H&M is happy to announce an expanded new testing arrangement to further assist our customers in meeting the recently revised testing guidelines for USP-NF General Chapter <901>, Detection of Asbestos in Pharmaceutical Talc. While H&M has always provided service for the X-ray diffraction (XRD) portion of this testing, we have now partnered with a second trusted laboratory for the polarized light microscopy (PLM) portion of the testing to ensure all parts of USP <901> for talc can be expertly addressed.
This comprehensive service helps pharmaceutical and cosmetics manufacturers confirm that their talc is below the USP defined limit for asbestos, a known carcinogen that can occur naturally in talc.
H&M evaluates pharmaceutical talc samples for the presence of asbestos by collecting the x-ray diffraction pattern from the submitted talc samples using scan parameters designed and verified to provide the needed sensitivity to detect asbestos in talc. Our partner lab, Particle Technology Labs, investigates the samples using polarized light microscopy (PLM), to confirm or rule out the presence of asbestos fibers below the provided guidelines, distinguishing true amphibole and chrysotile asbestos from look-alike particles that can otherwise be mistaken for contamination. As intended with the move to require both methods for pharmaceutical talc, together the methods support each other, helping reduce false positives and giving manufacturers more confidence in results.
“Partnering with PTL for this testing enables us to provide expert analyses on both testing fronts in our well-established fields of expertise while still offering the complete testing needed for this USP monograph. We can better provide pharma and cosmetics companies quality, comprehensive testing in this arrangement,” said Dr. Steven Mercurio, VP & Quality Manager at H&M Analytical Services.
Please contact H&M for more information on this testing by visiting our website or by emailing mail@h-and-m-analytical.com.
H&M is FDA registered and cGMP compliant.