Raw Materials
**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.
All documentation is professionally detailed and completely GMP reviewed at test completion prior to issuance of the COA. Due to the stringent checks and balances between the laboratory and the Quality Assurance group, all final results are accurate and reliable.
Industries We Serve
Our raw material testing laboratory in Wilmington, NC serves a broad range of regulated and non-regulated industries. Pharmaceutical manufacturers and CDMOs rely on us for compendial monograph testing, identity verification, purity analysis, and supplier qualification support. Nutraceutical and dietary supplement companies use our laboratory for raw material identity testing, potency verification, and certificate of analysis review. Cosmetic and personal care companies submit raw materials for identity, purity, and microbiological testing in support of product development and quality control. Food and beverage producers require raw material testing for ingredient verification, contaminant analysis, and supplier qualification. Medical device manufacturers submit materials for characterization and biocompatibility support testing. Whatever your industry, our team can discuss your specific raw material testing requirements and develop a testing plan that meets your regulatory and quality objectives.
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)
Frequently Asked Questions
Quality Chemical Laboratories provides a comprehensive range of raw material testing services including compendial monograph testing, identity testing, purity and potency analysis, method development and validation, physical characterization, and supplier qualification support. Specific capabilities include wet chemistry, titrations, liquid chromatography (HPLC, UPLC, TLC), gas chromatography, Karl Fischer analysis, viscosity, differential scanning calorimetry, thermogravimetric analysis, particle size analysis, X-ray powder diffraction, FTIR spectroscopy, UV-Vis spectroscopy, metals analysis by ICP-OES and ICP-MS, total organic carbon, nuclear magnetic resonance (NMR), and USP Talc Asbestos Testing by XRPD and PLM. We also support new method development and validation for client-specific or proprietary methods.
We serve pharmaceutical manufacturers and CDMOs, nutraceutical and dietary supplement companies, cosmetic and personal care product companies, food and beverage producers, and medical device manufacturers. Our laboratory is FDA regulated and cGMP compliant and can accommodate testing requirements across a wide range of regulatory frameworks including USP, EP, and JP Pharmacopoeial standards.
Standard turnaround time for compendial monograph testing is 10 to 15 business days. Rush turnaround is available upon request and with prior approval. Turnaround times for method development, validation, and non-standard testing vary depending on the scope of work and are confirmed at the time of quote. Contact us at 910-796-3441 to discuss your timeline requirements.
Yes. Quality Chemical Laboratories is an FDA regulated, cGMP compliant laboratory. Our raw material testing follows USP, EP, and JP Pharmacopoeial methodologies. We can also develop and validate company-specific or product-specific methods to meet your quality and regulatory requirements. All documentation is GMP reviewed and a Certificate of Analysis (COA) is issued at test completion following stringent checks between the laboratory and the Quality Assurance group.
To submit samples, contact us to request a quote and discuss your testing requirements. Our team will confirm the appropriate sample quantities, packaging requirements, storage conditions, and documentation needed for your specific tests. Once your quote is approved, samples can be shipped to our Wilmington, NC laboratory or dropped off in person. Our sample management system ensures traceability throughout the full testing and GMP review lifecycle. Call us at 910-796-3441 or use the Submit a Sample link on this page to get started.
Quality Chemical Laboratories is located in Wilmington, NC. Our visitors address is 3220-A Corporate Drive, Wilmington, NC 28405. Our corporate address is 3400 Enterprise Drive, Wilmington, NC 28405. We serve pharmaceutical and regulated industry clients throughout North Carolina and nationwide. Call us at 910-796-3441 or visit QualityChemLabs.com for more information.
