China Ukulethwa okusheshayo China Amakhemikhali Heparin Sodium ifektri nabakhiqizi |I-Deebiotech

Ukulethwa okusheshayo China Amakhemikhali Heparin Sodium

INOMBOLO YECAS.9041-08-1

IKHODI YE-HS:3001.9010.00

Isevisi Yefayela:I-Chinese-GMP, i-DMF

I-Pharmacopoeia ejwayelekile:EP/USP

Thumela i-imeyili kithi isampula yamahhala

Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Inkampani yethu ibigxile kakhulu esu lomkhiqizo.Ukwaneliseka kwamakhasimende ukukhangisa kwethu okuhle kakhulu.Siphinde sinikeze umhlinzeki we-OEM wokulethwa okusheshayo kwe-China ChemicalsI-Heparin Sodium, Ukuthuthukiswa okungapheli nokulwela ukuntula okungu-0% kuyizinqubomgomo zethu ezimbili eziyinhloko zekhwalithi.Uma kukhona okudingayo, ungangabazi ukuxhumana nathi.
Inkampani yethu ibigxile kakhulu esu lomkhiqizo.Ukwaneliseka kwamakhasimende ukukhangisa kwethu okuhle kakhulu.Siphinde sinikeze umhlinzeki we-OEM weI-Heparin Sodium, Sikholelwa kukhwalithi nokwaneliseka kwamakhasimende okuzuzwa ithimba labantu abazinikele kakhulu.Ithimba lenkampani yethu elisebenzisa ubuchwepheshe besimanje liletha izimpahla ezisezingeni eliphezulu ezikhonzwe kakhulu futhi zaziswa amakhasimende ethu emhlabeni wonke.

Imininingwane

1. Izinhlamvu: Impushana emhlophe noma ecishe ibe mhlophe, ene-hygroscopic kakhulu.

2. Umthombo: I-porcine intestine mucosa.

3. Inqubo: I-Heparin sodium ikhishwa ku-mucosa yamathumbu e-porcine enempilo.

4. Izinkomba kanye nokusetshenziswa: Lo mkhiqizo usetshenziselwa ikakhulukazi ukuvimbela isifo se-thromboembolic, ikakhulukazi esilungele isidingo se-anticoagulant ngokushesha, njengalokhu: 1. I-acute noma engapheli ye-venous thrombosis noma akukho ukugeleza kwegazi okuphawulekayo ushintsho olunamandla lwe-pulmonary embolism(PE).Heparin ingamisa ukunwetshwa kwe-embolus ukwenza isikhathi se-thrombolysis ezenzakalelayo yomzimba.2. Ukuvimbela nokwelashwa kwe-Atrial fibrillation nge-embolism.3. Ukwelashwa kwe-diffuse intravascular coagulation (DIC) yokuqala.4. Ukuvimbela nokwelashwa kwe-peripheral arterial thrombosis noma i-myocardial infarction.5. Enye i-in vitro anticoagulation: njengokuhlinzwa kwenhliziyo nemithambo yegazi, i-in vitro circulation, i-hemodialysis, i-angiography, nayo ingasetshenziselwa ukumpontshelwa noma ukulungiselela isifanekiso segazi, okwamanje izinkomba eziyinhloko zokusetshenziswa kwe-heparin i-deep vein thrombosis(DVT), i-PE kanye ne-thrombosis. ezigulini ezisengozini enkulu.

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Kungani sisi?

·Uphumelele i-Chinese GMP

·Iminyaka engama-27 yomlando we-enzyme yebhayoloji ye-R&D

·Izinto ezingavuthiwe ziyalandeleka

·Thobela i-USP、EP kanye nezinga lekhasimende

·Thumela emazweni nasezifundeni ezingaphezu kuka-30

·Inekhono lokuphatha uhlelo lwekhwalithi njenge-US FDA, Japan PMDA, South Korea MFDS, njll.

