-
1
-
-
49449104944
-
-
Impurities in New Drug Substances Q3A(R), International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2002.
-
Impurities in New Drug Substances Q3A(R), International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2002.
-
-
-
-
2
-
-
17044409165
-
Pharmaceutical applications of liquid chromatography coupled with mass spectrometry (LC/MS)
-
Lee, H. Pharmaceutical applications of liquid chromatography coupled with mass spectrometry (LC/MS). J. Liq. Chromatogr. & Rel. Technol. 2005, 28, 1161-1202.
-
(2005)
J. Liq. Chromatogr. & Rel. Technol
, vol.28
, pp. 1161-1202
-
-
Lee, H.1
-
3
-
-
33846214776
-
Isolation and identification of a major impurity in a new bulk drug candidate by preparative LC, ESI-MSn, LC-MS-MS, and NMR
-
Li, N.; Yang, J.; Qin, F.; Li, F.; Gong, P. Isolation and identification of a major impurity in a new bulk drug candidate by preparative LC, ESI-MSn, LC-MS-MS, and NMR. J. Chromatogr. Sci. 2007, 45, 45-49.
-
(2007)
J. Chromatogr. Sci
, vol.45
, pp. 45-49
-
-
Li, N.1
Yang, J.2
Qin, F.3
Li, F.4
Gong, P.5
-
4
-
-
29144437267
-
Identification of a trace colored impurity in drug substance by preparative liquid chromatography and mass spectrometry
-
Wang, P.; Shi, Y.; Helmy, R.; Reamer, R.; Vailaya, A. Identification of a trace colored impurity in drug substance by preparative liquid chromatography and mass spectrometry. Rapid Comm. Mass Spectrom. 2005, 19, 3749-3754.
-
(2005)
Rapid Comm. Mass Spectrom
, vol.19
, pp. 3749-3754
-
-
Wang, P.1
Shi, Y.2
Helmy, R.3
Reamer, R.4
Vailaya, A.5
-
5
-
-
4344659257
-
Pharmaceutical impurity identification: A case study using a multidisciplinary approach
-
Alsante, K.M.; Boutros, P.; Couturier, M.A.; Friedmann, R.C.; Harwood, J.W.; Horank, G.J.; Jensen, A.J.; Liu, Q.; Lohr, L.L.; Morris, R.; Raggon, J.W.; Reid, G.L.; Santafianos, D.P.; Sharp, T.R.; Tucker J.L.; Wilcox, G.E. Pharmaceutical impurity identification: A case study using a multidisciplinary approach. J. Pharm. Sci. 2004, 93(9), 2296-2309.
-
(2004)
J. Pharm. Sci
, vol.93
, Issue.9
, pp. 2296-2309
-
-
Alsante, K.M.1
Boutros, P.2
Couturier, M.A.3
Friedmann, R.C.4
Harwood, J.W.5
Horank, G.J.6
Jensen, A.J.7
Liu, Q.8
Lohr, L.L.9
Morris, R.10
Raggon, J.W.11
Reid, G.L.12
Santafianos, D.P.13
Sharp, T.R.14
Tucker, J.L.15
Wilcox, G.E.16
-
6
-
-
26444572354
-
Liquid chromatography-mass spectrometry using the hydrogen/deuterium exchange reaction as a tool for impurity identification in pharmaceutical process development
-
Novak, T.J.; Helmy, R.; Santos, I. Liquid chromatography-mass spectrometry using the hydrogen/deuterium exchange reaction as a tool for impurity identification in pharmaceutical process development. J. Chromatogr. B 2005, 825, 161-168.
-
(2005)
J. Chromatogr. B
, vol.825
, pp. 161-168
-
-
Novak, T.J.1
Helmy, R.2
Santos, I.3
-
7
-
-
34249936489
-
Impurity profile tracking for active pharmaceutical ingredients: Case reports
-
Zhou, L.; Mao, B.; Reamer, R.; Novak, T.; Ge, Z. Impurity profile tracking for active pharmaceutical ingredients: Case reports. J. Pharm. Biomed. Anal. 2007, 44, 421-429.
-
(2007)
J. Pharm. Biomed. Anal
, vol.44
, pp. 421-429
-
-
Zhou, L.1
Mao, B.2
Reamer, R.3
Novak, T.4
Ge, Z.5
-
8
-
-
34249934193
-
Identification of an unknown trace-level impurity in bulk drug of seroquel by high-performance liquid chromatography combined with mass spectrometry
-
Xu, H.; Wang, D.; Sun, C.; Pan, Y.; Zhou, M. Identification of an unknown trace-level impurity in bulk drug of seroquel by high-performance liquid chromatography combined with mass spectrometry. J. Pharm. Biomed. Anal. 2007, 44, 414-420.
-
(2007)
J. Pharm. Biomed. Anal
, vol.44
, pp. 414-420
-
-
Xu, H.1
Wang, D.2
Sun, C.3
Pan, Y.4
Zhou, M.5
-
9
-
-
33746653845
-
Separation and characterization of clindamycin and related impurities in bulk drug by high-performance liquid chromatography-electrospray tandem mass spectrometry
-
Zhou, H.; Zheng, Z.; Wu, S.; Tai, Y.; Cao, X.; Pan, Y. Separation and characterization of clindamycin and related impurities in bulk drug by high-performance liquid chromatography-electrospray tandem mass spectrometry. J. Pharm. Biomed. Anal. 2006, 41, 1116-1123.
