What is a reference standard 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.

Which standard is known as reference standard?

Establishment of a Reference Standard. A reference standard is a prerequisite to measuring potency. To measure potency, a sample of unknown potency must be compared to a standard of known potency, so that the potency ratio can be calculated.

What are reference standards?

Reference standards are used to determine quantitative data (such as assay and impurity), qualitative data (such as identification test), and calibration (such as melting point standard). Therefore, the quality and purity of the reference standards are crucial to achieve scientifically valid results.

How do you qualify a reference standard?

The reference standard should be of the highest purity possible; the drug substance may require further purification to become a reference standard (additional purification steps used for a drug substance should be fully described and included in any regulatory filing).

What is the current USP?

The current version of USP–NF standards deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. The current version, USP–NF 2021, Issue 1, will become official on May 1, 2021.

What is USP guidelines?

USP is a scientific nonprofit organization that sets public standards for identity, strength, quality and purity of medicines. USP standards are recognized in various provisions of the federal Food, Drug and Cosmetic Act (FDCA) and in laws, regulations and policies promulgated by states.

What is the difference between primary 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 is difference between working standard and reference standard?

Reference standards and working standards are same thing and reference standards are of higher quality or precision and we use these standards very little whereas working standards are of lower precision and we use them in our daily routine. Normally, reference standards are used to calibrate the working standards.

What is a reference standard test?

The reference standard is the test, combination of tests, or procedure that is considered the best available method of categorising participants in a study of diagnostic test accuracy as having or not having a target condition.

How do you calculate purity of reference standards?

The purity of the standard is calculated to 95.55% (purity = 100% – (2.5% x 0.98) – 2%).

Do you need CoAs for USP Reference standards?

USP does not provide Certificates of Analysis (COAs) for USP Reference Standards (RS). USP does provide USP Certificates for most USP RS’s. USP Certificates do not completely describe the test results obtained during evaluation. Rather, they a re issued to

How are USP Reference Standards tested for accuracy?

To confirm accuracy and reproducibility, USP Reference Standards are rigorously tested and evaluated by multiple independent laboratories including USP, commercial, regulatory, and academic labs.

Which is the primary reference standard of the USP?

USP’s Reference Standards are considered primary standards, except for certain biological USP Reference Standards with units of activity that are established against and traceable to the World Health Organization International Standards. USP does not develop secondary reference standards against its own primary reference standards.

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.

What is a reference standard 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. Which standard is…