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2nd November 2020 Content supplied by: NSI Lab Solutions
Trust NSI, a Leader in ISO-Certified Secondary Reference Standards
A reference-standard material is a highly purified compound that is well characterized and used to establish qualitative data, quantitative data, and calibration information.
The quality and purity of the reference standards are crucial for validating analytical results. When primary standards for reference materials are not available through compendial sources, a non-compendial (secondary) reference standard must be established by comparison with a reflective primary standard. These standards may be used for routine quality control purposes in place of primary standards, provided the use is established with reference to the primary standard. A secondary standard is established and employed to reduce the use of the more exhaustively evaluated primary standard, which may be in limited supply, or is cost-prohibitive. Secondary reference standards are created through a material qualification program developed by an accredited reference material manufacturer like NSI.
NSI Lab Solutions is an ISO Guide 34 accredited manufacturer of USP secondary reference materials. As with compendial reference materials, the quality and purity of secondary reference standards are crucial to determining scientifically valid results for many pharmaceutical analytical methods. NSI Lab Solutions INC offers ISO-certified secondary reference standards for numerous active pharmaceutical ingredients (APIs) and excipients.
NSI begins the process by determining the essential parameters for qualification. These parameters always include analytical methods for identity and purity of the candidate secondary reference material being characterized. The analytical methods used to identify and characterize the secondary reference material are chosen strategically, based upon the material type and its intended use. These methods include the use of MS, FTIR, HPLC, GCMS, melting/boiling point determination, and titration. NSI works closely with the customer to ensure the secondary reference standard is suitable for and certified according to the way it will be used.
NSI Lab Solutions takes pride in its product quality and customer service. NSI certifies and packages every secondary reference material in-house within our FDA registered facility in Raleigh, North Carolina, allowing us to provide industry-leading technical support to end-users of the products.
For more information on NSI secondary reference standards please click the green "Request Information" button below.
Date Published: 2nd November 2020
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