China Kupisa Zvigadzirwa Zvitsva Pancreatin (CAS No. 8049-47-6) GMP Factory Cetificied fekitori uye vanogadzira |Deebiotech

Zvinopisa Zvigadzirwa Zvitsva Pancreatin (CAS No. 8049-47-6) GMP Factory Cetificied

Nhamba yeCAS:8049-47-6

HS CODE:3507.9090.90

Faira Service:Chinese-GMP/EU-GMP/DMF/EU-DMF

Pharmacopoeia standard:EP/USP/CP

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Isu tinogara tichiwana basa kuti tive vashandi vanobatika kuti tive nechokwadi chekuti tinogona kukupa iwe zvakanakisa zvemhando yepamusoro uye kukosha kukuru kweHot New Products Pancreatin (CAS No. 8049-47-6) GMP Factory Cetificied, Chete kuti uite. chigadzirwa chemhando yakanaka kana sevhisi kugutsa zvinodiwa nemutengi, zvese zvigadzirwa zvedu zvakanyatsoongororwa zvisati zvatumirwa.
Isu tinogara tichiita kuti basa riitwe kuti tive vashandi vanobatika kuti tive nechokwadi chekuti tinogona kukupa zviri nyore zvemhando yepamusoro uye kukosha kukuruChina Pancreatin uye 8049-47-6, Nekuenderera mberi nekuvandudza, tichakupa iwe nezvimwe zvakakosha zvinhu uye masevhisi, uye zvakare kuita mupiro wekusimudzira indasitiri yemotokari kumba nekune dzimwe nyika.Vese vatengesi vekumba nevekunze vanogamuchirwa zvakasimba kuti vabatane nesu kuti tikure pamwe chete.

Detail

1. Hunhu: Pancreatin ipfumbu yakati rebei, amorphous poda kana kuti shava zvishoma kune granule ine ruvara rwekrimu.Iyo inoumbwa neamylase, lipase uye protease.

2. Kubvisa Kunobva: Porcine pancreas.

3. maitiro: Pancreatin inotorwa kubva kune ine hutano porcine pancreas neyedu chete activation-extraction tekinoroji.

4 .Zviratidzo uye kushandiswa: Pancreatin musanganiswa wema enzymes akawanda ekugaya anogadzirwa nepancreas yenguruve.Inogona kushandiswa muindasitiri yemishonga, kugadzira chikafu, kusukwa, kuwacha nemimwe minda, ine huwandu hwakawanda hwekushandisa.

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Sei isu?

· Yakagadzirwa muGMP musangano

· Makore makumi maviri nemanomwe ebhayoloji enzyme R&D nhoroondo

·Maraw materials anotarisika

·Kutevedzera mwero wevatengi

·Tumira kunze kwenyika dzinopfuura makumi matatu nematunhu

·Ane kugona kwemhando yekutonga system seUS FDA, Japan PMDA, South Korea MFDS, nezvimwe.

Tsanangudzo

Test Items		Kutsanangurwa kwekambani
Test Items		CP	EP	USP
Vanhu	Upfu	Hupfu hwakasvibira zvishoma, amorphous	Hupfu hwakasvibira zvishoma, amorphous	Hupfu hwakasvibira zvishoma, amorphous
Vanhu	Granule	Granule ine ruvara rutsvuku zvishoma kune runyoro	Granule ine ruvara rutsvuku zvishoma kune runyoro	Granule ine ruvara rutsvuku zvishoma kune runyoro
Identification		————	Conforms	————
Miedzo	Mafuta emukati	≤20mg/g	≤ 5.0%	≤3.0%(<3USP);≤ 6.0%(≥3USP)
	Kurasikirwa pakuomeswa	≤5.0% 105℃, 4h	≤ 5.0% 670Pa 60℃, 4h	≤ 5.0%Dry in Vacuum 60℃, 4h
	Residual solvent	————	≤ 0.5%Maererano neEP(5.4)	≤ 0.5%Maererano neUSP(467)
	Chikamu saizi	————	Zvinoenderana neEP(2.1.4&2.9.12)	Maererano neUSP(811)
Assay	Protease	≥600U/g	1.0–5.2Ph.Eur.U/mg	100～450USP.U/mg
	Amylase	≥7000U/g	12.0～80.0Ph.Eur.U/mg	100～500USP.U/mg
	Lipase	≥4000U/g	15.0～130Ph.Eur.U/mg	10～90USP.U/mg
Kusvibiswa kweMicrobial	TAMC	≤ 10000cfu/g	≤ 10000cfu/g	≤ 10000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Conforms	Conforms	Conforms
	Salmonella	Conforms	Conforms	Conforms

Isu tinogara tichiwana basa kuti tive vashandi vanobatika kuti tive nechokwadi chekuti tinogona kukupa iwe zvakanakisa zvemhando yepamusoro uye kukosha kukuru kweHot New Products Pancreatin (CAS No. 8049-47-6) GMP Factory Cetificied, Chete kuti uite. chigadzirwa chemhando yakanaka kana sevhisi kugutsa zvinodiwa nemutengi, zvese zvigadzirwa zvedu zvakanyatsoongororwa zvisati zvatumirwa.
Hot New ProductsChina Pancreatin uye 8049-47-6, Nekuenderera mberi nekuvandudza, tichakupa iwe nezvimwe zvakakosha zvinhu uye masevhisi, uye zvakare kuita mupiro wekusimudzira indasitiri yemotokari kumba nekune dzimwe nyika.Vese vatengesi vekumba nevekunze vanogamuchirwa zvakasimba kuti vabatane nesu kuti tikure pamwe chete.

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