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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.
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?
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.