01 (?)02 (?)0304 -05
????? ??????? ???????????? ?? ????????
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1. ??? ????????? ??? ??? ????? ??? ??????????? ???? ?????? ?? ???? ???, ??????, ???????? ?????? ?? ??? ?????? ??? ???? ????????? ????? ???? ??????? ??????????????? ?? ???? ??? ??????? ?? ?????.
2. ???????? ??? ??????-??? ??? ????? ??? ???????????, ??????, ???????? ??????, ??? ?????? ?? ??????? ??? ???? ????????? ????? ???? ??? ??????? ?? ???, ??????????? ??? ???????????? (S-FC), ??????????????????????, ????????? (IDUR), ???????????? (BUDR), ??????????? (FUDR) ????????? ? ??. ?? ??????? ??? ??????? ??????????? ??.
3. ???????????? ?????????????????????? ?? ????????? ???? ?????? ???? ??? ????????? ???? ?????? ??.
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?????? | ???????? | ???????? |
?????? | ???? ?? ???? ???? ????; ???? ????, ?? ????. | ???? ????; ???? ????, ?? ????. |
??????????? | ≥95.0% | 99.3% |
????? | 7.0~8.5 | 7.4 ???????? |
???????? ?? ?? ????? | ????? ?? ???????? ??? ????? | ?????? ?? |
?? ????????? (KF) | ≤26.0% | 12.7% |
??? ??? | ≤0.001% | ?????? ?? |
???? ??? | ≤0.00015% | ?????? ?? |
??????????? (HPLC) | ≥98.0% | 99.8% |
????????(UV) | ≥97.0% | 98.9% |