Isu tanga takazvipira kupa hukasha hunokosha, zvinhu zvakasarudzika zvemhando yepamusoro, sezvakangoita kukurumidza kuendesa Yemhando yepamusoro Pancreatin 8049-47-6 ine Inonzwisisika Mutengo GMP Setifiketi Chigadzirwa, Hukasha kutengesa mutengo nemhando yepamusoro uye masevhisi anogutsa anoita kuti tiwane. vateki vakawanda.tinoda kushanda newe uye kutsvaga kuvandudzwa kwakafanana.
Isu tanga takazvipira kupa hukasha kukosha, yakasarudzika zvinhu zvakanaka mhando, zvakafanana nekukasira kuendesa kune.China Pancreatin uye 8049-47-6, Isu tanga tichigara tichiwedzera musika mukati meRomania pamwe nekugadzirira kubaya mune zvekuwedzera zvemhando yepamusoro zvekutengesa zvakabatana neprinta pat shirt kuitira kuti iwe ugone Romania.Vanhu vazhinji vanotenda zvakasimba kuti tine simba rose rekukupa mhinduro dzinofadza.
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 tanga takazvipira kupa hukasha hunokosha, zvinhu zvakasarudzika zvemhando yepamusoro, sezvakangoita kukurumidza kuendesa Yemhando yepamusoro Pancreatin 8049-47-6 ine Inonzwisisika Mutengo GMP Setifiketi Chigadzirwa, Hukasha kutengesa mutengo nemhando yepamusoro uye masevhisi anogutsa anoita kuti tiwane. vateki vakawanda.tinoda kushanda newe uye kutsvaga kuvandudzwa kwakafanana.
High Quality forChina Pancreatin uye 8049-47-6, Isu tanga tichigara tichiwedzera musika mukati meRomania pamwe nekugadzirira kubaya mune zvekuwedzera zvemhando yepamusoro zvekutengesa zvakabatana neprinta pat shirt kuitira kuti iwe ugone Romania.Vanhu vazhinji vanotenda zvakasimba kuti tine simba rose rekukupa mhinduro dzinofadza.