Products
Pancreatin yeDeebio ine Kugadzira Hupfu, Granule uye Pellet
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.
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 | |||
| 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 | |
