Understanding the Applications of Reference Standards

Reference standards are required to assess the purity of chemicals in pharmaceuticals, and medical goods cannot be overstated.

Let’s get to the applications of reference standards without further ado. 

Identification

The material present in a substance or product is identified using reference standards. A batch of good quality material selected from the usual production process is satisfactory for use in identification tests (IR spectrophotometry or chromatographic techniques) if it has acceptable purity.

Instrument calibration

Calibration material can also be used as a reference standard. The scope of testing is similar to that of a reference standard used in assays in such circumstances.

Purity

Reference standards are used to determine the purity of a substance or product and identify and quantify contaminants. A chemical reference standard's characterization for use in determining a specific impurity is more detailed, especially when utilized in a limit test. 

When thin-layer chromatography (TLC) is used, an acceptable minimum purity is advised, usually at least 90 percent. On the other hand, when liquid chromatography (LC) or gas chromatography (GC) is used, a purer material may be required at least 95 percent.

Degradation products

The degradation products are identified and perhaps quantified using reference standards. You must procure these from the bets reference standards supplier in Canada. 

Assay

To determine potency, reference standards are essential. The scope of testing is substantially broader if the chemical reference standard is to be utilized in an assay. When using a nonspecific assay method, such as colorimetry or UV spectrophotometry, the relative reactivity or relative absorbance of the impurities must be verified. 

It is critical to assess the number of contaminants when using a selective assay method. In this instance, it is best to analyse the suggested reference standard using as many approaches as feasible, including absolute methods when possible.

In final words, reference standards are utilized for a variety of purposes. You must procure it from a reliable supplier. We at Clinivex provide qualitative, reliable, and consistent reference standards entitling us as the best pharmaceutical reference standards supplier.