01 ?????? ????? 01020304 ?????04 ??????05
??????? K3 ?? ????????? ???????
??????????
(1) ???? ??????: ?????? ?????? (???. ?????????, ????, ?????? ??????? ????????); ??????? ???? ?????? (???. ??????, ??????? ????????); ?????????? ????? ?????????? (???. ????? ???, ???? ????? ?????, ??????, ?????????? ????? ??????? ????????? ??????? ????????); ??????? ????? ?????? ?????? (???. ?? ??????, ??????, ?????? ????? ???????? ????????).
(2) ????????? ??????: ?????????? ????? ??????? ????? ?????????; ????????? ?????? ???????? ????????????; ????? ??????? ????? ????????? ??????????? ?????? ????? ?????????; ?????? ????? ??????? ??????, ?????? ????? ??? ?????? ????? ??????; ?????? ???? ?????? ??????; ?????? ?????? ?????? ?????????? ??????? ????????????? ?????????? ????????? ?? ????????????. ???? ?????? ???????? ????????????? ????? ??????? ?????? ????? ??????????? ????????? ????? ????????? ????????????; ?????????? ?????? ????????.
(3) ??????????????? ??????: ?????????? ?????, ??????? ??, ??????? ?, ??????????????? ?????????????? ?????? ???? ?????????? ????? ??????????.
?????2
??????
1. ??????? K3 ????? ?????????????? ???????????????? ????? ??????? K3 ??????????????? ??????????? ?????????.
2. ??????? K3 ????? ?????????? ????????????. ??????? K3 ?? ???????? ???????? ?? ???????? ???? ????? ??????? ???????? ????????????? ????? ??????? ????????.
3. ??????? K3 ?????? ??????????????? ??????????, ??? ???? ????????????????? ????????????????, ????? ??????? ?????????? ??????????????? ????? ??????? ???????????? ????? ?????? ????????? ???????????????.
4. ??????? K3 ????????? ????????????? ???? ????????????????, ????????? ????????, ?????????, ???????? ???????????, ???? ?????? ?????? ?????? ??????? ?????????.



???????? ?????
???? | ?????????? | |
???????????? ???? ???????? | 1. H-NMR: ???????? ????? ???? ???? ????????? ??????? ???????. | |
2. HPLC-MS: ?????? ????? ????? ???? ????? ????? ?????? ????? ???? ????????? ??????? ???????? ????????????????. | ||
3. IR: IR ????? ???? ????????? ????????????? ??????? ???????. | ||
??????? (HPLC) | ≥99.0% | |
??????? ??????? | ????????? ?? ?????? | EP/USP/BP ?????????? ????????? ??????? |
?????????? ???? ?? ?????? | ≤0.10% | |
?????? ??????? | ≤0.50% | |
?????? ???? | EP/USP/BP ?????????? ????????? ??????? | |
?????????? ???? ????? ????? | ≤1.0% | |
???? | ≤1.0% | |
?????? ????? | ≤0.1% | |
???? ?????? | ≤10 ?????? | |
?????? | 99.0%~101.0%(EP/USP/BP ???????? ???????) | |
?????????? ???????? | ||
?????? ?????? ????????? | ≤1000cfu/???? | |
????? ????? ??????? | ≤100cfu/???? | |
E. ????. | ????????? | |
???????????? | ????????? | |
???. ?????? | ????????? |