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Organic Process Research and Development

Volumn 13, Issue 3, 2009, Pages 409-

Letters to the editor: Genotoxic impurities in drug substances

(1) Snodin, David a

a PAREXEL INTERNATIONAL (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 66249127579 PISSN: 10836160 EISSN: 1520586X Source Type: Journal
DOI: 10.1021/op900043v Document Type: Letter

Times cited : (9)

References (13)

1
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- Guideline on the limits of genotoxic impurities: http://www.emea.europa. eu/pdfs/human/swp/519902en.pdf.
- Guideline on the limits of genotoxic impurities

2
- 84948672326
- Genotoxic and carcinogenic impurities in drug substances and products: recommended approaches: http://www.fda.gov/cder/guidance/7834dft.pdf.
- Genotoxic and carcinogenic impurities in drug substances and products: Recommended approaches

3
- 84961905606
- Hazardous Substances Database (HSDB): http://toxnet.nlm.nih.gov/cgi-bin/ sis/htmlgen?HSDB.
- Hazardous Substances Database (HSDB)

4
- 0024559782
- Two-year drinking-water study of formaldehyde in rats
- Til, H. P.; Woutersen, R. A.; Feron, V. J.; Hollanders, V. H.; Falke, H. E.; Clary, J. J. Two-year drinking-water study of formaldehyde in rats. Food Chem. Toxicol. 1989, 2, 77-87.
- (1989) Food Chem. Toxicol , vol.2 , pp. 77-87
- Til, H.P.¹ Woutersen, R.A.² Feron, V.J.³ Hollanders, V.H.⁴ Falke, H.E.⁵ Clary, J.J.⁶

5
- 66249097295
- EPA Integrated Risk Information System, Formaldehyde: http://www.epa.gov/iris/subst/0419.htm.
- EPA Integrated Risk Information System, Formaldehyde

6
- 66249111748
- Formaldehyde. Concise International Chemical Assessment Document 40: http://www.inchem.org/documents/cicads/cicads/cicad40.htm.
- Formaldehyde. Concise International Chemical Assessment Document 40: http://www.inchem.org/documents/cicads/cicads/cicad40.htm.

7
- 66249118251
- Toxicological profile for formaldehyde. Agency for Toxic Substances and Disease Registry: http://www.atsdr.cdc.gov/toxprofiles/tp111.pdf.
- Toxicological profile for formaldehyde. Agency for Toxic Substances and Disease Registry

8
- 66249118931
- Assessment of the carcinogenicity of formaldehyde. Bundesinstitut für Risikoberwertung: http://www.bfr.bund.de/cm/238/assessment-of- the-carcinogenicity-of-formaldehyde.pdf.
- Assessment of the carcinogenicity of formaldehyde. Bundesinstitut für Risikoberwertung

9
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- International Programme on Chemical Safety
- International Programme on Chemical Safety. Environmental Health Criteria 196. Methanol: http://www.inchem.org/documents/ehc/ehc/ehc196.htm.
- Environmental Health Criteria 196. Methanol

10
- 66249142219
- Impurities. Residual Solvents. ICH Topic Q3C(R3): http://www.emea. europa.eu/pdfs/human/ich/028395en.pdf.
- Impurities. Residual Solvents. ICH Topic Q3C(R3)

11
- 55749109196
- Your prodrug releases formaldehyde: Should you be concerned?
- Dhareshwar, S. S.; Stella, V. J. Your prodrug releases formaldehyde: should you be concerned? No. J. Pharm. Sci. 2008, 10, 4184-4193.
- (2008) J. Pharm. Sci , vol.10 , pp. 4184-4193
- Dhareshwar, S.S.¹ Stella, V.J.²

12
- 84881142606
- Guideline on the specification limits for residues of metal catalysts or metal reagents: http://www.emea.europa.eu/pdfs/human/swp/444600enfin.pdf.
- Guideline on the specification limits for residues of metal catalysts or metal reagents

13
- 66249136618
- Specifications for Class 1 and Class 2 residual solvents in active substances
- Specifications for Class 1 and Class 2 residual solvents in active substances: http://www.emea.europa.eu/pdfs/human/qwp/045003en.pdf.

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.