Chatinotarisa pamusoro pacho chinofanira kunge chiri chekubatanidza uye kusimudzira kunaka uye kugadziriswa kwezvigadzirwa zviripo, panguva ino gara uchigadzira zvigadzirwa zvitsva kusangana nevatengi vakasiyana zvinodiwa kuFactory Inopa China Purity Raw Material Pancreatin/Pancreatic Enzyme/Active Pharma Ingredients, Yedu Lab ikozvino "National Lab yedhiziri injini turbo tekinoroji", uye isu tine vashandi vanokwanisa veR&D uye nzvimbo yekuyedza yakakwana.
Chatinotarisa pazviri chinofanira kunge chiri chekubatanidza uye kuwedzera kunaka uye kugadziriswa kwezvigadzirwa zviripo, panguva ino gara uchigadzira zvigadzirwa zvitsva kusangana nevatengi vakasiyana zvinodiwaChina Pancreatin, Pancreatic Enzyme, Zvinhu zvedu zvese zvinotumirwa kune vatengi kuUK, Germany, France, Spain, USA, Canada, Iran, Iraq, Middle East ne Africa.Zvigadzirwa zvedu nemhinduro zvinogamuchirwa zvakanaka nevatengi vedu nekuda kwemhando yepamusoro, mitengo yemakwikwi uye zvitaera zvakanakisa.Isu tinotarisira kumisikidza hukama hwebhizinesi nevatengi vese uye kuunza mamwe mavara akanaka ehupenyu.
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 |
Isu tinopa zvakanangaChina Pancreatin, Pancreatic Enzyme, Zvinhu zvedu zvese zvinotumirwa kune vatengi kuUK, Germany, France, Spain, USA, Canada, Iran, Iraq, Middle East ne Africa.Zvigadzirwa zvedu nemhinduro zvinogamuchirwa zvakanaka nevatengi vedu nekuda kwemhando yepamusoro, mitengo yemakwikwi uye zvitaera zvakanakisa.Isu tinotarisira kumisikidza hukama hwebhizinesi nevatengi vese uye kuunza mamwe mavara akanaka ehupenyu.