The Right Method to Meet Your Needs
At Neopharm, we specialize in developing customized chemistry methods for the pharmaceutical and biopharmaceutical industries. Our team of expert scientists and state-of-the-art laboratory facilities allow us to create, refine, and authenticate analytical methods suited to your needs.
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We have services to speed up your product development.
We provide reliable GMP quality control testing and innovative R&D solutions to accelerate product development and improve people's lives.
Contact usWhether it's to verify the feasibility of a method, perform its optimisation or a complete method development, we have the expertise and technology to deliver accurate and reliable results. Methods can also be qualified, transferred, verified or fully validated to answers your needs for a wide range of analytical areas, including assay and related substances, dissolution, residual solvents, genotoxic impurities, excipients, and additives. Our specialists master multiple analytical techniques such as chromatographic analysis (HPLC, GC) and mass spectrometry.
THE NEOPHARM SOLUTION
Robust Method Development & Qualification
Our Method Development services enable you to establish reliable and robust analytical methods tailored to your unique requirements. By utilizing our expertise in chromatographic techniques (GC, HPLC, UPLC, IC, chiral) and in-depth knowledge of mass spectrometry (GC/MS, LC/MS, ICP-MS), we help you develop methods that deliver precise and accurate results, ensuring the quality and safety of your pharmaceutical products.
Method Feasibility and Optimization
Determining the feasibility of an analytical method and optimizing it for improved performance is essential for efficient and cost-effective analysis. Our scientists assess the suitability of methods for your specific matrix and sample type, providing recommendations for optimization to enhance sensitivity, selectivity, and efficiency, ultimately streamlining your analytical processes.
Method Transfer, Verification, and Validation
Transferring, verifying, and validating analytical methods or monographs from one laboratory to another is a critical step in maintaining consistency and ensuring regulatory compliance. Our experts have extensive experience in method transfer and validation, employing rigorous protocols to ensure method accuracy, precision, specificity, and robustness.
Assay and Related Substances Analysis
Accurate determination of assay and related substances is crucial for assessing the quality, potency, and purity of drug substances and drug products. Our expertise in various analytical techniques and regulatory requirements allows us to perform comprehensive analysis, delivering precise results that meet regulatory standards.
Dissolution Studies
We provide dissolution studies services to evaluate the drug products dissolution rate from solid dosage forms. We provide accurate and reliable dissolution data, enabling informed decision-making in formulation development and quality control.
Residual Solvents & Genotoxic Impurities
Our specialized testing services focus on identifying and quantifying potential residual solvents and genotoxic impurities that may be present in drug substances or products. Our rigorous approach to testing guarantees that your products meet stringent quality standards, mitigating any potential health hazards.
Excipients and Additives
Our characterization of excipients and additives uses analytical techniques such as HPLC, GC, LC/MS/MS, FTIR, UV-Visible, KF, and others to ensure quality and purity of these materials.
Neopharm Answers to Common Questions About Method Development and Validation Services in Chemistry
Method development ensures the availability of accurate and reliable analytical methods for assessing the quality, purity, and potency of pharmaceutical products. It enables efficient and effective analysis, supporting product development, manufacturing, and regulatory compliance.
Method validation is the process of demonstrating that an analytical method is suitable for its intended purpose and provides reliable and accurate results. It is essential for establishing the performance characteristics, such as specificity, accuracy, precision, and robustness, ensuring the method's suitability for routine use.
Yes, our Method Feasibility and Optimization services are designed to assess the performance of existing methods and identify opportunities for improvement. We optimize methods to enhance sensitivity, selectivity, and efficiency, allowing for more accurate and cost-effective analysis.
Method transfer and verification involve a systematic approach to ensure the consistency and reliability of results across different laboratories. We employ rigorous protocols, including establishing equivalence between instruments, comparing results, and assessing method performance parameters, to ensure successful transfer and verification.
Method development ensures the availability of accurate and reliable analytical methods for assessing the quality, purity, and potency of pharmaceutical products. It enables efficient and effective analysis, supporting product development, manufacturing, and regulatory compliance.
Method validation is the process of demonstrating that an analytical method is suitable for its intended purpose and provides reliable and accurate results. It is essential for establishing the performance characteristics, such as specificity, accuracy, precision, and robustness, ensuring the method's suitability for routine use.
Yes, our Method Feasibility and Optimization services are designed to assess the performance of existing methods and identify opportunities for improvement. We optimize methods to enhance sensitivity, selectivity, and efficiency, allowing for more accurate and cost-effective analysis.
Method transfer and verification involve a systematic approach to ensure the consistency and reliability of results across different laboratories. We employ rigorous protocols, including establishing equivalence between instruments, comparing results, and assessing method performance parameters, to ensure successful transfer and verification.
Partner with Neopharm and harness the power of precision through our Method Development and Validation Services in Chemistry. Contact us today to discuss your analytical requirements and benefit from our comprehensive range of services tailored to your specific needs.
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