International Conference impurity guidelines

HHS/FDA International Conference on Harmonisation, Guidelines Availability Impurities in New Drug Substances Notice, Federal Register, January 4, 1996 An FDA Perspective on Bulk Pharmaceutical Chemicals, Edmund M. Fry, Pharmaceutical Technology, February 1984, Pages 48-53... 

ICH (2005) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Impurities Guideline for... 

International Conference of Harmonization Q3B (R), Impurities in New Drug Products (Revised Guideline), Federal Register 68,2003. 

The long-term stability of an oral liquid formulation can also be affected by a number of unexpected reasons. Contamination by solvents used during the tank cleaning or even in the manufacture of excipients or API can be a source of instability of an oral solution. Uncontrolled levels of Class I, II, or III solvents could lead to the rejection of a batch or an excipient vendor. Class III solvents have a permitted daily exposure of 50 mg or less per day. (See the International Conferences on Harmonization, Impurities Guidelines for Residual Solvents. Q3C, Federal Register 1997 62(247) 67377 and also http //www.fda.gov/cvm/Guidance/guidelOO.PDF). 

List taken from International Conference on Harmonization (ICH), harmonized tripartite (Europe, Japan, United States) guideline entitled Impurities Guideline for Residual Solvents. The above solvents are categorized as Class 3 solvents, with low toxic potential to man. Class 3 solvents have permitted daily exposures (PDEs) of 50 mg or more per day. 

International Conference on Harmonization (1996). Guideline on Impurities in New Drug Products. Federal Register 61, 371-376. 

ICH Q3C Gnidance (International Conference on Harmonisation). Impurities Guideline for Residual Solvents, 2011. 

Harmonization of requirements has successfully been made by the International Conference on Harmonisation (ICH), e.g., in guidelines on stability documentation, method validation, and investigation of impurities. Regarding impurities information is given on how the limits should be set and at what level identification is needed. Similar efforts are seen for dissolution testing and how to correlate in vivo and in vitro data. The question of bioavailability and bioequivalence is an important one and has been dealt with as well. As a consequence of the rapid development in chiral separations we can now see a harmonization of requirements also for chiral drugs. 

ICH QG (2009) International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use impurities guideline for residual solvents q3c(r4). http //westpalmbeachanalytic.homestead.com/Q3C R4 Guide Res Solv.pdf. Ac-... 

ICH-Q3(R5) Guideline (2011) International conference of harmonization, tripartite guideline, impurities guideline for residual solvents... 

International Conference on Harmonisation (2006) ICH Harmonised Tripartite Guideline Impurities in New Drug Substances- Q3A(R2). 

---