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With a steadfast commitment to accuracy, reliability, and compliance, we empower pharmaceutical companies to focus on their core mission of advancing medical breakthroughs while leaving the intricate task of chemical assays and content determination in expert hands.
We use up-to-date methods and equipment to ensure accurate results.
Our team of dedicated scientists and technicians guarantee fast turnaround times without sacrificing accuracy. We provide accurate results so you can make timely decisions and move forward with confidence.
We ensure secure testing processes with strict protocols that guarantee confidentiality. All data is always kept secure, respecting the highest data integrity standards, ensuring your peace of mind when working with us.
Our range of tests covers a wide array of compounds and substances. Whether you require quantification, content determination, or identification of compounds, we have the expertise and technology to meet your specific needs.
We use various techniques and technologies including, High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ion Chromatography (IC), Ultraviolet-visible (UV-Visible) spectroscopy, Atomic Absorption Spectroscopy (AAS), Inductively Coupled Plasma (ICP-MS), mass spectrometry (LC/MS and GC/MS), among others.
Assay testing is performed to accurately quantify the concentration of a specific compound in a sample. It is crucial for quality control, potency assessment, and ensuring regulatory compliance.
Our content determination tests utilize techniques such as HPLC, GC, IC, UV-Visible spectroscopy, AAS, ICP-MS, LC/MS, and GC/MS to assess the content of compounds in samples accurately.
These tests are used in a variety of fields, including chemical screening, environmental testing, drug discovery, and more.
High Performance Liquid Chromatography (HPLC) is a type of chromatography used to separate and quantify compounds in a sample. It is used for the analysis of mixtures of compounds, with the goal of identifying and quantifying each component. HPLC utilizes a liquid mobile phase and a stationary phase, typically composed of silica particles bounded with organic chains, to separate compounds based on their differences in polarity.
Gas Chromatography (GC) is a form of chromatography used to separate and analyze compounds that can be vaporized without decomposition. In the pharmaceutical industry, GC is commonly used to determine the content of residual solvents and other volatile impurities in a mixture.
The use of assays and content determination by Ion Chromatography (IC) is important in ensuring that the quality of products produced is up to standard. IC is commonly used to measure the concentration of various components, such as anions and cations, in a product as well as its purity. This helps to ensure that the product meets the required specifications and is safe for use.
Ultraviolet and visible spectroscopy (UV-Visible) is used to obtain the absorbance spectra of a compound in solution. What is being observed spectroscopically is the absorbance of light energy or electromagnetic radiation, which excites electrons from the ground state to the first singlet excited state of the compound or material. The wavelength associated to this transition is typical of the molecular structure of the compound itself, making UV-Visible spectroscopy to be widely used alone or coupled with HPLC in the pharmaceutical industry.
Atomic absorption spectroscopy (AAS) is a commonly used method for the determination of elements in a sample. AAS works by measuring the amount of light absorbed by a sample at certain wavelengths; this is then used to calculate the concentration of the element in the sample. AAS is a robust and rapid technique that can be used to determine the content of various elements in pharmaceuticals either if they are intentionally added in the product formulation or found as elemental impurities.
The use of ICP-MS for assays and content determination is a common application in analytical chemistry. ICP-MS (Inductively Coupled Plasma coupled with Mass Spectrometry) is a multi-elemental analytical technique that involves the use of a high temperature plasma to ionize and excite sample molecules, which are then separated by mass in the mass spectrometer. This technique is used for accurate quantification and identification of elements present a trace level in a sample, making it an ideal tool for determination of elemental impurities.
Gas chromatography coupled with mass spectrometry (GC/MS) is an analytical method that combines the features of gas-chromatography and mass spectrometry to identify different substances within a test sample. This technique can rely on the robustness of the GC instrumentation and the sensitivity of MS to allow trace analysis of volatile impurities contained in pharmaceuticals.
Identification tests involve the use of various techniques such as spectroscopy, chromatography, and mass spectrometry to compare the properties of unknown substances with known reference materials, enabling accurate identification.
Yes, our advanced techniques, including ICP-MS, GC/MS and LC/MS enable us to accurately quantify trace elements in samples, even at sub-ppm level.
The turnaround time for assay, content, and identification tests depends on the specific tests required and the complexity of the samples. However, we strive to provide results within a reasonable timeframe without compromising accuracy.
Contact us to discuss your assay, content, and identification testing requirements and discover how our advanced techniques and expertise can provide reliable insights for your products and processes.Contact us