Tuesday, 4 October 2016

Pharmacopeial Forum 42 (4)


A new edition of the Pharmacopeial Forum Vol. 42, No.4, has been issued. Items of interest include:

Chapter 785 Osmolality and Osmolarity

Proposed revision details:
  • Add clarity to the text in the Introduction.
  • Add examples of how to convert from osmolality to osmolarity.
  • Add information about the shelf life of Standard Solutions in Measurement of Osmolality, Standard Solutions.
  • Add tolerances for the amounts of sodium chloride (NaCl) in Measurement of Osmolality, Standard Solutions and how they should be prepared.
  • Update instructions on how to evaluate repeatability in the osmometer calibration.
  • Include information about possible suppliers of commercially available standard solutions used in the osmometer calibration.
Additionally, minor editorial changes have been made to update the chapter to current USP style.

Chapter 857 Ultraviolet-Visible Spectroscopy

Proposed revision details:
  • Introduction: Clarification on the type of equipment covered and not covered by this chapter.
  • Control of Wavelengths: Inclusion of possible procedures and clarification of the acceptance criteria.
  • Control of Absorbance: Inclusion of the procedures and acceptance criteria for the regions of 0–1 A and 1–3 A; update of the National Institute of Standards and Technology (NIST) documents referenced; and inclusion of tabulated values of absorptivity for potassium dichromate solutions. Clarification of the acceptance criteria for neutral-density glass filters.
  • Limit of Stray Light: Inclusion of two procedures for measuring stray light.
  • Resolution: Inclusion of a more detailed procedure to evaluate this parameter.
  • Validation, Quantitation Limit: Update of the ASTM document referenced.
  • Validation, Linearity: Replacement of correlation coefficient R with r2.
  • Validation, Robustness: Inclusion of the statement that this parameter is evaluated during method development

Chapter 1079.1 Storage and Transportation of Investigational Drug Products [NEW]

Chapter 1857  Ultraviolet-Visible Spectroscopy – Theory and Practice

Changes include: 
  • Analytical Considerations, Instrumental Factors, Spectral Bandwidth, inclusion of the use of the atomic deuterium line to confirm the spectral bandwidth.
  • Analytical Considerations, Instrumental Factors, Stray Light, inclusion of additional information and discussion on the effects of stray light.
  • Analytical Considerations, Sampling Factors, Cell Corrections, changing the title of this subsection to “Cell Matching Corrections.


Posted by Dr. Tim Sandle

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