0102030405
??????? 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/g | |
???? ??? ???? | ≤100cfu/g | |
?. ????? | ???????? | |
????????? | ???????? | |
??. ????? | ???????? |