What are the requirements of a reference material?

REQUIREMENTS OF REFERENCE MATERIALS

• Homogeneity. Homogeneity assures that the analysis of all subsamples of the reference material taken for measurement will produce the same analytical result within the stated measurement uncertainty.
• Stability.
• Similarity to the real sample.
• Accuracy, uncertainty, and traceability.

What is the difference between reference standard and Reference Material?

The highest level of references is awarded to metrological standards that an authorized body must issue. Certified Reference Materials are considered to provide the highest level of accuracy, uncertainty and traceability to an SI unit of measurement.

What is a reference standard substance?

A reference-standard material is commonly defined as a “highly purified compound that is well characterized”, accordingly, the quality and purity of reference standards are crucial to determining scientifically valid results for many pharmaceutical analytical methods.

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 are the characteristics of reference sources?

Some of the characteristics of reference books are:

• They are intended primarily for occasional consultation.
• They are consulted for definite items of information.
• The information included in them is collected from a vast number of sources.
• It is a miscellany of information and facts.

What is reference standard in quality assurance?

The Reference Standards (RS) are used to achieve adequate quality control of substances for pharmaceutical use and pharmaceutical preparations. The reference standards are never intended for human therapeutic use, so patient safety is not directly impacted. The RS are elaborated according to suitable procedures.

What is the storage condition for reference standard?

The storage condition for an unopened USP Reference Standard can typically be found on the container label. Storage conditions are not provided in the Safety Data Sheets (SDSs). Instead, the SDS refers users to the USP RS label. Storage conditions are lot-specific and may change from one lot to another.

What is the use of reference standards?

Reference standards shall be used for analysis or qualification of working standards, as and when required. Impurity reference standards shall be used for analysis for various tests as per requirement. Handle the reference standards carefully. Ensure that the integrity is safeguarded and maintained throughout their period of use.

What are the market access and market acceptance requirements for products?

These requirements can vary by product and by individual organizations purchasing a product. For many companies, the individual client, importer, or trading partner will be the primary source of information on the market access and market acceptance requirements that should be followed for a particular product in a particular circumstance.

What is a primary reference standard?

Primary reference standards. 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.

What are the recommended storage conditions for reference standards?

Store the reference standards at the recommended or prescribed storage conditions. If storage conditions are not recommended by the pharmacopeia, manufacturer or supplier, store between 2°C to 8°C