1. Characteres: Pancreatinus est subrubra, amorphosus pulvis vel paulo brunneus ad granulum crepis-coloratum.Componitur ex amylase, lipase et protease.
2. Extraction Source: Pancreas Porcine.
3. processum: Pancreatinum e pancreate porcino sano extractum per technologiam nostram exclusivam activationis-extractionis.
4 .Indicationes et usus: Pancreatin est mixtura plurium enzymorum digestivorum a pancreate porcino productorum.Adhiberi potest in pharmaceutica industria, processus cibi, tanning, lavacro et aliis campis, amplis applicationibus.
· Produci in officina GMP
· XXVII annos biologicos enzyme R&D history
· Rudis materia deprauationis
· parere mos vexillum
· Export ut supra XXX regiones et regiones
· Facultatem administrationis qualitatis habet ut FDA, Iaponia PMDA, Corea Meridiana MFDS, etc.
Test Items | Societas Specification | |||
CP | EP | USP | ||
Characteres | Pulvis | A leviter brunneis, amorpho pulveris | A leviter brunneis, amorpho pulveris | A leviter brunneis, amorpho pulveris |
Granule | A leviter brunneis usque ad granulum GILVUS | A leviter brunneis usque ad granulum GILVUS | A leviter brunneis usque ad granulum GILVUS | |
Lepidium sativum | ---- | Conforms | ---- | |
Tests | Adipem content | ≤20mg/g* | ≤ 5.0% | ≤3.0%(<3USP).≤ 6.0%(≥3USP) |
Damnum in siccitate | ≤5.0% 105℃, 4h | ≤ 5.0% 670Pa 60℃, 4h | ≤ 5.0% Siccare in Vacuo 60℃, 4h | |
RELICTUM solvendo | ---- | ≤ 0.5% Secundum EP (5.4) | ≤ 0.5% Secundum USP (467) | |
Magnitudo particula | ---- | Secundum EP(2.1.4&2.9.12) | Secundum USP (DCCCXI) | |
Assay | Protease | ≥600U/g | 1.0~5.2Ph.Eur.U/mg | 100~450USP.U/mg |
Lumbricus | ≥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 | |
Microbial immunditias | TAMC | ≤ 10000cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
TYMC | ≤ 100cfu/g* | ≤ 100cfu/g* | ≤ 100cfu/g* | |
E.coli | Conforms | Conforms | Conforms | |
Salmonella | Conforms | Conforms | Conforms |