Changes in USP and Ph. Eur. | UV Vis Compliance | Qualification Solution

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Pharmacopeia Changes – What to Be Checked on UV Vis Spectrometer?

The Changes (e.g. Photometric Linearity) in the Chapter on UV Vis Absorption Spectrophotometry of USP and Ph. Eur., and the Consequences on Performance Qualification of Spectrophotometers

Pharmacopoeias are published by regulatory bodies and define guidelines on the procedures and analytical instrumentation for the preparation and analytical measurement of pharmaceutical products. Both the US and European Pharmacopoeias, USP and Ph. Eur. respectively, have a dedicated chapter on the requirements of UV Vis spectrophotometers and the qualification of their performance. The chapter was revised in 2019 and pharmaceutical companies are facing the challenge of accordingly adapting their workflow. METTLER TOLEDO has adapted the automated performance qualification accessories so that the compliance of all customers is maintained.

Learn more about the changes in USP and Ph. Eur. and ensure your UV Vis spectrometer complies.


Learning outcomes of this webinar:

  • Know the changes in the respective optical chapters of USP 42 – NF37 2nd and Ph. Eur. 10, such as how the photometric linearity test is defined, and what changes are introduced for the photometric accuracy tests and how to perform the tests.
  • Know the consequences on optical performance qualification of UV Vis spectrophotometers
  • Benefits of automated performance qualification against manual execution
  • Positive aspects of using certified liquid reference materials
  • Solution for data integrity compliance in optical instrument qualification.

When do the changes in USP and Ph. Eur. respectively take effect?

The revised optical chapter 2.2.25 in the 10th edition of the European Pharmacopeia and the revised optical chapter 857 of the USP 42NF37 became mandatory on January 1st 2020.


What was changed in the UV Vis spectroscopy chapter of USP and Ph. Eur. respectively?

  • The determination of the photometric linearity becomes mandatory in both Pharmacopeias
  • In the newest edition 42 NF37 of the USP the stray light test according to procedure B, which is the specific wavelength method, is accepted in addition to the procedure A, which is the solution filter ratio method.
  • In the newest issues of both Pharmacopeias, the use of nicotinic acid for photometric accuracy and linearity qualification in the UV region, in addition to the hitherto used potassium dichromate, is permitted.
  • Both Pharmacopeias demand for the qualification of the same optical parameters. The only exception is the test of the photometric precision (i.e. photometric repeatability), which is only required by the United States Pharmacopeia for scanning spectrophotometers.  

What certified reference materials (CRMs) are specified for wavelength accuracy and precision tests by both Pharmacopeias?

USP: Rare earth oxide solutions/glasses (Ce, Ho) or Hg/D2 emission lines

Ph. Eur.: Ho(ClO4)3, Ce2(SO4)3 solutions, or Ho/Didymium glasses, or Hg, D2, Ne, Xe lines


What CRMs are specified for photometric accuracy and precision tests by both Pharmacopeias?
USP: for UV range, Nicotinic acid in HCl (6 – 60 mg/L, up to 2.5 A, 213 and 261 nm) or K2Cr2O7 in HClO4 (6 – 200 mg/L, up to 3.0 A, 235, 257, 313, 350 nm); for visible range, neutral density glass filters (up to 3.5 A, 440, 465, 546.1, 590, and 635 nm)

Ph. Eur.: Suitable solid and liquid filters such as certified PDC or neutral density filters; or, instead of certified PDC, Nicotinic acid in HCl.


What CRMs are specified for photometric linearity tests by both Pharmacopeias?

USP and Ph. Eur., respectively, specify to use the materials for photometric accuracy tests also for photometric linearity tests.