What are USP reference standards?
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.
How do you reference USP?
For general references, USP recommends using the name/title of the standard, e.g., the name of the monograph or General Chapter.
Where can I find USP standards?
USP’s mission is “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.” Standards for an article recognized in a USP compendium are expressed in the article’s monograph, the General Notices, and applicable general chapters (such …
What is the storage condition for reference standard?
Storage conditions are lot-specific and may change from one lot to another. If no specific directions or limitations are provided on the RS label, the conditions of storage shall include storage at room temperature and protection from moisture, light, freezing, and excessive heat.
How do you write a reference standard?
The reference standard materials are usually prepared according to the following rules:
- Fully characterized high purity neat materials and high purity diluents.
- Careful assignment of chromatographic purity by multiple methods.
- Analysis of residual impurities including water, inorganics and solvent.
What is reference standard and working 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 is a USP code?
The shortcut USP comes from United States Pharmacopeial convention. Every kind of material or phase has a USP code. It is a general grouping for materials and the differences between materials with similar modifications are excluded.
What is basic reference standard?
A reference standard for a unit of measurement is an artifact that embodies the quantity of interest in a way that ties its value to the reference base. At the highest level, a primary reference standard is assigned a value by direct comparison with the reference base.
What is standard reference?
any one of the substances (materials) with precisely known and officially certified values of variables peculiar to a given substance. Standard reference materials quantitatively characterize the content of isotopes, elements, and compounds.
What is working reference standard?
How many USP Reference standards are there in the world?
USP currently offers more than 3,500 Reference Standards—highly characterized specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators. USP Reference Standards are specified for use in conducting official USP–NF tests and assays.
Do you need CoAs for USP Reference standards?
USP does not provide COAs. USP does provide USP Certificates for most USP Reference Standards (RS). USP Certificates do not completely describe the test results obtained during evaluation.
How are USP Reference Standards tested and reproducible?
USP Reference Standards are rigorously tested and evaluated by multiple independent commercial, regulatory, and academic laboratories to confirm accuracy and reproducibility. We offer the only publicly available, official documentary standards for pharmaceutical ingredients in the USP–NF that link directly with…
Can a USP Reference be used in a non-USP application?
USP Reference Standards are intended only for use in analytical or laboratory applications generally as specified in USP compendia. It may be possible to use a USP RS outside of its associated USP compendial applications; however, it is the responsibility of the user to determine the suitability of the RS for a non-USP use.