-
1
-
-
33645866459
-
The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development
-
Dobo KL, Greene N, Cyr MO, Caron S, Ku WW. The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development. Reg Toxicol Pharm. 2006;44:282-93.
-
(2006)
Reg Toxicol Pharm
, vol.44
, pp. 282-293
-
-
Dobo, K.L.1
Greene, N.2
Cyr, M.O.3
Caron, S.4
Ku, W.W.5
-
4
-
-
80055027433
-
Committee for Medicinal Products for Human Use [CHMP]
-
Guidelines on the Limits of Genotoxic Impurities. London, Jun 28:28. (CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006)
-
Guidelines on the Limits of Genotoxic Impurities. Committee for Medicinal Products for Human Use [CHMP]. European Medicines Agency [EMEA]. London, 2006 Jun 28:28. (CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006).
-
(2006)
European Medicines Agency [EMEA]
-
-
-
5
-
-
80055036886
-
-
Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches; US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER): Silver Spring, MD, USA, Dec
-
Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches; US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER): Silver Spring, MD, USA, 2008 Dec
-
(2008)
-
-
-
6
-
-
10744227159
-
The Threshold of Toxicological Concern Concept in Risk Assessment
-
Kroes R, Renwick AG, Cheeseman M, Kleiner J, Mangelsdorf I, Piersma A, et al. The Threshold of Toxicological Concern Concept in Risk Assessment. Food Chem Toxicol. 2004;42:65-83.
-
(2004)
Food Chem Toxicol
, vol.42
, pp. 65-83
-
-
Kroes, R.1
Renwick, A.G.2
Cheeseman, M.3
Kleiner, J.4
Mangelsdorf, I.5
Piersma, A.6
-
8
-
-
9344245045
-
Relative molar response of a flame ionization detector to some organic compounds containing sulfur
-
Filby WG, Gunther K, Penzhorn RD. Relative molar response of a flame ionization detector to some organic compounds containing sulfur. Anal Chem. 1975;47:2283-5.
-
(1975)
Anal Chem
, vol.47
, pp. 2283-2285
-
-
Filby, W.G.1
Gunther, K.2
Penzhorn, R.D.3
-
9
-
-
3843114399
-
Trace analysis of residual methyl methanesulfonate, ethyl methanesulfonate and isopropyl methanesulfonate in pharmaceuticals by capillary gas chromatography with flame ionization detection
-
Li W. Trace analysis of residual methyl methanesulfonate, ethyl methanesulfonate and isopropyl methanesulfonate in pharmaceuticals by capillary gas chromatography with flame ionization detection. J Chromator A. 2004;1046:297-301.
-
(2004)
J Chromator A
, vol.1046
, pp. 297-301
-
-
Li, W.1
-
10
-
-
23944465208
-
Determination of methyl and ethyl esters of methanesulfonic, benzenesulfonic and p-toluenesulfonic acids in active pharmaceutical ingredients by solid-phase microextraction (SPME) coupled to GC/SIM-MS
-
Colon I, Richoll SM. Determination of methyl and ethyl esters of methanesulfonic, benzenesulfonic and p-toluenesulfonic acids in active pharmaceutical ingredients by solid-phase microextraction (SPME) coupled to GC/SIM-MS. J Pharm Biomed Anal. 2005;39:477-85.
-
(2005)
J Pharm Biomed Anal
, vol.39
, pp. 477-485
-
-
Colon, I.1
Richoll, S.M.2
-
11
-
-
0042346202
-
Determination of polar alkylating agents as thiocyanate/isothiocyanate derivatives by reaction headspace gas chromatography
-
Lee CR, Guivarch F, Van Dau CN, Ressier D, Krstulovic AM. Determination of polar alkylating agents as thiocyanate/isothiocyanate derivatives by reaction headspace gas chromatography. Analyst, 2003;128:857-63.
-
(2003)
Analyst
, vol.128
, pp. 857-863
-
-
Lee, C.R.1
Guivarch, F.2
Van Dau, C.N.3
Ressier, D.4
Krstulovic, A.M.5
-
12
-
-
35349026723
-
A generic approach for the determination of residues of alkylating agents in active pharmaceutical ingredients by in situ derivatisation-headspace-gas chromatography-mass spectrometry
-
Alzaga R, Ryan RW, Taylor-Worth K, Lipczynski AM, Szucs R, Sandra P. A generic approach for the determination of residues of alkylating agents in active pharmaceutical ingredients by in situ derivatisation-headspace-gas chromatography-mass spectrometry. J Pharm Biomed Anal. 2007;45:472-9.
-
(2007)
J Pharm Biomed Anal
, vol.45
, pp. 472-479
-
-
Alzaga, R.1
Ryan, R.W.2
Taylor-Worth, K.3
Lipczynski, A.M.4
Szucs, R.5
Sandra, P.6
|