Tuam Tshoj Kallidinogenase ntawm Deebio rau Ntau Yam Kev Mob plawv thiab Cerebovascular Disease Hoobkas thiab manufacturers |Deejiotech

Kallidinogenase ntawm Deebio rau ntau yam kab mob plawv thiab kab mob Cerebovascular Featured duab

Kallidinogenase ntawm Deebio rau ntau yam kab mob plawv thiab Cerebovascular

CAS Nr.:9001-01-8

HS CODE:3507.9090.90 Nws

Kev Pabcuam Cov Ntaub Ntawv:Suav-GMP, DMF

Pharmacopoeia standard:JP/CP

Xa email rau peb qauv dawb

Product Detail

Khoom cim npe

Paub meej

1. Cov Cim: Cov hmoov dawb los yog yuav luag dawb, tsis muaj ntxhiab tsw.

2. Extraction Source: Porcine pancreas.

3. Cov txheej txheem: Kallidinogenase yog muab rho tawm los ntawm kev noj qab haus huv porcine pancreas.

4. Cov lus qhia thiab kev siv: Cov khoom no tuaj yeem siv rau ntau yam kab mob plawv thiab paj hlwb, xws li kab mob hauv lub plawv, mob hlab ntsha hlwb, cerebral thrombosis, retinal blood supply disorders thiab peripheral vascular disease.Muaj kev kho mob zoo dua ntawm kev tshawb fawb tsis ntev los no rau thr tiv thaiv kab mob ntshav qab zib microangiopathy thaum ntxov thiab ntshav qab zib nephropathy, tuaj yeem txo qis albumin excretion.Cov ntaub ntawv kho mob ob qho tib si hauv tsev thiab txawv teb chaws qhia tias nws tuaj yeem ua kom cov phev ua haujlwm thiab ntau lawm, thiab muaj qee yam kev kho mob hauv kev kho mob ntawm qee tus txiv neej sterility.

Vim li cas peb?

· Ua nyob rau hauv GMP Rhiav

· 27 xyoo ntawm biological enzyme R & D keeb kwm

· Cov ntaub ntawv nyoos yog traceable

· Ua raws li 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		CP	JP
Cov cim		Dawb los yog yuav luag dawb hmoov, tsw tsw	Dawb mus rau me ntsis xim av hmoov, tsw tsw los yog muaj ib tug faint
Kev txheeb xyuas		R (hydrolysis tus nqi): 0.12～0.17 ib	R (hydrolysis tus nqi): 0.12～0.16
Kev txheeb xyuas		Liquid Chromatography: Conforms	Kuv : ≤ 0.2
Kev sim	pH	5.5～7.5(300 units / ml)	5.5～7.5(1g / 300ml)
	Clarity ntawm kev daws	Ntshiab(2 mg/ml)	——————
	Rog	≤ 5.0mg / g	≤ 1.0mg / g
	Kininase	——————	R Tus nqi:≥ 0.8
	Cov khoom zoo li trypsin	——————	T Tus nqi:≤ 0.05
	Protease	A₂₈₀≤ 0.2	A₂₈₀≤ 0.2
	Poob rau ziab	≤ 5.0% (60 ℃ Qhuav hauv Nqus tsev, 4h)	≤ 2.0% (60 ℃ Qhuav hauv Nqus tsev, 4h)
	Residue ntawm ignition	≤ 3.0%	≤ 3.0%
	Kinin-tso kev ua si	——————	≥ 500ng bradykinin sib npaug/min/unit ib unit
	Purity	≥75% (rau qhov ncauj)	——————
	Purity	≥ 90% (rau kev txhaj tshuaj)	——————
	Cov kab mob endotoxin	≤ 2.5 EU / unit (rau kev txhaj tshuaj)	——————
Assay	Kev ua haujlwm enzyme	——————	≥ 25 units / mg
	Cov haujlwm tshwj xeeb	≥ 300 units / mg protein (rau qhov ncauj)	≥ 100 units / mg protein
	Cov haujlwm tshwj xeeb	≥ 600 units / mg protein (rau txhaj tshuaj)	≥ 100 units / mg protein
Microbial impurities	TAMC	≤ 1000cfu / g (rau qhov ncauj)	≤ 1000cfu / g
	TAMC	≤ 100cfu / g (rau txhaj tshuaj)	≤ 1000cfu / g
	TYMC	≤ 100cfu / g	≤ 100cfu / g
	E.coli	Ua raws	Ua raws
	Salmonella	Ua raws	Ua raws