Q

Pharmaceuticals

qlabs-stability-testing-for-pharmaceuticals

Stability Testing for Pharmaceuticals

Stability testing is utilized to determine if the quality of a drug substance or drug product is altered over time by various environmental factors, such as light, temperature, and humidity. A drug “substance,” often referred to as an Active Pharmaceutical Ingredient (API), is defined as the unformulated material that may subsequently be formulated with excipients

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qlabs-determining-antimicrobial-effectiveness

Determining Antimicrobial Effectiveness

An antimicrobial or preservative is defined as a chemical agent that will kill or inhibit the growth of microorganisms. Common antimicrobials utilized in drug, OTC, cosmetic, and personal care products include parabens, alcohols, and quaternary ammonium compounds.  Antimicrobial Effectiveness Testing (AET) also known as Preservative Efficacy Testing (PET) is microbial challenge methodology performed to assure

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qlabs-periodic-table-graphic

New USP Elemental Impurities Chapters Near Implementation

On January 1, 2018, USP/NF Chapter 231 on Heavy Metals will be shuttled and new chapters 232, 233 and 2232 on Elemental Impurities will be implemented. What does this mean? It means that the century-old qualitative colorimetric test for the presence of Heavy Metals has been replaced by considerably more sophisticated methods (ICP-OES and ICP-MS)

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Is it a Cosmetic or a Drug… or Both

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers,

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