Ifemu yethu igcizelela ngaso sonke isikhathi inqubomgomo yekhwalithi “yekhwalithi ephezulu yomkhiqizo iyisisekelo sokusinda kwenkampani;ubumnandi bomthengi kungaba indawo yokubuka kanye nesiphetho senhlangano;ukuthuthuka okuqhubekayo kuwukuphishekela abasebenzi kwaphakade” kanye nenjongo engaguquki “yokuba nesithunzi kuqala, umthengi kuqala” Yekhwalithi Ephezulu Yekhemisi Yempahla Yebanga I-CAS 8049-47-6 Pancreatin, Sidlala indima ehamba phambili ekuhlinzekeni amakhasimende ngemikhiqizo yekhwalithi ephezulu isevisi enhle. namanani ancintisanayo.
Ifemu yethu igcizelela ngaso sonke isikhathi inqubomgomo yekhwalithi “yekhwalithi ephezulu yomkhiqizo iyisisekelo sokusinda kwenkampani;ubumnandi bomthengi kungaba indawo yokubuka kanye nesiphetho senhlangano;ukuthuthuka okuqhubekayo kuwukuphishekela abasebenzi kwaphakade” kanye nenjongo engaguquki yokuthi “idumela kuqala, umthengi kuqala”I-China CAS 8049-47-6 kanye ne-Pancreatic, Setha uhlelo oluqinile lokulawula ikhwalithi.Sinenqubomgomo yokubuyisela nokushintshisana, futhi ungashintsha phakathi kwezinsuku ezingu-7 ngemva kokuthola amawigi uma esesiteshini esisha futhi sinikeza isevisi yokulungisa mahhala ukuze uthole izixazululo.Qiniseka ukuthi uzizwa ukhululekile ukusithinta ukuze uthole ulwazi olwengeziwe uma unemibuzo.Siyajabula ukusebenzela wonke amaklayenti.
1. Izinhlamvu: I-Pancreatin iyimpushana ensundu kancane, e-amorphous noma insundu kancane ukuya kugranule enombala kakhilimu.Yakhiwa i-amylase, i-lipase ne-protease.
2. Ukukhipha Umthombo: Amanyikwe engulube.
3. inqubo: I-Pancreatin ikhishwa kuma-pancreas enempilo ngobuchwepheshe bethu obukhethekile bokukhipha.
4 .Izinkomba kanye nokusetshenziswa: I-Pancreatin iyingxube yama-enzyme amaningana okugaya akhiqizwa amanyikwe engulube.Ingasetshenziswa embonini yezemithi, ukucutshungulwa kokudla, ukushuka, ukuwasha neminye imikhakha, enezinhlelo eziningi ezahlukene.
·Kwenziwe ku-workshop ye-GMP
·Iminyaka engama-27 yomlando we-enzyme yebhayoloji ye-R&D
·Izinto ezingavuthiwe ziyalandeleka
·Thobela izinga lamakhasimende
·Thumela emazweni nasezifundeni ezingaphezu kuka-30
·Inekhono lokuphatha uhlelo lwekhwalithi njenge-US FDA, Japan PMDA, South Korea MFDS, njll.
Izinto Zokuhlola | Ukucaciswa Kwenkampani | |||
CP | EP | USP | ||
Izinhlamvu | Impushana | Impushana ensundu kancane, e-amorphous | Impushana ensundu kancane, e-amorphous | Impushana ensundu kancane, e-amorphous |
I-Granule | Igranule enombala onsundu kancane ukuya kokhilimu | Igranule enombala onsundu kancane ukuya kokhilimu | Igranule enombala onsundu kancane ukuya kokhilimu | |
Ukuhlonza | ———— | Kuyavumelana | ———— | |
Izivivinyo | Okuqukethwe kwamafutha | ≤20mg/g | ≤ 5.0% | ≤3.0%(<3USP);≤ 6.0%(≥3USP) |
Ukulahlekelwa ekomisweni | ≤5.0% 105℃, 4h | ≤ 5.0% 670Pa 60℃, 4h | ≤ 5.0%Yomisa ku-Vacuum 60℃, 4h | |
I-solvent eyinsalela | ———— | ≤ 0.5%Ngokuya nge-EP(5.4) | ≤ 0.5%Ngokuya nge-USP(467) | |
Usayizi wezinhlayiya | ———— | Ngokusho kwe-EP(2.1.4&2.9.12) | Ngokusho kwe-USP(811) | |
Isivivinyo | I-Protease | ≥600U/g | 1.0–5.2Ph.Eur.U/mg | 100-450USP.U/mg |
I-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 | |
Ukungcola Kwe-Microbial | I-TAMC | ≤ 10000cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
I-TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | Kuyavumelana | Kuyavumelana | Kuyavumelana | |
I-Salmonella | Kuyavumelana | Kuyavumelana | Kuyavumelana |
Ifemu yethu igcizelela ngaso sonke isikhathi inqubomgomo yekhwalithi “yekhwalithi ephezulu yomkhiqizo iyisisekelo sokusinda kwenkampani;ubumnandi bomthengi kungaba indawo yokubuka kanye nesiphetho senhlangano;ukuthuthuka okuqhubekayo kuwukuphishekela abasebenzi kwaphakade” kanye nenjongo engaguquki “yokuba nesithunzi kuqala, umthengi kuqala” Yekhwalithi Ephezulu Yekhemisi Yempahla Yebanga I-CAS 8049-47-6 Pancreatin, Sidlala indima ehamba phambili ekuhlinzekeni amakhasimende ngemikhiqizo yekhwalithi ephezulu isevisi enhle. namanani ancintisanayo.
Ikhwalithi ephezulu yeI-China CAS 8049-47-6 kanye ne-Pancreatic, Setha uhlelo oluqinile lokulawula ikhwalithi.Sinenqubomgomo yokubuyisela nokushintshisana, futhi ungashintsha phakathi kwezinsuku ezingu-7 ngemva kokuthola amawigi uma esesiteshini esisha futhi sinikeza isevisi yokulungisa mahhala ukuze uthole izixazululo.Qiniseka ukuthi uzizwa ukhululekile ukusithinta ukuze uthole ulwazi olwengeziwe uma unemibuzo.Siyajabula ukusebenzela wonke amaklayenti.