Tuam Tshoj Heparin Sodium ntawm Deebio rau Kev Kho Mob Thromboembolic Tiv Thaiv Hoobkas thiab manufacturers |Deejiotech

Heparin Sodium ntawm Deebio rau Kev Kho Mob Thromboembolic Tiv Thaiv

CAS Nr.:9 041-08-1

HS CODE:3001.9010.00 Nws

Kev Pabcuam Cov Ntaub Ntawv:Suav-GMP, DMF

Pharmacopoeia standard:EP/USP

Xa email rau peb qauv dawb

Product Detail

Khoom cim npe

Paub meej

1. Cim: Dawb los yog yuav luag dawb hmoov, hygroscopic heev.

2. Source: Porcine plab hnyuv mucosa.

3. Cov txheej txheem: Heparin sodium yog muab rho tawm los ntawm kev noj qab haus huv porcine plab hnyuv mucosa.

4. Cov lus qhia thiab kev siv: Cov khoom no tsuas yog siv rau kev tiv thaiv kab mob thromboembolic, tshwj xeeb tshaj yog tsim nyog rau kev xav tau ntawm anticoagulant sai, xws li: 1. mob venous thrombosis los yog tsis muaj ntshav txaus dynamic hloov pulmonary embolism (PE).Heparin tuaj yeem nres embolus txuas ntxiv los ua lub sijhawm rau thrombolysis ntawm lub cev.2. Kev tiv thaiv thiab kev kho mob ntawm Atrial fibrillation nrog embolism.3. Kev kho mob thaum ntxov diffuse intravascular coagulation (DIC).4. Kev tiv thaiv thiab kev kho mob ntawm peripheral arterial thrombosis lossis myocardial infarction.5. Lwm yam hauv vitro anticoagulation: xws li kev phais plawv, hauv vitro ncig, hemodialysis, angiography, kuj tuaj yeem siv rau kev tso ntshav lossis ntshav npaj, tam sim no cov lus qhia tseem ceeb ntawm daim ntawv thov heparin yog cov hlab ntsha sib sib zog nqus (DVT), PE thiab thrombosis. nyob rau hauv cov neeg mob uas muaj kev pheej hmoo siab.

Vim li cas peb?

· Dhau Suav GMP

· 27 xyoo ntawm biological enzyme R & D keeb kwm

· Cov ntaub ntawv nyoos yog traceable

· Ua raws li USP,EPthiab cov neeg siv khoom tus qauv

· Export rau ntau tshaj 30 lub teb chaws thiab cheeb tsam

· Muaj peev xwm ntawm kev tswj xyuas zoo xws li US FDA, Nyiv PMDA, Kaus Lim Qab Teb MFDS, thiab lwm yam.

Specification

Cov khoom kuaj		Tuam txhab Specification
Cov khoom kuaj		EP	USP
Cov cim		Dawb los yog yuav luag dawb hmoov, hygroscopic heev
Kev txheeb xyuas		Thrombotest: Ua raws	Chromatographic tus kheej: Conforms
		¹H NMR Spectrum: Ua raws	¹H NMR Spectrum: Ua raws
		Liquid Chromatography: Conforms	Qhov hnyav-qhov nruab nrab molecular hnyav: 15000 ~ 19000
		Sodium: Conforms	Sodium: Conforms
		Anti-factor Xa rau anti-factor IIa piv: 0.9 ~ 1.1	Anti-factor Xa rau anti-factor IIa piv: 0.9 ~ 1.1
Kev sim	Clarity thiab xim	Clarity: Ntshiab, Xim: los ntawm 5 lossis zoo dua	——————
	Nitrogen	1.5～2.5%(cov khoom qhuav)	1.3～2.5%(cov khoom qhuav)
	Nucleotidic impurities	A₂₆₀≤ 0.15 (4mg / ml)	≤ 0.1(w/w)
	Cov khoom muaj feem xyuam	Ua raws	——————
	Kev txwv ntawm galactosamine hauv tag nrho hexosamine	——————	≤ 1.0%
	Oversulfated chondroitin sulfate	——————	Ua raws
	pH	5.5～8.0 ib(1%)	5.5～7.5(1%)
	Poob rau ziab	≤ 8.0%(60 ℃ Qhuav hauv Nqus tsev, 3h)	≤ 5.0%(60 ℃ Qhuav hauv Nqus tsev, 3h)
	Residue ntawm ignition	——————	28.0%～41.0%
	Cov kab mob endotoxin	≤ 0.01 IU/International Unit of Heparin	≤ 0.03 USP U/International Unit of Heparin
	Hnyav hlau	≤ 30ppm	≤ 30ppm
	Sodium	10.5～13.5%(cov khoom qhuav)	——————
	Cov protein	≤ 0.5%(cov khoom qhuav)	≤ 0.1%(Qhov hnyav piv)
Kev ua si		≥ 180 IU/mg(cov khoom qhuav)	≥ 180 USP U / mg(cov khoom qhuav)
Microbial impurities	TAMC	≤ 1000cfu / g	≤ 1000cfu / g
	TYMC	≤ 100cfu / g	≤ 100cfu / g
	E.coli	Ua raws	Ua raws
	Staphylococcus aureus	Ua raws	Ua raws
	Salmonella	Ua raws	Ua raws