What is chemical reference substance?

Reference substance means any chemical substance or mixture, or analytical standard, or material other than a test substance, feed, or water, that is administered to or used in analyzing the test system in the course of a study for the purposes of establishing a basis for comparison with the test substance for known …

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 chemical reference standard?

A designated primary chemical reference substance is one that is widely acknowledged to have the appropriate qualities within a specified context, and whose assigned content when used as an assay standard is accepted without requiring comparison with another chemical substance.

What does EDQM stand for?

Quality of Medicines & HealthCare. Home. EDQM.

What is CRM in laboratory?

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. A certified reference material is a particular form of measurement standard.

What is CRM in ISO?

Certified Reference Materials (CRMs) are ‘controls’ or standards used to check the quality and traceability of products. 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 for calibration.

What is USP pharmaceutical grade?

USP-designated ingredients meet or exceed standards of purity set by the United States Pharmacopeia making them the highest quality grade. Only prescription drugs are required to meet USP standards. However, all active ingredients in Vivant products (and many of the inactive ingredients as well) are USP grade.

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.

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 Head space gas chromatography (HSGC-FID)

What is difference between EMA and EDQM?

The European Medicines Agency (EMA) works with the European Directorate for the Quality of Medicines and HealthCare (EDQM), a directorate of the Council of Europe. The EDQM traces its origins and statutes to a European treaty promoting the elaboration of a common pharmacopoeia in Europe.

What is CEP in pharma?

An API’s (active pharmaceutical ingredient) Certificate of Suitability (CEP) proves that its quality complies with the quality described in the relevant monograph of the European Pharmacopoeia; it therefore creates a direct link to the Ph.

What are the types of reference materials?

Reference Materials

• Dictionaries (both language and topical)
• Encyclopedias.
• Bibliographies (lists of resources on a specific topic)
• Research handbooks and guides.
• Catalogs.
• Atlases and maps.
• Directories.

What is reference standard in nabl?

Reference material characterized by a metrological valid procedure for one or more specified properties, accompanied by a certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability.

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 does 3 USP mean?

Look in your medicine cabinet, chances are you have a popular first aid antiseptic with a label that reads “Hydrogen Peroxide Topical Solution 3% USP” or something similar. Those 3 letters on the label means this product was made to USP standards.

What are reference standards in pharma?

What are reference materials?

Reference materials are various sources that provide background information or quick facts on any given topic.

What is EDQM certificate of suitability?

The Certification of Suitability (CEP) is a certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with that of the rules laid down in the monograph of the European Pharmacopoeia (EP).

What is a reference substance used for?

Reference substances (primary reference substances or secondary reference substances ( 8 )) are used for the testing of a sample. Note: Pharmacopoeial reference substances should be employed when available and appropriate for the analysis.

What is the best way to import Reference substances into IUCLID?

For example, the reference substances should be saved as .i6z files so they can be imported in IUCLID 6.

How do I get an up-to-date list of reference substances?

ECHA has started a project to make an up-to-date list of reference substances available using web services from ECHA’s dissemination database. Tips for the search and download: The wild card character % in a search criterion represents one or more characters.