Impurity testing is an important aspect of drug development and production to ensure the safety, quality, and efficacy of pharmaceutical products. Impurities in drugs can come from a variety of sources, including starting materials, manufacturing processes, degradation of the API or product, or interactions with packaging materials. These impurities may pose potential risks to patients, such as decreased efficacy, adverse reactions, or toxicity.
Protheragen-ING Lab offers reliable and comprehensive ICH pharmaceutical impurity testing services to identify and quantify the presence of a wide range of impurities in pharmaceutical products, including organic and inorganic impurities, residual solvents, degradation products, and potentially toxic substances. Our testing services follow the guidelines set by ICH, especially the ICH Q3 guidelines, to ensure accurate and reliable results.
Detectable drug impurities
We can provide you with the following types of drug impurity testing programs, including but not limited to：
Organic Impurity Test
Organic impurities can originate from starting materials, reagents, intermediates, or degradation products. We employ advanced analytical techniques, such as HPLC, GC, and MS, to detect and quantify organic impurities accurately.
Inorganic Impurity Test
Inorganic impurities include elements, compounds, or heavy metals that may be present as contaminants in pharmaceutical products. Our testing methods, such as atomic absorption spectroscopy (AAS) and inductively coupled plasma mass spectrometry (ICP-MS), enable precise identification and quantification of inorganic impurities.
Heavy Metal Test
Heavy metals, such as lead, arsenic, cadmium, and mercury, can be toxic even at low concentrations. Our testing service employs state-of-the-art techniques to detect and quantify heavy metal impurities, ensuring compliance with regulatory limits and patient safety.
Elemental Impurity Test
Elemental impurities encompass a broad range of elements that may be present in pharmaceutical products. Our testing procedures utilize techniques like ICP-MS, ICP atomic emission spectroscopy (ICP-AES), or ICP optical emission spectroscopy (ICP-OES) to accurately determine elemental impurity levels.
Residual Solvent Test
Residual solvents can be present in pharmaceutical products as a result of manufacturing processes. We utilize GC and other suitable analytical methods to identify and quantify residual solvents, ensuring compliance with established limits and guidelines.
Genotoxic Impurity Test
Genotoxic impurities possess the potential to damage genetic material and can have serious health implications. Our testing service employs validated methods, including specialized genotoxicity assays and analytical techniques, to detect and quantify genotoxic impurities accurately.
Pharmaceutical impurity analysis technology platform
- Chromatography Platform
- High-Performance Liquid Chromatography (HPLC) separates and quantifies impurities based on their chemical nature and interaction with the stationary and mobile phases of the chromatographic system.
- Gas Chromatography (GC) is mainly used for the analysis of volatile and semi-volatile impurities. It separates impurities based on their volatility and affinity for the stationary phase in the column.
- Thin Layer Chromatography (TLC) involves the separation of impurities on a stationary phase coated on a glass or plastic plate.
- Capillary Electrophoresis (CE): CE is a technique for separating charged impurities based on their electrophoretic mobility in an electric field. It is particularly useful for analyzing ionic impurities.
- Mass Spectrometry (MS): MS is often used in conjunction with chromatographic techniques for impurity identification. It provides structural information about an impurity based on its mass-to-charge ratio and fragmentation pattern.
- Fourier Transform Infrared Spectroscopy (FTIR): FTIR can be used to identify and characterize impurities based on infrared absorption spectra and can be used for qualitative and quantitative analysis.
- Nuclear Magnetic Resonance (NMR) Spectroscopy: NMR is used for structural elucidation and impurity identification, providing information about the connectivity and arrangement of atoms in the molecule.
- Thermal Analysis Platform: Thermogravimetric Analysis (TGA) and Differential Thermal Analysis (DTA) are used for moisture testing, water crystallization analysis, and impurity detection in pharmaceuticals.
Specialized analytical and identification knowledge
Protheragen-ING Lab provides pharmaceutical impurity testing for new APIs (ICH Q3A(R2)) and new drug products (ICH Q3B(R2)) and can support your product development throughout the lifecycle of your drug product. We have GLP-compliant laboratories, cutting-edge analytical technologies, and experienced scientists. Our scientists are experts in developing methods and validating suitable analytical techniques, frequently overcoming obstacles like challenging matrices and low detection levels.
All dosage forms, product classifications, and drug delivery technologies - including the creation of inhaled drug products - are covered by our testing capabilities. The knowledge we obtain from trustworthy analytical investigations can help your production impurity monitoring, expedite your medication development programs, and support your corrective and preventive action plans.
Contact us today to learn more about our ICH pharmaceutical impurity testing services and how we can assist you in navigating the complex landscape of drug development.