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1
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85036906930
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International Conference on Harmonization (ICH) Q3A(R2): Impurities in New Drug Substances (Revised Guideline). First Recommended for Adoption at Step 4 of the ICH Process on 30 March 1995, the guideline was revised under Step 2 of the ICH Process on 7 October 1999 and Recommended for Adoption under Step 4 on 7 February 2002 by the ICH Steering Committee. The Attachment 2 of this guideline has been revised under Step4 without further public consultation on 25 October 2006 (http://www.ich.org/LOB/media/MEDIA422. pdf).
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International Conference on Harmonization (ICH) Q3A(R2): "Impurities in New Drug Substances (Revised Guideline)." First Recommended for Adoption at Step 4 of the ICH Process on 30 March 1995, the guideline was revised under Step 2 of the ICH Process on 7 October 1999 and Recommended for Adoption under Step 4 on 7 February 2002 by the ICH Steering Committee. The Attachment 2 of this guideline has been revised under Step4 without further public consultation on 25 October 2006 (http://www.ich.org/LOB/media/MEDIA422. pdf).
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2
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85036910521
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International Conference on Harmonization (ICH) Q3B(R2): Impurities in New Drug Products (Revised Guideline).This guideline has been revised and finalised under Step 4 in February 2003. The Attachment 2 of this guideline has been revised under Step 4 without further public consultation on 2 June 2006 (http://www.ich.org/LOB/media/MEDIA421.pdf ).
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International Conference on Harmonization (ICH) Q3B(R2): "Impurities in New Drug Products (Revised Guideline)."This guideline has been revised and finalised under Step 4 in February 2003. The Attachment 2 of this guideline has been revised under Step 4 without further public consultation on 2 June 2006 (http://www.ich.org/LOB/media/MEDIA421.pdf ).
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3
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85036918694
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International Conference on Harmonization (ICH) Q3C(R3): Impurities Guideline for Residual Solvents. The tripartite harmonised ICH guideline was finalised (Step 4) in July 1997. This recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutical limits for residual solvents (organic volatile impurities) in drug products (http://www.ich.org/LOB/media/MEDIA423.pdf).
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International Conference on Harmonization (ICH) Q3C(R3): "Impurities Guideline for Residual Solvents." The tripartite harmonised ICH guideline was finalised (Step 4) in July 1997. This recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutical limits for residual solvents (organic volatile impurities) in drug products (http://www.ich.org/LOB/media/MEDIA423.pdf).
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4
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85036929338
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Impurities: Guideline for Residual Solvents (Maintenance). A Maintenance process has been done to revise PDEs, as new toxicological data for solvents becomes available. The two documents have reached Step 4 of the process in September 2002. Both revisions (PDE for THF and PDE for NMP) have been incorporated into the core Guideline in November 2005.
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"Impurities: Guideline for Residual Solvents (Maintenance)." A Maintenance process has been done to revise PDEs, as new toxicological data for solvents becomes available. The two documents have reached Step 4 of the process in September 2002. Both revisions (PDE for THF and PDE for NMP) have been incorporated into the core Guideline in November 2005.
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5
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85036926934
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2006 Edition of the Drinking Water Standards and Health Advisories (EPA 822-R-06-013), Office of Water U.S. Environmental Protection Agency Washington, DC: page 5.
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2006 Edition of the Drinking Water Standards and Health Advisories (EPA 822-R-06-013), Office of Water U.S. Environmental Protection Agency Washington, DC: page 5.
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7
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0038134866
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Determination of formaldehyde in cosmetics by HPLC method and acetyl acetone method
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P. Wu, C. Chang, and S. Chou. Determination of formaldehyde in cosmetics by HPLC method and acetyl acetone method. Journal of Food and Drug Analysis 11(1): 8-15 (2003).
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Wu, P.1
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Chou, S.3
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0028179676
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HPLC determination of trace levels of aliphatic aldehydes C1-C4 in river and tap water using online preconcentration
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J. Lehotay and K. Hromulakova. HPLC determination of trace levels of aliphatic aldehydes C1-C4 in river and tap water using online preconcentration. J. Liq. Chromatography 17(3): 579-88 (1994).
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84996374278
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Gas chromatographic analysis of formaldehyde in fish-paste products
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K. Kido, T. Sakuma, and T. Watanabe. Gas chromatographic analysis of formaldehyde in fish-paste products. Eisei Kagaku 26, No. 5: 224-28 (1980).
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Kido, K.1
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Watanabe, T.3
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10
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33745570608
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Determination of aldehydes and ketones in natural gas combustion in the ppb range by high-performance liquid chromatography
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H. J. Goetze and S. Harke. Determination of aldehydes and ketones in natural gas combustion in the ppb range by high-performance liquid chromatography. Fresenius' J. Anal. Chem. 335(3): 286-288 (1989).
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Gas chromatographic determination of trace amounts of formaldehyde in aqueous extracts and model mixtures simulating foods
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A.L. Pertsovskii and L.M. Kremko. Gas chromatographic determination of trace amounts of formaldehyde in aqueous extracts and model mixtures simulating foods. Zh. Anal. Chem. 40(6): 1115-18 (1985).
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Pertsovskii, A.L.1
Kremko, L.M.2
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12
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0029111847
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HPLC method development and validation for formaldehyde in enteric coating of hard gelatin capsules
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E. Pina, A.T. Sousa, and P. Brojo. HPLC method development and validation for formaldehyde in enteric coating of hard gelatin capsules. J. of Liq. Chromatography 18(13): 2683-93 (1995).
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13
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0024429527
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Micoanalysis of aldehydes in 1% lauromacrogol injections
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Y. Kato, K. Akiyama, S. Kohchi, S. Shinhachiro, Y. Masaaki, and T. Yokoyama. Micoanalysis of aldehydes in 1% lauromacrogol injections. Byoin Yakugaku. 15(5): 332-35 (1989).
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Shinhachiro, S.4
Masaaki, Y.5
Yokoyama, T.6
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14
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0000877596
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Separation and quantitative determination of carbonyl compounds as their 2,4-dinitrophenylhydrazones by high-pressure liquid chromatography
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S. Selim. Separation and quantitative determination of carbonyl compounds as their 2,4-dinitrophenylhydrazones by high-pressure liquid chromatography. J. Chromatogr. 136: 271-77 (1977).
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Selim, S.1
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15
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Determination of nanogram amounts of carbonyls as 2, 4-dinitrophenylhydrazones by high-performance liquid chromatography
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K. Fung and D. Grosjean. Determination of nanogram amounts of carbonyls as 2, 4-dinitrophenylhydrazones by high-performance liquid chromatography. Anal. Chem. 53(2): 168-71 (1981).
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16
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Three Approaches to the Analysis of Trace Formaldehyde in Bulk and Dosage Form Pharmaceuticals
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G. Manius, L. Wen, and D. Palling. Three Approaches to the Analysis of Trace Formaldehyde in Bulk and Dosage Form Pharmaceuticals. Pharm. Res. 10(3): 449-53 (1993).
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