What are reference standards?

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.

What is a biological reference standard?

Reference standards can be used to assign a potency value to a biologic drug. For example, a reference standard for trypsin crystallized may be used by a manufacturer to determine substrate quality. Some biological reference standards are used to test for the presence of specific impurities.

What is a reference standard sample?

A reference standard material is defined as highly purified compound that is well characterized by FDA (US Food and Drug Administration), and highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators by USP (US …

How do you qualify for reference standards?

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 are reference materials?

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

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%).

What is biological reference interval?

In health-related fields, a reference range or reference interval is the range or the interval of values that is deemed normal for a physiologic measurement in healthy persons (for example, the amount of creatinine in the blood, or the partial pressure of oxygen). This is the general reference range.

What are the five major types of reference sources?

The most familiar types are dictionaries, encyclopedias, almanacs, biographical sources, directories, atlases, and bibliographies.

What are examples 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 USP reference standard?

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 is RLD and RS in Orange Book?

The document describes what a reference listed drug (RLD) is, what an FDA reference standard (RS) is (a relatively new term with important distinctions from the RLD), and describes how the selection process should occur if the RLD is no longer marketed or removed from sale, as well as what to use for identification as …

What are three examples of general reference materials?

Items within the Reference Collection tend to include:

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

How are reference standards used in the biologic industry?

Reference standards can be utilized in different ways by manufacturers and can help supply solutions that support discovery, regulatory compliance, and process efficiency. Reference standards can be used to assign a potency value to a biologic drug.

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 publicly available, official documentary standards for pharmaceutical ingredients in the USP–NF that link directly with a primary reference…

How are reference standards used to test enzymes?

Reference standards like goserelin system suitability mixture, gonadorelin acetate-related compound A, and high-molecular weight insulin are specifically used to test for system suitability. For some enzymes, it is important to determine that the substrate being used is working as it should.

How are biotechnology standards used in fuel ethanol manufacturing?

Several properties of these materials like density, moisture content, ash content, carbohydrate content, and acid-insoluble residue content are studied. These biotechnology standards also help in the design and performance evaluation of fuel ethanol manufacturing facilities and biopharmaceutical facilities.