Easy compliance with USP Chapter <857>

US Pharmacopoeia Chapter <857> was published in 2015 and is mandatory from May 1st 2016.  It calls for UV-visible spectrophotometers to be qualified on a regular basis using defined test materials and procedures, some of which are new to the USP. While it is possible for instrument users to prepare their own test materials, Chapter <857> states: “Wherever possible…..Certified Reference Materials (CRMs) are to be used in preference to laboratory-prepared solutions.”  Starna Scientific has introduced new Certified Reference Materials designed to enable laboratories to comply with these revised regulations.

Ultraviolet instruments must now be qualified for resolution (bandwidth) in addition to absorbance accuracy, wavelength accuracy and stray light, and a new stray light test uses different materials and procedures from those previously recommended. Starna CRM sets comply fully with these new requirements, and also offer cost savings compared to purchasing individual references. For method validation, USP <857> recommends that absorbance linearity is checked with five or more analyte concentrations; Starna linearity CRM sets allow the instruments to be verified to this standard.

CRM sets are also available for visible spectrophotometers and for those working to European Pharmacopoeia requirements. Starna Combined Instrument Qualification Sets cover both USP and EP and are ideal for support and service organisations.