Working Standards vs Reference Standards

1. WORKING STANDARDS VS REFERENCE STANDARDS ======================================================== The research and development outcomes in the pharmaceutical industry are largely influenced by the efficacy, quality, and safety of the substances used in the experiment/study. To ensure that they are reliable and precise, several components of analytical methods are used. Two of them include reference standards and working standards. Even though they seem similar and cater to similar purposes, both these standards have different attributes and roles. However, not many people know this and thus the blog. Let's get into the basic difference between the two. Reference Standards What are Reference Standards? Reference standards, highly categorized compounds acting as points of reference for analytical testing. These standards are often sourced from prominent organizations and suppliers like EP (European Pharmacopoeia), USP (United States Pharmacopeia), and other certified reference materials suppliers. All the reference standards undergo meticulous examination and certification to ensure they are reliable for further use. Characteristics •Reference standards often come with CoAs (Certificates of Analysis) indicating complete information about their potency, composition, and other important traits. •The purity of these standards generally exceeds 99.9%, minimizing the errors when used during analysis or experiments. theclinivex.com

2. •These standards stay stable in particular storage conditions and offer consistent results throughout. •These standards enjoy global recognition from international regulatory agencies. Use The most popular applications of reference standards include: •Method validation •Calibration of instruments •Quality control Working Standards What are Working Standards? Working standards, acquired from reference standards. It is primarily used for routine laboratory quality control tests and analysis. They are often prepared in laboratories and are checked against reference standards to understand their usage suitability and potency. Characteristics The purity of the working standard is usually above 95%. Working standards are obtained from calibrating or diluting reference standards. Working standards are cost-effective, making them ideal for routine analysis. Uses Some of the most common uses of working standards sourced from reliable lab equipment suppliers include: •Daily calibration •Routine quality check •Intermediate checks Reference Standards vs Working Standards Characterization Reference standards are characterized after undergoing extensive testing. They help in determining exact physical and chemical properties. On the contrary, working standards are obtained and validated in-house and might not need detailing similar to reference standards. theclinivex.com

3. Purity The purity of reference standards often exceeds 99%, whereas that of working standards exceeds 95% Source Reference standard, often sourced from recognized institutions like USP and EP. Additionally, sourced from reliable CRM suppliers. Working standards, usually obtained by calibrating or diluting reference standards. Use The primary uses of reference standards include: 1.Calibration of analytical instruments 2.Validation of analytical methods 3.Quality control testing The primary uses of working standards include: 1.Daily calibration of analytical instruments 2.Cost-effective alternative for frequent testing 3.Intermediate checks and in-process controls in manufacturing Calibration Reference standards do not undergo routine calibration. Purity is maintained due to limited use. To ensure the accuracy, working standards need to undergo regular calibration unlike the reference standards. In this case, the frequency depends on the stability and use of working standards. Importance Reference standards set standards for characterization and purity. Whereas, working standards used to ensure reliable and consistent results for routine analysis. Conclusion Reference standards and working standards are both important to the pharmaceutical industry. They offer reliability and accuracy for routine and specific analysis. However, the quality of the standards influences the efficacy and thus sources all the standards from a trusted analytical reference standards supplier. Source: https://clinivex.wordpress.com/2024/10/21/working-standards-vs- reference-standards/ theclinivex.com