General Methods

Updated October 26, 2012

Q-01    Dissolution
USP Title: <711> Dissolution
USP Expert Committee (2010–2015): General Chapters—Dosage Forms
USP Scientific Liaison: William Brown
Lead PDG Pharmacopeia: USP
Current PDG version: Revision 3

• PDG sign-off: 09–Jun–2010
• USP Stage 4 PF: N/A
• USP Stage 6 PF or posting date: 25–Feb–2011

Q-02    Disintegration
USP Title: <701> Disintegration
USP Expert Committee (2010–2015): General Chapters—Dosage Forms
USP Scientific Liaison: William Brown
Lead PDG Pharmacopeia: USP
Current PDG version: Revision 1

• PDG sign-off: 30–Oct–2007
• USP Stage 4 PF: 28(5)
• USP Stage 6 PF or posting date: Official in USP31–NF26 (not published at Stage 6)

Q-03/04    Uniformity of Content/Mass
USP Title: <905> Uniformity of Dosage Units
USP Expert Committee (2010–2015): General Chapters—Dosage Forms
USP Scientific Liaison: William Brown
Lead PDG Pharmacopeia: USP
Current PDG version: First

• PDG sign-off: 15–Jun–2011
• USP Stage 4 PF: 34(5)
• USP Stage 6 PF or posting date: 25–Feb–2011

Q-05a    Tests for Specified Microorganism
USP Title: <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
USP Expert Committee (2010–2015): General Chapters—Microbiology
USP Scientific Liaison: Rahdakrishna Tirumalai
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1

• PDG sign-off: 05–Jun–2008
• USP Stage 4 PF: 29(5)
• USP Stage 6 PF or posting date: 34(6)

Q-05b    Microbial Enumeration
USP Title: <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
USP Expert Committee (2010–2015): General Chapters-Microbiology
USP Scientific Liaison: Rahdakrishna Tirumalai
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1, Correction 1

• PDG sign-off: 10–Jun–2009
• USP Stage 4 PF: 29(5)
• USP Stage 6 PF or posting date: 34(6), erratum 35(4)

Q-05c    Limits for Non-sterile Products
USP Title: <1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
USP Expert Committee (2010–2015): General Chapters—Microbiology
USP Scientific Liaison: Rahdakrishna Tirumalai
Lead PDG Pharmacopeia: EP
Current PDG version: First

• PDG sign-off: 08–Nov–2005
• USP Stage 4 PF: 29(5)
• USP Stage 6 PF or posting date: 33(2)

Q-06    Bacterial Endotoxins
USP Title: <85> Bacterial Endotoxins Test
USP Expert Committee (2010–2015): General Chapters—Microbiology
USP Scientific Liaison: Rahdakrishna Tirumalai
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 2

• PDG sign-off: 15–Jun–2011
• USP Stage 4 PF: N/A
• USP Stage 6 PF or posting date: 23–Nov–2011; Official 01–Dec–2012

Q-07    Color (instrumental method)
USP Title: <1061> Color-Instrumental Measurement
USP Expert Committee (2010–2015): General Chapters—Physical Analysis
USP Scientific Liaison: Antonio Hernandez-Cardoso
Lead PDG Pharmacopeia: EP
Current PDG version: Not signed off

• PDG sign-off: N/A
• USP Stage 4 PF: N/A
• USP Stage 6 PF or posting date: N/A

Q-08    Extractable Volume
USP Title: <1> Injections
USP Expert Committee (2010–2015): General Chapters—Dosage Forms
USP Scientific Liaison: Desmond Hunt
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1

• PDG sign-off: 09–Nov–2010
• USP Stage 4 PF: N/A
• USP Stage 6 PF or posting date: 33(2) IRA, local revision in 35(5)

Q-09    Particulate Contamination
USP Title: <788> Particulate Matter in Injections
USP Expert Committee (2010–2015): General Chapters—Dosage Forms
USP Scientific Liaison: Desmond Hunt
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1

• PDG sign-off: 09–Nov–2010
• USP Stage 4 PF: N/A
• USP Stage 6 PF or posting date: 33(2) IRA, RB 01–Apr–2007

Q-10    Residue on Ignition
USP Title: <281> Residue on Ignition
USP Expert Committee (2010–2015): General Chapters—Physical Analysis
USP Scientific Liaison: Horacio Pappa
Lead PDG Pharmacopeia: JP
Current PDG version: Revision 2

• PDG sign-off: 04–Aug–2005
• USP Stage 4 PF: 29(2)
• USP Stage 6 PF or posting date: 31(5)

Q-11    Sterility Test
USP Title: <71> Sterility Tests
USP Expert Committee (2010–2015): General Chapters—Microbiology
USP Scientific Liaison: Rahdakrishna Tirumalai
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1, Correct 3

• PDG sign-off: 10–Jun–2009
• USP Stage 4 PF: 33(3)
• USP Stage 6 PF or posting date: 34(6), erratum 36(4)