	Toega ile mu	————	28.0%～41.0%
	Endotoxin siama	≤ 0.01 IU/Iunite Fa'avaomalo o Heparin	≤ 0.03 USP U/Iunite Faava-o-malo o Heparin
	Uamea mamafa	≤ 30ppm	≤ 30ppm
	Sodium	10.5～13.5%(mea mamago）	————
	Polotini	≤ 0.5%(mea mamago）	≤ 0.1%(Fuafuaga o le mamafa）
Gaoioiga		≥ 180 IU/mg(mea mamago）	≥ 180 USP U/mg(mea mamago）
Microbial le mama	TAMC	≤ 1000cfu/g	≤ 1000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Fa'atatau	Fa'atatau
	Staphylococcus aureus	Fa'atatau	Fa'atatau
	Salmonella	Fa'atatau	Fa'atatau