ELEMENTAL IMPURITY ANALYSIS
What is Elemental Impurity Analysis?
Elemental impurity analysis is a critical process in ensuring the safety and efficacy of pharmaceutical products. Pharmaceutical quality control and commercial release depend primarily on elemental analysis and trace metals testing. Understanding the elemental composition of raw materials, APIs, excipients, and formulations can ensure product quality and purity. When the elemental composition is unknown, a well-designed strategy is essential to rationalize effort and expense. For patient safety, the heavy metals in pharmaceutical finished products and raw materials must not exceed the specified limit values and must be tested for that. Heavy metals can be introduced into the product by catalysts, synthesis reagents and even by the manufacturing process itself.
How is Elemental Impurity Analysis Done at VitelyBio?
At VitelyBio, we utilize state-of-the-art techniques and equipment to perform elemental impurity analysis. Our team is equipped with in-depth subject knowledge & technology to support your analytical testing and applies a customized strategic approach to sample preparation for difficult samples and a range of analytical technology, relevant to your needs. We offer method development and validation where required, pharmaceutical analysis or pharmaceutical impurity testing via validated analytical methods and acceptance criteria to support the intended use. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards. Our process includes:
Sample Preparation
Samples are meticulously prepared to ensure accurate and reliable results. This step involves digestion or dissolution of the sample in appropriate solvents.
Expertise and Instrumental Analysis
We employ advanced analytical instruments such as Inductively Coupled Plasma Mass Spectrometry (ICP-MS) capable of detecting and quantifying trace levels of elements with high precision.
Data Interpretation
Our team of experts interprets the data to identify and quantify the elemental impurities present in the sample. We ensure compliance with regulatory guidelines such as ICH Q3D and USP <232>/<233>.
Reporting
Our team of experts interprets the data to identify and quantify the elemental impurities present in the sample. We ensure compliance with regulatory guidelines such as ICH Q3D and USP <232>/<233>.
Why Choose VitelyBio?
Expertise and Experience
Our team of scientists brings years of experience and specialized knowledge in bioequivalence studies, ensuring that your projects are handled with the utmost expertise.
Advanced Technology
We employ cutting-edge technology and methodologies to deliver accurate and reproducible results, giving you confidence in your data.
Regulatory Compliance:
VitelyBio is committed to adhering to the highest regulatory standards, ensuring that your studies meet all necessary guidelines and requirements.
Customized Solutions
We understand that each project is unique. Our flexible approach allows us to tailor our services to meet your specific needs and objectives.
Timely Delivery:
We value your time and strive to provide timely and efficient services without compromising on quality.