Raw Materials
Quality Chemical Laboratories provides a wide range of chemistry expertise and instrumentation to analyze all types of raw materials, including compendial testing, development, qualification, and validation of new methods. QCL offers routine 10-15 business day turnaround-time for compendial monograph testing in an FDA regulated, cGMP environment. Rush turnaround is available upon request and with prior approval. QCL has a dedicated group of experienced chemists, and our sample management system assures sample traceability throughout lifecycle of testing and GMP review.
**NEW TESTING CAPABILITY UPDATE**
USP Talc Asbestos Testing
Detection of Asbestos in Pharmaceutical Talc
Quality Chemical Laboratories (QCL) offers analytical testing for the detection of asbestos in pharmaceutical-grade talc in accordance with the revised USP Talc monograph and USP General Chapter <901> – Detection of Asbestos in Pharmaceutical Talc.
The updated USP requirements incorporate a combination of X-Ray Powder Diffraction (XRPD) and Polarized Light Microscopy (PLM) to evaluate pharmaceutical talc for the presence of asbestos. QCL provides both analytical techniques as part of a comprehensive testing approach designed to support compliance with current USP requirements.
Testing Capabilities
- X-Ray Powder Diffraction (XRPD) – Evaluation for the presence of amphibole and/or serpentine minerals in talc.
- Polarized Light Microscopy (PLM) – Microscopic examination and characterization of particles to determine whether asbestos is present.
- USP <901> Testing – Testing performed in accordance with the USP General Chapter for Detection of Asbestos in Pharmaceutical Talc.
- Pharmaceutical Talc Testing – Support for raw material qualification, supplier assessment, release testing, and ongoing quality control.
Why Asbestos Testing Matters
The revised USP Talc monograph reflects the pharmaceutical industry’s need for a more robust approach to asbestos detection in talc. Talc containing detectable asbestos is not considered pharmaceutical grade under the USP definition.
QCL’s combination of XRPD and PLM capabilities provides pharmaceutical manufacturers and raw material suppliers with access to the analytical testing necessary to evaluate talc in accordance with the updated compendial requirements.
Need USP Talc Asbestos Testing?
Contact QCL to discuss your testing requirements, sample quantities, turnaround time, and project-specific needs.
Techniques, Tests and Instrumentation
WET CHEMISTRY TESTING:
TITRATIONS – POTENTIOMETRIC AND COLORIMETRIC
LIQUID CHROMATOGRAPHY- HPLC, ION CHROMOTOGRAPHY, UPLC, TLC
DETECTORS: UV, CAD, RI, PDA, ELSD, FL, EC, MS, AND CONDUCTIVITY
GAS CHROMATOGRAPHY – HEADSPACE, DIRECT INJECT, <467>RESIDUAL SOLVENTS
DECTECTORS: TCD, FID
KARL FISCHER AND COULOMETRIC KARL FISCHER ANALYSIS INCLUDING COULOMETRIC KARL FISCHER OVEN
VISCOSITY
PHYSICAL TESTING:
- DIFFERENTIAL SCANNING CALORIMETRY
- THERMO GRAVIMETRIC ANALYSIS
- PARTICLE SIZE ANALYSIS – MALVERN 3000 AND SIEVE
- SPECIFIC SURFACE AREA
- X-RAY POWDER DIFFRACTION
- FOURIER TRANSFORM INFRARED SPECTROSCOPY
- ULTRAVIOLET-VISIBLE SPECTROSCOPY
- METALS ANALYSIS – ICP-OES, ICP-MS, ATOMIC ABSORPTION, AND GRAPHITE FURNACE
- TOTAL ORGANIC CARBON
- NUCLEAR MAGNETIC RESONANCE (NMR)