Ukucaciswa

Izinto Zokuhlola		Ukucaciswa Kwenkampani
Izinto Zokuhlola		EP	USP
Izinhlamvu		Impushana emhlophe noma ecishe ibe mhlophe, ene-hygroscopic kakhulu
Ukuhlonza		I-Thrombotest: Iyavumelana	Ubunikazi beChromatographic: Kuyavumelana
		¹I-H NMR Spectrum: Iyavumelana	¹I-H NMR Spectrum: Iyavumelana
		I-Liquid Chromatography: Iyavumelana	Isisindo-isilinganiso samangqamuzana isisindo: 15000 ~ 19000
		I-Sodium: Iyavumelana	I-Sodium: Iyavumelana
		I-Anti-factor Xa ukuya ku-anti-factor IIa isilinganiso:0.9~1.1	I-Anti-factor Xa ukuya ku-anti-factor IIa isilinganiso:0.9~1.1
Izivivinyo	Ukucaca nombala	Ukucaca: Kucacile, Umbala: ngo-5 noma ngaphezulu	————
	I-nitrogen	1.5-2.5% (into eyomile)	1.3-2.5% (into eyomile)
	Ukungcola kwe-Nucleotidic	A₂₆₀≤ 0.15(4mg/ml)	≤ 0.1 (w/w)
	Izinto ezihlobene	Kuyavumelana	————
	Umkhawulo wegalactosamine ku-hexosamine isiyonke	————	≤ 1.0%
	I-Oversulfate chondroitin sulfate	————	Kuyavumelana
	pH	5.5-8.0 (1%)	5.5-7.5 (1%)
	Ukulahlekelwa ekomisweni	≤ 8.0% (60℃ Yomisa ku-Vacuum, 3h)	≤ 5.0% (60℃ Yomisa ku-Vacuum, 3h)
	Izinsalela ekushiseni	————	28.0%～41.0%
	I-endotoxin yebhaktheriya	≤ 0.01 IU/Iyunithi Yamazwe Ngamazwe Ye-Heparin	≤ 0.03 USP U/Iyunithi Yamazwe Ngamazwe Ye-Heparin
	Insimbi enzima	≤ 30ppm	≤ 30ppm
	Isodium	10.5-13.5% (into eyomile)	————
	Amaprotheni	≤ 0.5% (into eyomile)	≤ 0.1% (isilinganiso sesisindo)
Umsebenzi		≥ 180 IU/mg (into eyomile)	≥ 180 USP U/mg (into eyomile)
Ukungcola Kwe-Microbial	I-TAMC	≤ 1000cfu/g	≤ 1000cfu/g
	I-TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Kuyavumelana	Kuyavumelana
	I-Staphylococcus aureus	Kuyavumelana	Kuyavumelana
	I-Salmonella	Kuyavumelana	Kuyavumelana

Inkampani yethu ibigxile kakhulu esu lomkhiqizo.Ukwaneliseka kwamakhasimende ukukhangisa kwethu okuhle kakhulu.Siphinde sinikeze umhlinzeki we-OEM wokulethwa Okusheshayo I-China Chemicals Heparin Sodium, ukuthuthukiswa okungapheli kanye nokulwela ukuntula okungu-0% yizinqubomgomo zethu ezimbili eziyinhloko zekhwalithi.Uma kukhona okudingayo, ungangabazi ukuxhumana nathi.
Ukulethwa okusheshayo kwe-China Anticoagulant, Pharmaceutical Intermediates, Sikholelwa kwikhwalithi nokwaneliseka kwamakhasimende okuzuzwa iqembu labantu abazinikele kakhulu.Ithimba lenkampani yethu elisebenzisa ubuchwepheshe besimanje liletha izimpahla ezisezingeni eliphezulu ezikhonzwe kakhulu futhi zaziswa amakhasimende ethu emhlabeni wonke.

Okwedlule: Ukulethwa okusheshayo China Amakhemikhali Heparin Sodium

Olandelayo: Incazelo ephezulu yase-China Ifekthri Yamanani Angcono Kakhulu I-Heparin Sodium CAS 9041-08-1 Imithombo Yezinkomo Nezingulube

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