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General Chapter Prospectus: <197> Spectroscopic Identification Tests

Type of Posting: General Announcement

Posting Date: 25–Mar–2016

Archive Date: 24–Jun–2016

Expert Committee: General Chapters—Chemical Analysis

Input Deadline: 25–Apr–2016

Current or Proposed GC Title: <197> Spectroscopic Identification Tests

Suggested audience: Suppliers and manufactures of drug substance, drug products, excipients, dietary supplements and drug testing organizations and drug products related regulatory agencies.

Estimated proposal PF: 42 (5)

Background and objective(s): As part of the initiative to revise the general chapters covering spectroscopy and owing to the scientific and technological advancements in the field of spectroscopy, the General Chapters—Chemical Analysis Expert Committee recommends updating General Chapter <197> Spectrophotometric Identification Tests. The updated General Chapter information and style will be consistent with the other general chapters on spectroscopy and will reflect the state of the art and the best current practices in the industry.

Preliminary outline: The following represents the proposed major changes for the General Chapter

  • Title change to Spectroscopic Identification Tests
  • A new Introduction is proposed to be added.
  • A new section, Identification Methodology is proposed to be added
  • A section heading change from the Infrared Absorption to Infrared Spectroscopy
  • Technical and editorial revisions for the newly titled Infrared Spectroscopy section. The main technical revision for this section consist in allowing the comparison of the spectrum of the test specimen to the spectrum of the official lot of reference standard previously recorded
  • A section heading change from Ultraviolet Absorption to Ultraviolet-Visible Spectroscopy
  • A new section, Near Infrared and RAMAN Spectroscopy is proposed to be added
  • A new section, Equivalent/Alternative Tests is proposed to be added

Contact: Edmond Biba, Ph.D., (301-230-3270,