抗生素的质量 分析与研究
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antibiotic19441950s1980s
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1990smicrobial medicine
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50352011.4.7WHO20012011FDA3/12 30GSKAstraZeneca
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NMRBBP/ChP93.0%USP85.0%A3+B+A1A1HPLCUVIRNMRMS
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TLCHPLC
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A-78C-65-62ChP-78-71D()L()48
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ChP6.0%3.0% 3.0%
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-490nmA
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5150m
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ICHChP
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-2-2-GC13-2-0.3%0.8%33%
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----2mg/day4g-100 ppmChPHPLC
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USP1990 GGG
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50m
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96HPLC5
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HPLC-UVHPLC-ELSDChP HPLC--UVHPLC-ECDBPUSPGCBP BP USP
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Sephadex G10--
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Superdex Piptide VTSK 2000SWXL ChP:
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TSK2500 PWXL TSK Gel G2500 HXL- cefcapene prvoxil hydrochloride
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/
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water activity
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N- BPUSPJPIC ChPtITP-CZEIC ICNMPNMP+
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N-ICNMP + NMP10%
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N-tITP-CZEtITPNMP + pH4.74~7CZE0.003%0.01%
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MEKCHPLC(ChP)AHPLCTLCHPLCCEHPLCHPLCHPLCHILICTLCGCCE(EP/BP)
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MEKC
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Offline-2D-HPLC-CE
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RP-IP-HPLC-PED
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RP-IP-HPLC-ELSD
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Analysis of underivatized gentamicin by CE-UV detection
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precapillary-derivatization-MEKC
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EMMA-CZEprecapillary-derivatization-CZE
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EMMA-CZEprecapillary-derivatization-CZE
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CZE-C4D
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1969
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HPLC
0
2
4
6
8
10
12
14
16
Time [min]
0.0
0.5
1.0
1.5
2.0
2.5
6
x10
Intens.
EIC 137 -All MS
EIC 155 -All MS
EIC 200 -All MS
EIC 258 -All MS
EIC 275 -All MS
EIC 396 -All MS
b
d
a
fosfomycin
c
e
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tITP-CZE-UV
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CZE-UV
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/
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QbD
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ICH
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2009
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J2011, 46: 928/(QSPR/QSAR)201125710
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NMR(2011374241272012.12)USP/BPpH3.55.5ChPpH4.07.0
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X-NMR-2009
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