Chemical
We have over 20 years of chemical testing and analysis experience, and we apply our Total Quality Assurance expertise to pharmaceutical and consumer products.
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:
- cGMP
- GLP
- EN
- BS
- ASTM
- DIN
- JIS
- AFNOR
- ASME
- ANST
Elemental Analysis
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.
Scientech is capable of assessing levels of elemental metals / elemental impurities in raw materials, in-process formulations and finished pharmaceutical and provides analytical services to support compliance with Quality Control requirements on label-claim or demonstrating control of trace-level elemental impurities as published in the European Pharmacopoeia (EP) chapters 5.20 and 2.4.20 and the United States Pharmacopoeia (USP) general chapters <232> and <233>.
Cleaning Validation Analysis
