What is standard reference?
A standard reference material (SRM) as defined by NIST “is a material or artifact that has had one or more of its property values certified by a technically valid procedure, and is accompanied by, or traceable to, a certificate or other documentation which is issued by NIST…
What are standard reference materials used for?
SRMs are used in a range of fields including environmental analysis, health measurements, industrial materials production and analysis, and general measurements within the realms of science and metrology.
What is the difference between reference material and certified reference material?
Certified Reference Materials are considered to provide the highest level of accuracy, uncertainty and traceability to an SI unit of measurement. Reference Materials are a rung down from Certified Reference Materials though still must be supplied by an accredited Reference Material Producer.
What is an analytical standard?
An analytical standard is a compound of high purity and known concentration to be used as a calibration standard for a given assay.
What is reference standard in pharma?
A pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products.
What are the types of reference standards?
Reference Standard identity and purity standards:
Metals impurity by inductively coupled plasma mass spectrometry (ICP-MS) Identification & structure confirmation by UV and/or IR spectroscopy. Chromatographic purity by using HPLC. Residual solvents by Headspace gas chromatography (HSGC-FID)
What is a reference standard in pharma?
What is the difference between reference and standard?
The Terms of Reference only relate to one project and are more about defining the goals and boundaries. Standard procedures are accepted ways of doing things for an organization at all times and don’t change from project to project.
What is difference between working standard and reference standard?
“A reference standard (i.e., primary standard) may be obtained from the USP/NF or other official sources (e.g., CBER, 21 CFR 610.0). A working standard (i.e., in-house or secondary standard) is a standard that is qualified against and used instead of the reference standard.”
What are reference standards for impurities?
A real impurity reference standard should provide identity evidence, i.e. spectra and information on how they were used for proving identity, at least comprising a short formal sentence that on request can be elaborated into a full identity interpretation report.
What are reference standards in pharma?
What is reference standard as per USP?
USP Reference Standards are integral components of monographs and other documentary standards established by USP to help ensure the identity, strength, quality, and purity of medicines and foods, and are provided primarily for quality control use in conducting the assays and tests in these documentary standards.
What are primary reference standards?
A primary standard reference material is an ultra high purity grade compound used in analysis involving assay, identification or purity tests. It can be a single compound or a mixture having the analyte of interest in a specified and certified amount.