Isu tinotevera manejimendi ekutonga ekuti "Hunhu hwepamusoro-mhando, Kambani yakakura, Track rekodhi yekutanga", uye tichagadzira nemoyo wese kubudirira nevatengi vese veYakanyatsogadzirwa Factory Price Pharmaceutical Chemical Pancreatin Purity Degree 99% CAS No. 8049 -47-6, Kugamuchirwa shamwari dzinobva kumativi ese epasi dzinoratidzika kushanya, kutungamira uye kutaurirana.
Isu tinotevera manejimendi ehutongi hwe "Hunhu hwepamusoro-mhando, Kambani yepamusoro, Track rekodhi ndiyo yekutanga", uye tichagadzira nemoyo wese uye nekugovana budiriro nevatengi vese.China Pancreatin uye CAS Nhamba 8049-47-6, Isuwo tine simba rakasimba rekubatanidza kupa basa redu rakanakisisa, uye kuronga kuvaka imba yekuchengetera zvinhu munyika dzakasiyana-siyana pasi rose, izvo zvingangove zviri nyore kushumira vatengi vedu.
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 tinotevera manejimendi ekutonga ekuti "Hunhu hwepamusoro-mhando, Kambani yakakura, Track rekodhi yekutanga", uye tichagadzira nemoyo wese kubudirira nevatengi vese veYakanyatsogadzirwa Factory Price Pharmaceutical Chemical Pancreatin Purity Degree 99% CAS No. 8049 -47-6, Kugamuchirwa shamwari dzinobva kumativi ese epasi dzinoratidzika kushanya, kutungamira uye kutaurirana.
Yakagadzirwa zvakanakaChina Pancreatin uye CAS Nhamba 8049-47-6, Isuwo tine simba rakasimba rekubatanidza kupa basa redu rakanakisisa, uye kuronga kuvaka imba yekuchengetera zvinhu munyika dzakasiyana-siyana pasi rose, izvo zvingangove zviri nyore kushumira vatengi vedu.