Pharmaceutical impurity reference standards are calibration materials used to measure and identify the presence of impurities in pharmaceutical products. They play an important role in ensuring the safety and quality of these products. There are various pharmaceutical impurity reference standards, each with its specific purpose.
One common type of impurity standard is a drug substance reference standard. This type of standard is used to measure the purity of drug substances. In addition, it can help ensure that the drug substance meets certain quality criteria and that any impurities present are within specified limits.
Another common type of impurity reference standard is a drug product reference standard. This type is used to measure the purity of drug products. It can help ensure that the product meets certain quality criteria and that any impurities present are within specified limits.
The standards are also used to identify impurities in pharmaceutical products. This reference standard typically consists of a mixture of different drug substances and/or drug products. By identifying the impurities present in this mixture, analysts can determine the identity and relative proportions of the impurities in the analyzed product.
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