1. Abalinganiswa:Umdaka okhanyayo, umgubo wehygroscopic, ivumba elibonakalayo kunye nencasa.
2. Umthombo: Isibindi senkomo.
3. Inkqubo:Isicatshulwa sesibindi senkomo sitsalwa kwisibindi senkomo esisempilweni.
4. Izibonakaliso kunye nokusetyenziswa: Isicatshulwa sesibindi sisetyenziselwa ukuphucula ukusebenza kwesibindi, ukunyanga izifo zesibindi ezingapheliyo, ukukhusela umonakalo ophilayo, kunye nokuvuselela izicubu zesibindi.Ikwasetyenziselwa i-anemia ebangelwa ukunqongophala kwe-Vitamin B.
·Iveliswe kwiworkshop yeGMP
· Iminyaka engama-27 yembali ye-enzyme yebhayoloji ye-R&D
·Imathiriyeli ekrwada iyalandeleka
·Thobela umgangatho wabathengi kunye neshishini
·Thumela ngaphandle kumazwe angaphezu kwama-30 kunye nemimandla
·Unamandla olawulo lwenkqubo esemgangathweni efana ne-US FDA, Japan PMDA, South Korea MFDS, njl.
Izinto zovavanyo | IshishiniSumgangatho | |
Abalinganiswa | Ukukhanya okumdaka, umgubo wehygroscopic, ivumba elibonakalayo kunye nencasa. | |
Ukuchongwa | Ichromatography eThin-layer: iyahambelana | |
Uvavanyo | Ilahleko ekomisweni | ≤ 5.0% |
Ukunyibilika | Cacileyo | |
pH | 5.0 - 6.0(I-5% isisombululo samanzi) | |
Intsalela ekutshisweni | ≤ 3.0% | |
Sulfate | ≤ 5% | |
Iyonke initrogen | 11.8% - 14.4% | |
Amino nitrogen | 6.0% - 7.5% | |
VB12 Umxholo | ≥ 10 μg/g | |
Uvavanyo lweMicrobial | TAMC | ≤ 1000cfu/g |
I-TYMC | ≤ 100cfu/g | |
E.coli | Ukungabikho /g | |
Salmonella | Ukungabikho / 10g | |
Iintsholongwane ezikwaziyo ukumelana negram-egative | ≤100cfu/g | |
Staphylococcus aureus | Ukungabikho /g | |
Pseudomonas aeruginosa | Ukungabikho /g |