Elemental impurity analysis is a crucial aspect of drug development and manufacturing processes. It involves the identification and quantification of trace elements in pharmaceutical products that could potentially lead to harmful effects on patients. The presence of elemental impurities in drugs can arise from various sources such as raw materials, processing equipment, and packaging materials. Therefore, it is essential to have a robust elemental impurity analysis platform in place to ensure the safety and efficacy of pharmaceutical products. Our company has established a specialized elemental impurity analysis platform that provides comprehensive services for in the field of biopharmaceuticals. Our expert team utilizes state-of-the-art technology and analytical techniques to accurately assess elemental impurities in drug substances, ensuring compliance with regulatory requirements and safety standards.
Our Elemental Impurity Analysis Platform
Our elemental impurity analysis platform offers a comprehensive solution for pharmaceutical companies seeking reliable and robust elemental impurity testing services. This platform has the ability to provide method development and validation, as well as testing services for a wide variety of elemental impurities in drug manufacturing. Classifying drug elemental impurities according to ICH Q3D, elements that can be analyzed by our platform include the following three categories.
1Class 1 (High Toxicity)
This category includes elements such as arsenic (As), cadmium (Cd), mercury (Hg), and lead (Pb) which are known for their established toxicity and limited use in drug manufacturing. Due to the severe health risks associated with these elements, they require evaluation from all potential sources for all administration routes.
2Class 2 (Toxicity Varies by Route)
- Class 2a: This category includes elements like cobalt (Co), nickel (Ni), and vanadium (V). They require evaluation from all potential sources for all administration routes due to their varying toxicity levels.
- Class 2b: This category includes elements such as silver (Ag), gold (Au), iridium (Ir), osmium (Os), palladium (Pd), platinum (Pt), rhodium (Rh), ruthenium (Ru), selenium (Se), and thallium (Tl). Evaluation is necessary for these elements only if they are intentionally added to the drug product.
3Class 3 (Low Toxicity)
This category comprises elements with lower toxicity levels such as barium (Ba), chromium (Cr), copper (Cu), lithium (Li), molybdenum (Mo), antimony (Sb), and tin (Sn). Evaluation for these elements is required primarily for inhaled and parenteral administration routes.
Instruments and Equipment
Our elemental impurity analysis platform is is equipped with advanced instruments and equipment. These include:
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
- Atomic Absorption Spectroscopy (AAS)
- X-ray Fluorescence (XRF) Spectrometers
- Microwave Digester
- Graphite Digester
Moreover, they are equipped with sophisticated software for data analysis and interpretation, ensuring reliable results in compliance with regulatory standards.
Process at Our Platform
At our laboratory, we follow a systematic process for drug elemental impurity analysis to ensure the safety and quality of pharmaceutical products.
- Sample Preparation: We prepare the pharmaceutical sample for analysis by proper extraction and digestion procedures.
- Instrumental Analysis: We use suitable instruments such as ICP-MS and AAS to measure the elemental impurities present in the sample based on appropriate analytical methods.
- Data Interpretation: The data obtained is then analyzed and interpreted by our team of experts.
- Reporting: We provide a comprehensive report detailing the results of the analysis and any recommendations for corrective actions if necessary. For method development and validation, this report will detail the methodology, results, and conclusions of the analysis, as well as provide any necessary documentation and data to support the findings.
Drug elemental impurity analysis is a critical aspect of pharmaceutical development and manufacturing processes. By having a robust elemental impurity analysis platform in place and following regulatory guidelines such as ICH Q3D, pharmaceutical companies can ensure the safety and quality of their products. With advanced instruments and equipment, a systematic analysis process, and experienced staff, our laboratory offers a reliable solution for drug elemental impurity analysis, providing accurate and timely results for our clients. Contact us today to learn more about how our platform and services can benefit your projects.
Related Services
It should be noted that our service is only used for research, not for clinical use.
