Awọn ọja
Pancreatin ti Deebio pẹlu Ilana ti Lulú, Granule ati Pellet
Ẹ̀kúnrẹ́rẹ́
1. Awọn ohun kikọ: Pancreatin jẹ awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ, amorphous lulú.O jẹ ti amylase, lipase ati protease.
2. Orisun isediwon: Porcine pancreas.
3. ilana: Pancreatin ti wa ni jade lati inu ti oronro porcine ti ilera nipasẹ imọ-ẹrọ isediwon-iyasọtọ wa.
4 .Awọn itọkasi ati lilo: Pancreatin jẹ idapọ ti awọn enzymu ti ounjẹ ti ounjẹ ti a ṣe nipasẹ ti oronro ti porcine.O le ṣee lo ni ile-iṣẹ oogun, ṣiṣe ounjẹ, soradi, fifọ ati awọn aaye miiran, pẹlu ọpọlọpọ awọn ohun elo.
Kini idi ti wa?
· Ti ṣejade ni idanileko GMP
· ọdun 27 ti itan-akọọlẹ R&D henensiamu ti ibi
· Awọn ohun elo aise jẹ itọpa
· Ni ibamu pẹlu boṣewa onibara
Ṣe okeere si awọn orilẹ-ede ati agbegbe ti o ju 30 lọ
· Ni agbara ti iṣakoso eto didara gẹgẹbi US FDA, Japan PMDA, South Korea MFDS, ati bẹbẹ lọ.
Sipesifikesonu
| Awọn nkan Idanwo | Ile-iṣẹ pato | |||
| CP | EP | USP | ||
| Awọn ohun kikọ | Lulú | Awọ brown diẹ, lulú amorphous | Awọ brown diẹ, lulú amorphous | Awọ brown diẹ, lulú amorphous |
| Granule | Awọ-awọ-awọ-awọ-awọ-awọ-awọ-granule die-die | Awọ-awọ-awọ-awọ-awọ-awọ-awọ-granule die-die | Awọ-awọ-awọ-awọ-awọ-awọ-awọ-granule die-die | |
| Idanimọ | ———— | Ni ibamu | ———— | |
| Idanwo | Ọra akoonu | ≤20mg/g | ≤ 5.0% | ≤3.0%(<3USP);≤ 6.0%(≥3USP) |
| Pipadanu lori gbigbe | ≤5.0% 105℃, 4h | ≤ 5.0% 670Pa 60℃, 4h | ≤ 5.0% Gbẹ ninu Vacuum 60℃, 4h | |
| Aloku to ku | ———— | ≤ 0.5% Ni ibamu si EP (5.4) | ≤ 0.5% Ni ibamu si USP(467) | |
| Iwọn patiku | ———— | Gẹgẹbi EP (2.1.4 & 2.9.12) | Gẹgẹbi USP (811) | |
| Ayẹwo | Proteate | ≥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 | |
| Makirobia impurities | TAMC | ≤ 10000cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
| TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
| E.coli | Ni ibamu | Ni ibamu | Ni ibamu | |
| Salmonella | Ni ibamu | Ni ibamu | Ni ibamu | |
