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In pharmaceutical testing, the development and validation of analytical methods are absolute musts when it comes to reliable quality control. Natoli Scientific is at the forefront of offering comprehensive analytical method development and validation services designed to ensure the integrity of your company’s drug formulations. Our expert team develops robust methods tailored for each unique compound, with an approach that emphasizes precision, accuracy, sustainability, and compliance with regulatory standards such as the FDA and ICH guidelines. These methods are meticulously validated to confirm their reliability across a range of analytical parameters including specificity, sensitivity, linearity, and reproducibility.

This validation process is critical for verifying that our methods produce consistent, trustworthy results throughout the product’s lifecycle, thus fostering confidence in the safety and efficacy of pharmaceutical products.

HPLC Method for API Characterization and Quantification

High-Performance Liquid Chromatography (HPLC) stands as a cornerstone in Natoli Scientific’s suite of analytical services, particularly for the characterization and quantification of active pharmaceutical ingredients (API). The power of HPLC lies in its unparalleled precision and versatility, enabling our scientists to distinguish and measure the individual components of complex pharmaceutical formulations.

Tailored HPLC methods are developed for each specific API, focusing on achieving accurate separation, detection, and quantification. By adhering to stringent validation protocols, we ensure that our HPLC methods are reliable and repeatable, providing a solid foundation for the assessment of dosage forms in both the development stage and final product quality control.

Through the precise data gleaned from HPLC analysis, Natoli Scientific assists in confirming the purity and concentration of APIs, which is imperative for forecasting the drug’s therapeutic impact and ensuring regulatory compliance.

Developing Discriminatory Dissolution Media

At Natoli Scientific, we understand that reliable drug release data is critical for the development of successful pharmaceutical products. It’s here where developing discriminatory dissolution media becomes crucial. Our scientists specialize in formulating dissolution media with the ability to sensitively differentiate the release profiles of various drug formulations under biorelevant conditions. This service is particularly advantageous when evaluating the impact of formulation changes, such as different excipients or manufacturing processes, on the drug release rate.

The selection and optimization of dissolution media by our experts are tailored to the physicochemical properties of the APIs and the dosage form. Through our rigorous development process, we design media that challenge the drug product in a controlled way, ensuring that our clients’ products meet stringent regulatory standards and perform as intended in the patient’s body.

Dissolution Testing

In conclusion, the development and validation of analytical methods are essential pillars of reliable quality control in the pharmaceutical industry. At Natoli Scientific, we are committed to providing comprehensive services that ensure the integrity of your company’s formulations. Through our expert team’s meticulous approach, we develop robust methods tailored to each compound, emphasizing precision, accuracy, sustainability, and regulatory compliance. The validation process confirms the reliability of these methods across various analytical parameters, instilling confidence in the safety and efficacy of pharmaceutical products throughout their lifecycle. Our utilization of High-Performance Liquid Chromatography (HPLC) as a cornerstone of our analytical services enables us to accurately characterize and quantify APIs, ensuring regulatory compliance and facilitating the assessment of dosage forms. Additionally, our expertise in developing discriminatory dissolution media allows us to sensitively differentiate drug release profiles, aiding in the evaluation of formulation changes and meeting stringent regulatory standards. By partnering with Natoli Scientific, you can be assured of reliable, precise, and compliant analytical method development and validation services that contribute to the success of your pharmaceutical products. Contact the Team at Natoli Scientific

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Call us +1 636-926-8900