We partner with companies of all industries to ensure their chemical testing and analysis complies with regulatory and safety requirements. To better understand the quality and composition of chemical substances and materials used in products, and in manufacturing processes, chemical testing and analysis is imperative for regulatory compliance. With 40 years of experience, Scientech has expert industry knowledge in applying the most relevant methodology towards successful chemical testing. We use advanced analytical instrumentation and techniques to address your projects. We comply and perform testing protocols in accordance with the following standards in order to develop tailored analytical methods and performing method validation for your specific testing requirements.
Metal impurities are introduced into pharmaceutical products and dietary supplements from raw materials, catalysts, equipment, and the environment. Changing regulatory requirements now require manufacturers to determine elemental impurities in new and existing products. These analyses include metals analysis and the analyses of inorganic, aqueous, and non-aqueous materials.
Scientech utilizes the instrumental techniques of Inductively Coupled Plasma-Mass Spectrometry (ICPMS). ICP is a very high temperature excitation source that efficiently desolates, vaporizes, excites, and ionizes atoms. A mass spectrophotometer is utilized to separate and detect the ions (ICP-MS). The intensity of this emission or ions is indicative of the concentration of the element within the sample. The use of ICP will allow specific, multi-element determinations with sensitivities down to the part-per billion (ppb) levels.
Utilizing our expertise and sophisticated instruments we are able to detect contamination of equipment. A swift response could save our clients time, money, and scrutiny from regulatory agencies.
cGMP compliant
FDA registered
DEA licensed
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