1. Izinhlamvu:Insundu ngokukhanyayo, impushana eyi-hygroscopic, iphunga elibonakalayo kanye nokunambitha.
2. Umthombo Wokukhipha:Isibindi senkomo.
3. Inqubo: Ukukhishwa kwesibindi senkomo kukhishwa esibindini sezinkomo esinempilo.
4. Izinkomba kanye nokusetshenziswa: Ukukhishwa kwesibindi kusetshenziselwa ukuthuthukisa ukusebenza kwesibindi, ukwelapha izifo zesibindi ezingapheli, ukuvimbela ukulimala okuphilayo, nokuvuselela izicubu zesibindi.Isetshenziselwa futhi i-anemia ebangelwa ukuntula kwe-Vitamin B.
Ikhiqizwe ku-workshop ye-GMP
·Iminyaka engama-27 yomlando we-enzyme yebhayoloji ye-R&D
·Izinto ezingavuthiwe ziyalandeleka
·Thobela ikhasimende kanye nezinga lebhizinisi
·Thumela emazweni nasezifundeni ezingaphezu kuka-30
·Inekhono lokuphatha uhlelo lwekhwalithi njenge-US FDA, Japan PMDA, South Korea MFDS, njll.
Izinto Zokuhlola | IbhizinisiSejwayelekile | |
Izinhlamvu | Insundu ngokukhanyayo, impushana eyi-hygroscopic, iphunga eliyisici kanye nokunambitha. | |
Ukuhlonza | I-chromatography yongqimba oluncane: iyahambisana | |
Isivivinyo | Ukulahlekelwa ekomisweni | ≤ 5.0% |
Ukuncibilika | Kucace | |
pH | 5.0 - 6.0(Isixazululo esinamanzi esingu-5%.) | |
Izinsalela ekushiseni | ≤ 3.0% | |
I-sulfate | ≤ 5% | |
Ingqikithi ye-nitrogen | 11.8% - 14.4% | |
I-amino nitrogen | 6.0% - 7.5% | |
VB12 Okuqukethwe | ≥ 10 μg/g | |
Ukuhlolwa kwe-Microbial | I-TAMC | ≤ 1000cfu/g |
I-TYMC | ≤ 100cfu/g | |
E.coli | Ukungabikho /g | |
I-Salmonella | Ukungabikho / 10g | |
Igciwane elikwazi ukumelana ne-bile gram-egative | ≤100cfu/g | |
I-Staphylococcus aureus | Ukungabikho /g | |
I-Pseudomonas aeruginosa | Ukungabikho /g |