Drug reference standard

A drug reference standard is a standardized substance which is used as a measurement base for similar substances. Where the exact active substances of a new drug are not known, a reference standard provides a calibrated level of biological effects against which new preparations of the drug can be compared. drug reference solutions and patient education materials put the best available information into the hands of clinicians and patients. They supply critical information regarding dosage, efficacy, interactivity and allergies, even suggesting alternate therapies as appropriate. Drug reference Standards are highly characterized physical specimens used in testing by pharmaceutical and related industries to help ensure the identity, strength, quality, and purity of medicines (drugs, biologics, and excipients), dietary supplements, and food ingredients. Our Reference Standard collection consists of more than 3,100 items ranging from drug substances, related impurities, residual solvents, biologics, excipients, botanicals, polymers, Near-IR and dissolution calibrators, photomicrographs, and melting point standards. As a supplier of drug and metabolite standards for over 30 years, we are continually updating our drug standard offering to keep up with the demand of new analyses performed by toxicological and forensics laboratories. Our drug standards are available in three convenient formats. All chromatographic reference standards are supplied with a certificate of analysis certifying the identification and purity of the compound.

Standard (metrology)

In metrology (the science of measurement), a standard (or etalon) is an object, system, or experiment that bears a defined relationship to a unit of measurement of a physical quantity. Standards are the fundamental reference for a system of weights and measures, against which all other measuring devices are compared. Historical standards for length, volume, and mass were defined by many different authorities, which resulted in confusion and inaccuracy of measurements. Modern measurements are defined in relationship to internationally-standardized reference objects, which are used under carefully controlled laboratory conditions to define the units of length, mass, electrical potential, and other physical quantities.

Hierarchy of standards

There is a three-level hierarchy of physical measurement standards. At the top of the tree are the master standards - these are known as primary standards. Primary standards are made to the highest metrological quality and are the definitive definition or realization of their unit of measure. Historically, units of measure were generally defined with reference to unique artifacts which were the legal basis of units of measure. A continuing trend in metrology is to eliminate as many as possible of the artifact standards and instead define practical units of measure in terms of fundamental physical constants, as demonstrated by standardized technique. One advantage of elimination of artifact standards is that inter-comparison of artifacts is no longer required. Another advantage would be that the loss or damage of the artifact standards would not disrupt the system of measures.