|Potassium Dichromate 60 mg/l & blank cell||Photometric Accuracy||235-350 nm|
|Potassium Dichromate 600 mg/l||Photometric Accuracy||430 nm|
|Holmium Oxide Solution cell||Wavelength Accuracy||240-640 nm|
|Potassium Chloride 10 mm cells & blank cell||Stray Light||190-205 nm|
|Toluene in Hexane & blank cell||Resolution||267-269 nm|
In a regulated environment, the responsibility of proof is on the user to justify and demonstrate, by the qualification of the system, that a spectrophotometer is ‘fit for purpose’ and capable of providing the required accuracy and precision of data.
Based on many years experience, Starna has developed sets of Certified Reference Materials, carefully selected to demonstrate compliance to national and international norms with confidence.
Sets are available to suit all needs, ranging from the user with just one instrument to large laboratories, quality control departments and support and service organizations. In addition to the convenience they provide, Starna CRM sets also offer cost savings when compared to the purchase of individual references.
USP Chapter <857>:
In May 2015 the US Pharmacopeia published a new Chapter <857> containing new instrument performance test specifications for ultraviolet and visible spectrophotometers. These become mandatory from 1st May 2016. New instrument qualification references from Starna allow laboratories to meet these new regulations.
The new chapter includes requirements for Operational Qualification (OQ) and Performance Qualification (PQ):
Operational Qualification (OQ) is required to demonstrate that the instrument under test is suitable for the intended use and analytical procedures for which it is employed.
Performance Qualification (PQ) requires that that it can be demonstrated on an ongoing basis that the instrument continues to meet that standard.
The new regulations for OQ and PQ require that laboratories can demonstrate to the regulatory authority that the spectrophotometric devices being used are qualified for wavelength and photometric accuracy, stray light and instrument resolution. New stray light and resolution tests are described that require the use of reference materials not previously specified by the USP.
It is also stated in Chapter <857> that Certified Reference Materials should be obtained from a recognized and accredited source, and have value assignments with associated calculated uncertainty. Certified values must be traceable to internationally recognized primary standards. The references must be periodically recertified to maintain validity of the certification.
Starna’s production and calibration facilities are accredited to ISO/IEC 17025 and ISO Guide 34, meeting all international standards and regulatory requirements. Starna can supply all the Certified Reference Materials required to meet the new regulations in convenient, ready to use sets.
There is also a pathway to upgrade an existing USP set if manufactured by Starna.
It may be possible to provide an upgrade for third party references, but this would need to be assessed on an individual basis. Please contact Starna for more information.
Many of the references recommended by the US Pharmacopeia are also suitable for working to the standards of regulatory authorities, such as the ASTM, European Pharmacopoeia and other national bodies.
Only Certified Reference Materials recommended by the European Pharmacopoeia for instrument qualification, and traceable to NIST, are supplied in these sets.
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