01 (?)02 (?)0304 -05
??????? K3 ??? ???? ?????? ???????.
????????
(1) ???? ????????: ?????? ????? (???: ??????, ????, ?? ????? ????); ?????? ????? (???: ????, ??????? ????); ?????? ???? ?? ?????? ???? (???: ?????? ???, ???? ?? ????, ???, ?????? ???? ?????? ?? ???? ????? ????); ?????? ?? ?????? ????? (???: ?? ????, ?????? ????, ?????? ?? ????? ????).
(2) ???????? ????????: ??????? ?? ??? ?????? ?????????; ?????????? ??? ???????? ????????????; ??????? ?????????? ?? ??????? ????????? ????? ?? ??? ??????; ?????? ?? ?????? ?????, ?? ????? ?? ??? ?????? ?????? ?????; ???? ???????? ?????; ???? ?????? ????? ???? ??????? ????????? ????????????? ???? ??????? ?????????? ??? ???? ????. ??? ??????? ???????? ?? ????????? ???????? ?? ?????-?????????? ???????? ??? ????? ???? ?????? ????; ?????????? ???????? ????? ??????.
(3) ??? ????????: ?????????? ?????, ??????? K, ??????? A, ??? ??????? ???? ????????? ???????? ??????? ????????????.
???????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 ppm | |
???????? | 99.0%~101.0%(EP/USP/BP ??????????? ????) | |
??????????? ??????????? ????????? | ||
???? ???? ??? | ≤1000cfu/??????? | |
?????? ?? ????? | ≤100cfu/??????? | |
?. ????. | ????????? | |
???????????? | ????????? | |
???. ?????? | ????????? |