1. Inyuguti: Ifu yera cyangwa hafi yera, hygroscopique.
2. Gukuramo Inkomoko: Utubuto twa pisine karitsiye nk'amagufwa yo mu muhogo, amagufwa yizuru, trachea.
3. inzira: Chondroitin Sulfate Sodium ikurwa mubice bya karcine nziza.
4. Ibyerekana kandi bikoreshwa: Iki gicuruzwa kirashobora gukoreshwa mububabare bwa neuropathique, kubabara umutwe wa migraine, kubabara hamwe, kuvura kanseri yo mu maraso menshi, birashobora kandi gukoreshwa mukurinda no kuvura indwara zifata imitsi ya aterosklerotike, amaraso na cholesterol izamuka, angina, neuralgia, myocardial ischemia, atherosclerose, ariko kandi irashobora gukoreshwa nk'inyongeramusaruro mubiribwa n'ibiryo byubuzima.
· Yatsinze Abashinwa GMP
· Imyaka 27 ya enzyme ya biologiya R&D amateka
· Ibikoresho bibisi birashobora gukurikiranwa
· Gukurikiza CP 、 EP 、 USP hamwe nabakiriya
· Kohereza mu bihugu birenga 30
· Ifite ubushobozi bwo gucunga neza sisitemu nka US FDA, Ubuyapani PMDA, Koreya yepfo MFDS, nibindi.
Ibizamini | Ibisobanuro bya sosiyete | |||
CP | EP | USP | ||
Inyuguti | Ifu yera cyangwa hafi yera, hygroscopique | Ifu yera cyangwa hafi yera, hygroscopique | ||
Kumenyekanisha | Igishushanyo cya IR: Ihuza | Igishushanyo cya IR: Ihuza | Igishushanyo cya IR: Ihuza | |
Sodium: Ihuza | Sodium: Ihuza | Sodium: Ihuza | ||
———— | Electrophoresis: Ihindura | Ibigize disaccharide: Guhuza | ||
Ibizamini | Ibisobanuro | ———— | ———— | Biragaragara: A.420≤ 0.35 (5%) |
Kuzunguruka byihariye | -25 ° ~ -32 ° | -20。~ -30。(5%) | -20。~ -30。(30mg / ml) | |
Kwinjira imbere | ———— | 0.01~0.15m3 / kg | ———— | |
Ibintu bifitanye isano | ———— | Guhindura | Guhindura | |
pH | 6.0~7.0 | 5.5~7.5(5%) | 5.5~7.5(1%) | |
Gutakaza kumisha | ≤ 10.0%(105 ℃ 4h) | ≤ 12.0%(105 ℃ 4h) | ≤ 12.0%(105 ℃ 4h) | |
Ibisigara byo gutwikwa | 20.0%~30.0%(ibintu byumye) | ———— | 20.0%~30.0%(ibintu byumye) | |
Chloride | ≤ 0.5% | ≤ 0.5% | ≤ 0.5% | |
Sulfate | ≤ 0.24% | ———— | ≤ 0.24% | |
Icyuma kiremereye | ≤ 20ppm | ≤ 20ppm | ≤ 20ppm | |
Amashanyarazi meza | ———— |
| Guhindura | |
Poroteyine | ———— | ≤ 3.0%(ibintu byumye) | ≤ 6.0%(ibintu byumye) | |
Igisigara gisigaye | Guhindura | Guhindura | Guhindura | |
Disaccharides idafite akamaro | ———— |
| ≤ 10.0% | |
Ibirimo | 90.0~105.0%(ibintu byumye) | 95.0~105.0% (ibintu byumye) | 90.0~105.0%(ibintu byumye) | |
Microbial Impurities | TAMC | C 1000cfu / g | C 1000cfu / g | C 1000cfu / g |
TYMC | C 100cfu / g | C 100cfu / g | C 100cfu / g | |
E.coli | Guhindura | Guhindura | Guhindura | |
Salmonella | Guhindura | Guhindura | Guhindura | |
Staphylococcus aureus | ———— | Guhindura | ———— | |
Pseudomonas aeruginosa | ———— | Guhindura | ———— | |
Bile-Tolerant Gram-Bagiteri mbi | ———— | C 100cfu / g | ———— |