Valuable Insights for Risk Mitigation and Quality Control Strategies

Neopharm delivers impurity profiling and characterization with trace component isolation as low as 0.01% and batch scale chromatography for fast isolation from feedstock.

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At Neopharm, we specialize in elemental impurities studies, offering multiple approaches to analyze elements listed in USP <232> and beyond, tailored to various dosage forms. Our services include method development and validation according to USP <233> and ICH Q3D requirements. We provide both quantitative and limit test approaches to support your specific needs. With in-house screening methods, we offer risk assessment evaluations to ensure the safety and compliance of your products.


Our proprietary Neopharm’s Targeted Isolation™ has been a remarkably successful program supporting both drug substance and drug product development. Whether solving problems during clinical development, completing CMC filings, or improving GMP synthesis, our impurity isolation is a proven strategy for reducing development costs and time.

High Precision Measurements

The presence of elemental impurities in a product can have different levels of risk depending on the type of product and how it is used. To help you assess this risk, we use our own screening techniques to evaluate the potential impact of these impurities on your product. By identifying and quantifying these impurities, we can provide you with useful information for managing risks and maintaining quality control.

Highly Efficient Processes

We offer fast timelines, allowing you to get the results you need quickly and efficiently, without compromising on accuracy or quality.

Degradation Kinetics Analysis

Our advanced tools enable us to provide comprehensive degradation kinetics analysis so you can better understand formation, purge, and fate of your product.

Tailored Approaches for Different Dosage Forms

Different dosage forms may require specific approaches for elemental impurities analysis. We offer customized solutions for solid, liquid, and other dosage forms, considering the unique characteristics and requirements of each formulation. Our expertise allows us to adapt the analytical techniques and methodologies to provide accurate results for your specific dosage forms.

Risk Assessment and Screening Methods

Elemental impurities may pose varying levels of risk depending on the specific product and its intended use. Our in-house screening methods enable us to perform risk assessments and evaluate the potential impact of elemental impurities on your products. By identifying and quantifying impurities, we can provide valuable insights for risk mitigation and quality control strategies. 

Neopharm Answers to Common Questions About Extractables and Leachables Studies

We analyze elements listed in USP <232> as a standard, and we can go beyond that based on client request. Our analytical methods cover a wide range of elements, including heavy metals and other elemental impurities of concern. We tailor the analysis to the specific requirements of your product and can provide quantitative and limit test approaches as needed.

Yes, we have extensive experience in method development and validation for elemental impurities analysis following the guidelines of USP <233> and ICH Q3D. Our team of experts can design, optimize, and validate methods that meet the specific requirements of your products, ensuring accurate and reliable results.

We perform risk assessments by utilizing in-house screening methods and evaluating the potential impact of elemental impurities on your products. Our team assesses the levels of impurities, their toxicological profiles, and the intended use of the product to determine the associated risks. Based on the results, we provide recommendations for risk mitigation and quality control strategies.

Absolutely. We offer elemental impurities analysis for a wide range of dosage forms, including solid, liquid, and other formulations. Our tailored approaches take into account the unique characteristics and requirements of each dosage form, ensuring accurate and reliable results that support your product's safety and compliance.

For comprehensive elemental impurities studies that ensure safety, compliance, and peace of mind, contact Neopharm today. Our experienced team is ready to discuss your specific needs and provide tailored solutions for your elemental impurities assessment.

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