Easy compliance with USP Chapter <857>
Apr 13 2016 Read 1501 Times
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.
Do you like or dislike what you have read? Why not post a comment to tell others / the manufacturer and our Editor what you think. To leave comments please complete the form below. Providing the content is approved, your comment will be on screen in less than 24 hours. Leaving comments on product information and articles can assist with future editorial and article content. Post questions, thoughts or simply whether you like the content.
In this edition Articles - Detection of molecular markers in aquatic sediments by ion profi les obtained by GC/MS system - Fighting the Resistance: How Rapid Microbial ID with MALDI MS and A...
View all digital editions
Feb 20 2019 Mumbai, India
Feb 21 2019 New Delhi, India
Feb 25 2019 Moscow, Russia
Feb 26 2019 Guangzhou, China
Feb 27 2019 Berlin, Germany