USP 901 Detection of Asbestos in Pharmaceutical Talc

Asbestos is a naturally occurring mineral that has been used for decades in many industries around the world, mainly due to its strength and heat resistance. Detection of asbestos in pharmaceutical talc is of particular concern as it is used in a variety of products, such as cosmetics and pharmaceuticals.

The revised talc monograph USP 901 is targeted to become official on December 1, 2025, and references a new polarized light microscopy (PLM) method which concentrates PLM-sized asbestos particles, ultimately improving detectability. Additional testing procedures will require analysis and data interpretation via x-ray powder diffraction (XRD). Electron microscopy tests including transmission electron microscopy (TEM) and scanning electron microscopy (SEM) are also being investigated as part of a phase 2 revision.

McCrone Microscopes & Accessories can help with your USP 901 analytical equipment needs and offers the following microscopy products, milling sample preparation equipment, 21 CFR Part 11 software packages, and training:

• Nikon’s Eclipse polarizing light microscopes are renowned for their ability to produce brighter, clearer, and higher contrast images, and with the exclusive McCrone dispersion staining objective, you’ll see what you couldn’t see before.

• For nearly 50 years the McCrone XRD Mill has been the industry standard for milling samples for XRD analysis. The unique grinding action of the McCrone XRD Mill rapidly reduces troublesome 0.5mm particles to sub-micrometer sizes required for quantitative and qualitative analytical methods.

• PAX-it! Extended Security imaging and software package enables scientists to meet the stringent compliance requirements of 21 CFR Part 11 with ease and flexibility. This software module’s contained archival environment enables labs to satisfy 21 CFR Part 11 requirements by restricting file access and manipulation to the application itself. We’ll visit onsite, install everything while working with your IT department, and provide full IQOQOQ documentation.
• In addition to IQOQPQ services, McCrone also offers customized training onsite at your location. Please let us know how we can assist with your training needs.

Learn more about how the trusted advisors at McCrone Microscopes & Accessories can help with your USP 901 requirements by requesting an online or in-person demonstration.