How Analytical Methods In Research Are Changing As We Know It

Written by admin on. Posted in Analytical method validation guidelines, Electron microscopy sciences, Particle size distribution curve

Analytical method validation guidelines

Analytical methods in research are one of the most important parts of the process. If the end result is the roof of a house, then analytical method validation guidelines are the foundation that makes sure it doesn’t crumble. Nowhere is this more clear than the rules and regulations undercutting the drug industry, one of the most massive sectors of medicine in the West and one that relies on the constant analysis, upkeep and improvement of scientists, testers and analysts alike. Should you be considering a career in the pharmaceutical drug industry or simply want to know more about the process that goes behind a bottle of pills, look below to learn a little more.

Drug Industry

The United States is home to one of the most massive pharmaceutical drug industries in the world. Hundreds of millions of people regularly rely on the products created in laboratories, from basic pain medication to life-saving supplements for rare diseases. The necessities of laser diffraction and distribution of particle sizes is to create the safest and most reliable end result possible for the consumer, a task that has slowly but surely been made easier with the advent of more accurate technology.

Laser Diffraction

Ongoing advancements in technology has made it easier than ever to create accurate doses for common and rare medications. Laser diffraction has become one of the most commonly used particle sizing methods, particularly for particles in the range of 0.5 to 1000 microns. This is done by using a beam of light (or a laser) to scatter a group of particles, the angle at which the light works being inversely proportional to the particle size — this means that the smaller the particle size, the larger the angle needed to scatter the light.

Particle Sizes

Next up is the particle size analysis principle. One of the most influential properties of particulate materials is that of particle size, summing up the quality and performance. This goes for anything from powers to suspensions to emulsions — powder (or droplets) in the range of 2-5um will erosolize better and penetrate far deeper than larger sizes. This translates to how well the final product will dissolve when swallowed, contributing to its faster and more reliable process.

Common Errors

Reducing the margin for error is one of the most common concerns for nanotechnology laboratories across the country. Research has shown that inadequate dispersion is the greatest source of measurement error for particles below 20um — this has lead many to create more strict guidelines to ensure that even the most minor misstep is circumvented. Particle size analysis by either sieving or laser diffraction methods will usually include the following steps. The first is sampling of bulk powders, the second is sub-sampling of bulk samples for a specific specimen, the third is specimen preparation (or dispersion), the fourth is instrument set-up and verification and the fifth is taking measurements. The last few steps record data for future analysis.

Analytical Methods In Research

Electron microscopy sciences are going to continue to improve as the years go on. Analytical methods in research are becoming increasingly more accurate as technology improves, with higher standards being implemented no matter the product to maintain the most consistent results year-round. Even standard laser diffraction equipment can be used for particles that range from 400 nm up to just a few millimeters. Over the last twenty years laser diffraction has replaced traditional methods of particle sizing, including sieving and sedimentation, to make way for the future. With particle size distribution testing on our side, there’s little we can’t do.

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