European Pharmacopoeia 10.0 Chapter 2.2.25: Making reliable compliance simple! Suitable Certified Reference Materials for UV-Vis Spectrophotometer validation from Starna

Starna Scientific Ltd. (Hainault, UK) have extended their range of Spectrophotometer Certified Reference Materials (CRMs) to include convenient sets of references to cover all the parameters required for UV-Vis instrument qualification in the new European Pharmacopoeia 10.0 Chapter 2.2.25: wavelength accuracy, absorbance accuracy, linearity, stray light and instrument resolution.

The new Chapter 2.2.25 marks a signficant shift in emphasis compared to the previous version; with new requirements that users test their instrument fully over the “intended spectral range”. This means that a ‘one-size fits all’ approach used by many users previously is no longer sufficient to ensure data integrity. It is now necessary for users to ensure that they qualify the instrument under test, in the full wavelength and photometric ranges where they intend to make measurements.

In order to comply to the latest standard, users should ensure that the instrument they intend to use is suitable for the full wavelength and photometric ranges over which they will operate it and to select appropriate reference materials according to their specific measurement requirements.

For wavelength accuracy, a combined Holmium and Didymium reference (240 – 795nm) – also available individually, and a Cerium Oxide reference (200-270nm) provide coverage for much of the UV-Vis spectral wavelength range, with Starna TS8 reference (190-230nm) completing the line-up for users operating in the deep UV.

Extended absorbance series are now available in the following materials: Neutral Density filters (440-635nm up to 3.5 A); Potassium Dichromate (235-350nm up to 3.5 A); Nictonic Acid (210-260nm up to 2.5 A); and Starna Green (250-650nm up to 5 A). These enable users to check absorbance accuracy and linearity to the realistic absorbance limit of most standard instruments on the market.

The complete list of example references in the new standard for stray light checks – Potassium chloride, sodium iodide, potassium iodide and sodium nitrite – are readily available from Starna.

Toluene in Hexane remains as a principle method for confirming instrument resolution.

Starna Certified Reference Materials are suitable for use, where appropriate to the users requirements, in complying with the latest requirements of the new European Pharmacopoeia 10.0. All Starna CRMs are covered by the Starna Calibration Laboratory UKAS (United Kingdom Accreditation Service) accreditation to ISO/IEC 17025 for calibration, and ISO 17034 as a Reference Material Producer, with full traceability to NIST in the USA. Starna CRMs are widely used by leading pharmaceutical companies and instrument manufacturers. They are permanently sealed by heat-fusion alone and are covered by the unique Starna lifetime guarantee. For more information on the full range of Starna CRMs please click here.