A Guide to Using Analytical Standards
Analytical standards are fundamental to the pharmaceutical, chemical and environmental industries as they serve as the basis of precise and reproducible analysis. These standards make it possible for laboratory output to be repeatable, accurate, and comparable between labs and regions. They help ensure the safety, efficacy and quality of drugs, chemicals and environmental goods.
1. What Are Analytical Standards?
Analytical standards are reference chemicals or substances to calibrate instruments, validate processes and confirm the reproducibility of analytic measurements. They are typically purity, concentration or composition standards and give you a well-known reference point in which to analyse. They're critical to measuring the concentration of analyte in samples, to calibrating detection equipment, and to verifying the quality of analyses.
There are two kinds of analytical standards:
Primary Standards: These are ultra pure products whose amount is known. They calibrate analytical instruments or manufacture calibration solutions.
Secondary Standards: These are the drugs calibrated to the primary standards and are employed in everyday analyses.
2. Applications of Analytical Standards
Analytical norms are a part of all sorts of research, development and manufacturing activities. Here are some key applications:
2.1 Instrument Calibration
The analytical standards are the instruments calibrated in the lab to be exact and precise. In chromatography, for example, the calibration curve is built from standards of known concentration to determine the concentration of analyte in unknowns. Reference materials in spectroscopy are applied to verify the wavelength and intensity of light that is being scattered or absorbed by samples.
2.2 Method Validation
Analytical standards are needed to check the performance of the analytical method when the method is developed and validated. The test is carried out on the standard, measuring precision, accuracy, linearity, and specificity so that the procedure is conformant to the regulations.
2.3 Quality Control and Assurance
For manufacturing of drugs and chemicals, analytical standards are used in quality control to verify raw materials, intermediates and finished goods are of the specified standards. Everyday testing against standards ensures that products are stable, conform to regulations and safe for the end-user.
2.4 Regulatory Compliance
Authorities and international authorities (e.g., FDA, EMA, ICH, USP, EP) demand the application of analytical standards to make sure drugs, chemicals and environmental products meet the safety and quality standards. Analytical guidelines are adopted to create documents such as drug submissions, permits for environment and chemical safety reports.
2.5 Research and Development
Analytical criteria are fundamental in R&D of new drugs, chemicals, and materials. They are employed early in R&D to measure purity and composition of new molecules, consistency in formulation, and stability in storage and use.