During 2025 Scientech Labs added Mass Spectrometry and Microbiology Labs to expand our capabilities for product safety testing to include detection of biological contaminants and chemical impurities at sub-ppb levels.

Scientech utilizes a wide array of advanced analytical techniques, including GC-MS, LC-MS, LC-MS/MS and ICP-MS, operated by highly skilled scientists to deliver accurate, FDA cGMP-compliant and defensible data. The Mass Spectrometry technology platform allows Scientech to offer testing for Extractables and Leachables (E&L), Nitrosamines, Heavy Metals, Elemental Impurities, API Impurities, Residual Solvents, Pesticides, and much more.

Our state-of-the-art analytical capabilities and experienced scientific team are equipped to help you:

- Assess potential Leachables from container-closure systems, medical devices, and drug-delivery systems.

- Identify and quantify levels of carcinogenic Nitrosamine impurities.

- Meet regulatory expectations from the FDA, EMA, and other global agencies.

- Customize study designs based on your product type and risk level.

- Proactively identify and address potential safety concerns before product launch.

- Accelerate product timelines with confidence.

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Scientech Labs’ 2,000 ft2 expansion in 2025 also included Microbiology Lab space outfitted with BCL-2 biosafety hoods, laminar flow hoods, incubators, and all of the instrumentation to conduct state of the art microbiology safety testing for pharmaceutical, cosmetic, and OTC drug products. All equipment and instrumentation have been fully qualified, methods validated, and FDA cGMP-compliant.

Scientech can provide Microbial Limit Testing/Test Method Suitability including compendial USP <61>, <62>, Antimicrobial Preservative Effectiveness including USP <51>, PET, PCPC (formerly CTFA), Burkholderia cepacia testing (USP<60>), bioburden, water testing, environmental testing, LAL/endotoxin testing and much more.

Please reach out to us for a consultation and/or a quote to support your analytical testing service needs at info@scientech-labs.com. For more information go to www.scientech-labs.com.

Scientech Laboratories supports the Pharmaceutical, OTC drug, Cosmetics, Dietary Supplement, and Botanicals industries with FDA cGMP-compliant quality testing of finished products and raw materials, support for product development, process development, formulation, and stability studies.

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