-
(2006)
J. Pharm. Biomed. Anal
, vol.41
, pp. 1116-1123
-
-
Zhou, H.1
Zheng, Z.2
Wu, S.3
Tai, Y.4
Cao, X.5
Pan, Y.6
-
10
-
-
34548148984
-
Characterization of the trace-level impurities in the bulk drug citalopram by high-performance liquid chromatography/tandem multistage mass spectrometry
-
Sun, C.; Xu, H.; Pan, Y.; Shen, Z.; Wang. D. Characterization of the trace-level impurities in the bulk drug citalopram by high-performance liquid chromatography/tandem multistage mass spectrometry. Rapid Comm. Mass Spectrom. 2007, 21, 2889-2894.
-
(2007)
Rapid Comm. Mass Spectrom
, vol.21
, pp. 2889-2894
-
-
Sun, C.1
Xu, H.2
Pan, Y.3
Shen, Z.4
Wang, D.5
-
11
-
-
0036027907
-
The isolation and identification of a toxic impurity in XP315 drug substance
-
Sigvardson, K.W.; Adams, S.P.; Barnes, T.B.; Blom, K.F.; Fortunak, J.M.; Haas, M.J.; Reilly, K.L.; Repta A.J.; Nemeth, G.A. The isolation and identification of a toxic impurity in XP315 drug substance. J. Pharm. Biomed. Anal. 2002, 27, 327-334.
-
(2002)
J. Pharm. Biomed. Anal
, vol.27
, pp. 327-334
-
-
Sigvardson, K.W.1
Adams, S.P.2
Barnes, T.B.3
Blom, K.F.4
Fortunak, J.M.5
Haas, M.J.6
Reilly, K.L.7
Repta, A.J.8
Nemeth, G.A.9
-
12
-
-
0242541169
-
LC determination of impurities in methoxsalen drug substance: Isolation and identification of isopimpinellin as a major impurity by atmospheric pressure chemical ionization LC/MS and NMR
-
Lehr, G.J.; Barry, T.L.; Franolic, J.D.; Petzinger, G.; Scheiner, P. LC determination of impurities in methoxsalen drug substance: isolation and identification of isopimpinellin as a major impurity by atmospheric pressure chemical ionization LC/MS and NMR. J. Pharm. Biomed. Anal. 2003, 33, 627-637.
-
(2003)
J. Pharm. Biomed. Anal
, vol.33
, pp. 627-637
-
-
Lehr, G.J.1
Barry, T.L.2
Franolic, J.D.3
Petzinger, G.4
Scheiner, P.5
-
13
-
-
24044540747
-
Recent studies on the electrospray ionization mass spectrometric behavior of selected nitrogen-containing drug molecules and its application to drug analysis using liquid chromatography-electrospray ionization mass spectrometry
-
Smyth, W.F. Recent studies on the electrospray ionization mass spectrometric behavior of selected nitrogen-containing drug molecules and its application to drug analysis using liquid chromatography-electrospray ionization mass spectrometry. J. Chromatogr. B 2005, 824, 1-20.
-
(2005)
J. Chromatogr. B
, vol.824
, pp. 1-20
-
-
Smyth, W.F.1
-
14
-
-
28644434549
-
Structure elucidation and total synthesis of a unique group of trace impurities in Tipranavir drug product
-
Busacca, C.A.; Campbell, S.; Saha, A.; Lorenz, J.C.; Grozinger, K.; Jones, P.J.; Grinberg, N.; Shen, S.; Lee, H.; Qiu, F.; Granger, A.; Yuabova, Z.; Norwood, D.; Senanayake, C.H. Structure elucidation and total synthesis of a unique group of trace impurities in Tipranavir drug product. Mag. Res. Chem. 2005, 43, 1032-1039.
-
(2005)
Mag. Res. Chem
, vol.43
, pp. 1032-1039
-
-
Busacca, C.A.1
Campbell, S.2
Saha, A.3
Lorenz, J.C.4
Grozinger, K.5
Jones, P.J.6
Grinberg, N.7
Shen, S.8
Lee, H.9
Qiu, F.10
Granger, A.11
Yuabova, Z.12
Norwood, D.13
Senanayake, C.H.14
-
15
-
-
2942521265
-
Improving the detection of degradants and impurities in pharmaceutical drug products by applying mass spectral and chromatographic searching
-
Freed, A.L.; Kale, U.; Ando, H.; Rossi, D.T.; Kingsmill, C.A. Improving the detection of degradants and impurities in pharmaceutical drug products by applying mass spectral and chromatographic searching. J. Pharm. Biomed. Anal. 2004, 35, 727-738.
-
(2004)
J. Pharm. Biomed. Anal
, vol.35
, pp. 727-738
-
-
Freed, A.L.1
Kale, U.2
Ando, H.3
Rossi, D.T.4
Kingsmill, C.A.5
-
18
-
-
0037462519
-
Gas chromatography with mass spectrometric, atomic emission and Fourier transform infrared spectroscopic detection as complementary analytical techniques for the identification of unknown impurities in pharmaceutical analysis
-
Laniewski, K.; Wannman, T.; Hagman, G. Gas chromatography with mass spectrometric, atomic emission and Fourier transform infrared spectroscopic detection as complementary analytical techniques for the identification of unknown impurities in pharmaceutical analysis. J. Chromatogr. A 2003, 985, 275-282.
-
(2003)
J. Chromatogr. A
, vol.985
, pp. 275-282
-
-
Laniewski, K.1
Wannman, T.2
Hagman, G.3
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