Tine matekinoroji epamberi uye zvivakwa, mubato wakasimba wemhando yepamusoro, mwero unonzwisisika, masevhisi epamusoro uye kubatana kwepedyo netarisiro, isu takazvipira kupa mutengo wakanakisa kune vatengi vedu veFekitori Inopa China Medical Graderaw Material Pancreatin Powder yeDigestion neBRC. Chitupa, Gamuchirai chero yekubvunza uye kunetsekana nezvezvinhu zvedu, isu tinotarisa kumberi kwekugadzira bhizinesi renguva refu bhizinesi muchato pamwe newe munguva pfupi yapfuura.tidane nhasi.
Tine matekinoroji epamberi uye zvivakwa, mubato wakasimba wemhando yepamusoro, mwero unonzwisisika, masevhisi epamusoro uye kubatana kwepedyo netarisiro, takazvipira kupa mutengo wakanyanya kune vatengi vedu.China Pancreatic Enzyme Pancreatin Powder, Digestive Pancreatic Enzyme Powder, Kudzora kwakasimba kwehutano kunoitwa mune imwe neimwe yekubatanidza yezvese kugadzirwa process.Tine tarisiro yechokwadi yekumisikidza hushamwari uye kuwirirana-kunobatsira kubatana newe.Kubva pane zvemhando yepamusoro zvekutengesa uye yakakwana pre-kutengesa / mushure-yekutengesa sevhisi ipfungwa yedu, vamwe vatengi vanga vashanda nesu kweanopfuura makore mashanu.
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.
· 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.
Test Items | Kutsanangurwa kwekambani | |||
CP | EP | USP | ||
Vanhu | Upfu | Hupfu hwakasvibira zvishoma, amorphous | Hupfu hwakasvibira zvishoma, amorphous | Hupfu hwakasvibira zvishoma, amorphous |
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 |
Tine matekinoroji epamberi uye zvivakwa, mubato wakasimba wemhando yepamusoro, mwero unonzwisisika, masevhisi epamusoro uye kubatana kwepedyo netarisiro, isu takazvipira kupa mutengo wakanakisa kune vatengi vedu veFekitori Inopa China Medical Graderaw Material Pancreatin Powder yeDigestion neBRC. Chitupa, Gamuchirai chero yekubvunza uye kunetsekana nezvezvinhu zvedu, isu tinotarisa kumberi kwekugadzira bhizinesi renguva refu bhizinesi muchato pamwe newe munguva pfupi yapfuura.tidane nhasi.
Factory Yakananga kupaChina Pancreatic Enzyme Pancreatin Powder, Digestive Pancreatic Enzyme Powder, Kudzora kwakasimba kwehutano kunoitwa mune imwe neimwe yekubatanidza yezvese kugadzirwa process.Tine tarisiro yechokwadi yekumisikidza hushamwari uye kuwirirana-kunobatsira kubatana newe.Kubva pane zvemhando yepamusoro zvekutengesa uye yakakwana pre-kutengesa / mushure-yekutengesa sevhisi ipfungwa yedu, vamwe vatengi vanga vashanda nesu kweanopfuura makore mashanu.