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Contact usEnhance your quality control processes with Neopharm's expertise in Related Substances and Impurities analysis. Our comprehensive analysis allows you to identify and quantify impurities, degradation products, and related substances in your pharmaceutical formulations. By implementing our testing services, you can strengthen your quality control measures, ensure regulatory compliance, and deliver safe and reliable pharmaceutical products.
Our expert team utilizes advanced analytical techniques and state-of-the-art instrumentation to uncover even the most subtle impurities, ensuring compliance with regulatory guidelines and maintaining the highest quality standards.
We use a range of advanced analytical techniques and technologies such as HPLC, GC, IC, UV/Visible, AAS, ICP-MS, LC-MS, GC-MS etc. to accurately identify and quantify the presence of impurities in your samples.
Our Related Substances and Impurities analysis services offer in-depth characterization and quantification, enabling you to understand the impact of these substances on product quality and safety. With our expertise, you can make informed decisions regarding raw materials, manufacturing processes, and quality control, ensuring the highest standards of pharmaceutical excellence.
We offer unrivaled customer service with a fast turnaround time for all our testing services – ensuring you’re able to meet your deadlines without compromising on quality.
Related substances are chemical entities closely related to the drug substance or active pharmaceutical ingredient (API) but are not the intended product. Foreign impurities, on the other hand, are unwanted substances that may arise during the synthesis manufacturing, or storage of the drug product, or may come from degradation of an excipient. Both related substances and foreign impurities need to be identified, characterized, and quantified to ensure product safety and compliance with regulatory standards.
Neopharm utilizes a combination of advanced analytical techniques, such as high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), and spectroscopic methods, to analyze related substances and foreign impurities. Our experienced team follows validated methods and employs stringent quality control measures to ensure precise and reliable results.
Absolutely. Neopharm has extensive experience in analyzing related substances and foreign impurities in a wide range of pharmaceutical formulations, including complex matrices. Whether you require analysis for small molecules, biologics, or combination products, our team has the expertise and resources to handle the complexity and provide accurate characterization and quantification of any type of impurities.
The timeframe for impurities analysis can vary based on factors such as the complexity of the sample, the number of substances to be analyzed, and specific testing requirements. During our initial consultations, we will discuss project timelines and provide you with realistic estimates to ensure effective planning and alignment with your objectives.
Choose Neopharm for precise and comprehensive Related Substances and Impurities analysis services that prioritize product safety, regulatory compliance, and pharmaceutical excellence. Contact us today to ensure the purity and integrity of your pharmaceutical products.
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