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. Types of Analytical Standards
Analytic standards are applied differently for different types of analysis. Typical ones are:
Active Pharmaceutical Ingredients (APIs): Measures of identity, purity, and concentration of pharmaceutical ingredients.
Impurity Standards: These are for measuring and monitoring impurities in pharmaceutical products so they conform to the safety and regulatory standards. They are necessary for stability testing and safety tests.
Excipient Standards: Used for the control of impurities in pharmaceutical formulations.
Water Quality Standards: Analytical standards for testing water samples for contaminants such as heavy metals, pH, turbidity and microbe count.
Air Quality Standards: These are used to measure air pollutants, such as NOx, SOx, ozone and particulate matter.
Soil and Sediment Standards: Values that measure the contaminants or toxins in soil and sediment used in environmental cleanups.
2.3 Chemical Standards
Solvents and Reagents: Analytical standards are used to validate the purity and identity of solvents and reagents for laboratory tests.
Metal Standards: Calibrated in atomic absorption spectroscopy (AAS), inductively coupled plasma (ICP) and other methods for trace metal analysis.
2.4 Biological Standards
Microbial Standards: Bacterial strains and other microorganisms that can be tested for disinfectants, sterilisation or antimicrobials.
Biological Activity Standards: These measures of compounds biological activity like enzyme activity or hormone activity.
3. Applications of Analytical Standards
Analytical norms are a part of all sorts of research, development and manufacturing activities. Here are some key applications:
3.1 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.
3.2 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.
3.3 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.
3.4 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.
3.5 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.
4. Choosing the Right Analytical Standard
When choosing an analytical standard, there are several considerations to make sure it is suitable for the analysis:
Purity and Traceability: The standard must be able to be purified and compared to a reference (pre-standard, pharmacopoeial reference).
Stability: Standard analytical parameters need to be stable in storage and during analysis for good accuracy.
Concentration or Potency: The standard should be the same concentration/potency as the analytical requirements of the test (calibration or method validation).
Certification: Analytical standards should carry a certificate of analysis (CoA) that is inclusive of purity, composition and lot number so that the standard meets regulatory and quality standards.
5. Best Practices for Using Analytical Standards
To help analytical standards to be effective, here are some best practices:
Proper Storage: Analytical standards must be stored at the right temperatures, humidity levels so that they do not degrade. Some standards might need to be refrigerated or shielded from sunlight.
Accurate Preparation: When preparing standard solutions, be sure to dilute and mix well so as not to get mistaken on concentration.
Periodic Recalibration: Analytical instruments need to be checked periodically with new standards for the sake of consistency.
Documentation: ocument the standards employed in analysis (where they came from, lot number, purity and conditions in which they were stored and handled).
Cross-Validation: Cross-validate the result using different analyses/labs, if possible, to verify results.
Conclusion
Analytical standards are the gold standard to ensure that materials are accurately and consistently analysed in any industry. From drug development to environmental testing, these protocols guarantee reproducible analysis. Laboratory should use and choose them wisely, ensuring they are tested properly and are not breaching the regulation. With the rise of technologies, analytical standards will be even more important for scientific discovery and the safe and good quality of goods sold in the marketplace.
