What are USP reference standards?

What are USP reference standards?

A USP Reference Standard (also known as a physical standard) is a known quantity of a drug substance or ingredient, developed in alignment with the specifications outlined in the USP–NF.

What is an analytical reference 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 makes a good reference standard?

There are several factors critical to production of a high quality reference standard or spiking solution including raw material handling, characterization and potency; certification and qualification of solutions; and homogeneity and stability of the solution.

What is reference standard in HPLC?

HPLC standards are defined reference compounds or materials that test the quality, purity, and identity of a particular test sample by comparison. Ready-to-use HPLC standards can reduce cost, streamline production processes and ensure reproducibility in research and development.

What is difference between USP and NF?

USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Excipient monographs are in the NF. However, if an excipient is also used as a pharmaceutical active in an FDA-approved product released in the US, its monograph will appear in the USP section instead.

What is the latest edition of USP NF?

The current version, USP–NF 2021, Issue 1, will become official on May 1, 2021. An ISO certified Spanish translation (certified to ISO 17100:2015 ) of USP–NF compendial content is available as the Spanish USP–NF Online.

What is CRM in lab?

Certified Reference Materials (CRMs) are ‘controls’ or standards used to check the quality and metrological traceability of products, to validate analytical measurement methods, or for the calibration of instruments.

What standard is used in HPLC?

In general, there are 2 main groups of HPLC standards, Primary standards (a.k.a. certified reference materials) and Secondary standards (a.k.a. working standards). They are useful in identifying the unknown substance, quantifying the analytes or calibrating the accuracy and the precision of analytical measurement.

How are reference standards used?

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.

What kind of certification does Cerilliant have for reference materials?

Cerilliant is an ISO 17034 and ISO/IEC 17025 accredited and ISO 9001 certified manufacturer of certified reference standards and certified reference materials.

How many Cerilliant catalog products are there in the market?

We offer more than 2,800 catalog products including parents, metabolites, & stable-labeled internal standards for pharmaceutical, clinical research & clinical & forensic toxicology, natural products, and environmental industries. Cerilliant is accredited to ISO 17034 & ISO/IEC 17025 and & ISO 9001.

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.

Are there any Cerilliant certified opioid reference materials?

The Centers for Disease Control and Prevention (CDC) has contracted Cerilliant to manufacture and distribute an Opioid Certified Reference Material Kit (Opioid CRM Kit) and Opioid Polysubstance Mix Kit (OPM Kit).