Skip to main content

Venlafaxine Hydrochloride Extended-Release Capsules

Type of Posting: Revision Bulletin

Posting Date: 28–Sep–2012

Official Date: 01–Oct–2012

Archive Date: 09–Feb–2015

Expert Committee: Monographs—Small Molecules 4

Reason for Revision: Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised Venlafaxine Hydrochloride Extended-Release Capsules monograph. The purpose for the revision is to:

  • Add Dissolution Tests 4, 5, 6, 7, and 8 for products approved by the FDA.
  • Under Dissolution Test 1, add a dilution step for the Sample solution and revise the calculation to include a dilution factor.
  • Clarify that the solution withdrawn in Dissolution Test 3 as Sample solution is replaced with an equal volume of Medium at each time interval.
  • Update the chemical name and information for USP Venlafaxine Related Compound A RS in the Reference Standards section to reflect that it is available as a hydrochloride salt.

The liquid chromatographic procedure in the test for Dissolution, Test 4 is based on analyses performed with a Kromasil C8 brand of L7 column, manufactured by Merck/AkzoNobel. The typical retention time for venlafaxine is about 4 min.

The liquid chromatographic procedure in the test for Dissolution, Test 5 is based on analyses performed with a Hypersil BDS C8 brand of L7 column, manufactured by Thermo Scientific. The typical retention time for venlafaxine is about 5.5 min.

The liquid chromatographic procedure in the test for Dissolution, Test 6 is based on analyses performed with the Inertsil ODS-3 and Luna C18 brands of L1 column, manufactured by GL Sciences and Phenomenex, respectively. The typical retention time for venlafaxine is about 4.7 min.

The liquid chromatographic procedure in the test for Dissolution, Test 7 is based on analyses performed with an Inertsil ODS-3V C18 brand of L1 column, manufactured by GL Sciences. The typical retention time for venlafaxine is about 4.3 min.

The liquid chromatographic procedure in the test for Dissolution, Test 8 is based on analyses performed with an ACE 5 C18 brand of L1 column, manufactured by ACE. The typical retention time for venlafaxine is about 7 min.

This Venlafaxine Hydrochloride Extended-Release Capsules Revision Bulletin supersedes the currently official monograph which was posted as a Revision Bulletin on December 29, 2011 and became official on July, 1, 2012. The Revision Bulletin will be incorporated in the First Supplement to USP 36–NF 31.

Should you have any questions, please contact Heather Joyce, Ph.D. (301-881-0666 x8442, hrj@usp.org) or Ravi Ravichandran, Ph.D (301-816-8330, rr@usp.org).