Antibiotic Potency Testing: The Methods - Part 2

Using the Turbidimetric Method

In part one of this blog series, we discussed Antibiotic Potency Testing using the Diffusion (Cylinder-Plate) method.

Antibiotic potency assays using microbiological methods are required by both the European and United States Pharmacopoeia for some antibiotic products. Physicochemical methods, such as immunological assays and High-Performance Liquid Chromatography (HPLC) have become commonplace for determining the concentration of API and for the concomitant determination of Assay and impurities. However, microbiological assays provide a true measure of how effectively an antibiotic kills or inhibits a target microorganism at a specified concentration.

Topics: Blogs

White Paper: Abuse-Deterrent Studies for Controlled Drugs - A Changing Landscape

Governmental and regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and Department of Health and Human Services (HHS), have made significant investments towards the reduction of the misuse of prescription drugs.

Engineering abuse-deterrent properties into prescription forms of drugs with abuse potential has become a primary strategy for abuse prevention.

Topics: Abuse-Deterrence White Paper / eBook

Antibiotic Potency Testing: The Methods – Part 1

Using the Diffusion (Cylinder-Plate) Method 

Both the European Pharmacopoeia and the US Pharmacopeial Convention (USP) require testing of antibiotic potency using microbiological assays for some products. When the potency of an antibiotic is measured chemically, its concentration in solution is all that is determined. Conversely, a microbiological assay verifies the ability of the antibiotic to kill the target organisms, as well as the concentration at which the antibiotic will kill effectively.

A microbiological potency assay measures the effectiveness of an antibiotic by the degree of growth inhibition on susceptible strains of microorganisms at differing concentrations. One of the two methods defined in the pharmacopoeia to make this determination is the Diffusion (Cylinder-Plate) method.

Topics: Blogs


Name: Christopher Williams
Alcami Site: Wilmington, NC

How long have you been with Alcami?
I have been with Alcami for six years.

What is your role?
I am the Manager of a Method Development and Method Validation group, which is part of the Development Services team at our Wilmington, NC location.

What is the most rewarding part of your job?
Having the opportunity to learn and help others around me learn every day.

Topics: Blogs

Need to Know: Details About Alcami's New St. Louis, MO Facility

You've probably heard by now that our St. Louis, MO site is relocating. The current Alcami St. Louis facility for laboratory operations will be transitioning to a new building being constructed at the following location:

4260 Forest Park Avenue
Suite 201
St. Louis, MO 63108

Read on to see what we have planned for our new state-of-the-art facility!

Topics: News & Events Analytical Testing

Elemental Impurities: The Risk-Based Approach

The U.S. Pharmacopeia (USP) intends to remove the existing wet chemistry heavy metals methods outlined in USP General Chapter <231> by January 2018. Although the existing wet chemistry methods have been in effect for nearly 100 years, the methods are non-specific and frequently fail to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredients. The USP requires Plasma Spectrometry (ICP-MS or ICP-OES) as the technique to screen and/or accurately quantitate the presence of any elemental impurities of interest.  From a compliance perspective, the new guidance for elemental impurities (USP<232>and ICH Q3D) only applies to the drug product.  There are currently two strategies to meet the requirements for elemental impurities, with the first being a risk-based approach.

Topics: Regulatory Compliance Elemental Impurities