“Qualify your UV-Visible spectrophotometer to the New USP <857>”

New Starna USP Qualification kits, to assist compliance with the new USP <857> chapter

The new Starna USP kits provide all the appropriate liquid reference materials, in a permanently heat-fused sealed format, so that the required parameter verification to specific instrumental requirements can easily be performed.

Between 2010 and 2015, the Spectroscopy sub-committee, of the General Chapters, Chemical Analysis Expert Committee of the United States Pharmacopeia (USP) was tasked to extensively revise and update the Spectroscopy <851> chapter.

The original chapter, whilst covering the general spectroscopic principles, did not provide sufficient guidance with respect to the specific, and discrete techniques in use in modern laboratories.

Therefore, the current revision has resulted in a suite of technique specific General Chapters, of which the Ultraviolet Visible Spectroscopy chapter <857> is one. These are to be implemented from 1 May 2015.

As a mandatory chapter, it details how the essential Qualification requirements regarding the key parameters of wavelength accuracy, photometric accuracy/linearity, Stray Light, and resolution, must be met on a UV-Visible spectrophotometer.

The New USP requirement to qualify the Stray Light and resolution characteristics, provide a significant degree of harmonisation with the requirements of the other major pharmacopoeias.

In addition, the Stray Light section in this chapter adopts the published protocols found in ASTM International standard E387 “ Standard Test Method for Estimating Stray Radiant Power Ratio of Dispersive Spectrophotometers by the Opaque Filter Method ”. This uses a combination of 5 mm and 10 mm path length cuvettes, filled with the same ‘cut-off’ solution.

All the new references are manufactured and calibrated by Starna Scientific; UKAS Accredited to both ISO Guide 34 (4001) as a Reference Material producer, and ISO 17025 (0659) as a Calibration Laboratory for optical reference measurements. Starna Scientific’s manufacturing facility is also accredited to the ISO 9001 Quality Management System with BSI.

A Certificate of Calibration and Traceability and full instructions for use are provided with each Reference Material. The certificate is supplied in electronic format, on a USB drive in the same box as the references, allowing hard copy to be produced on demand and giving easy interface to the user’s own IT systems. Certification measurements are made on a reference spectrophotometer that has been qualified using Standard Reference Materials certified by the National Institute of Standards and Technology (NIST) in the USA, or against primary physical references such as elemental emission lines.

Starna offers a Lifetime Guarantee on all Starna Certified Reference Materials, unless otherwise stated, such that any reference material that moves outside its published uncertainty budget will be replaced free of charge. This guarantee is subject to the reference materials being re-certified at least every two years by Starna and that the references have not been physically, thermally or optically abused. The Starna UKAS accredited calibration laboratory aims to re-certify and despatch references within five working days from receipt.