Analytical Services

JSI Research Chemicals Inc offers a wide range of laboratory techniques and supports customers throughout the development and validation process. We offer a wide range of services, including method development, optimization, feasibility studies, qualification, validation, and verification suitable for different phases of product development.

Our organization has great expertise in method development and validation for organic impurities, particularly in the context of API and finished doses in the pharmaceutical industry. Here are some key highlights of our capabilities:

  1. Experience in Method Development: We have years of experience in developing methods for detecting organic impurities in various pharmaceutical components, including raw materials, intermediates, API, and finished doses. This expertise is crucial for ensuring the safety and quality of pharmaceutical products.
  2. Specialization in Genotoxins and Trace Level Impurities: We are expert in developing methods for genotoxins and trace-level impurities using High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS). Our ability to leverage these technologies enhances the accuracy and sensitivity of your testing methods.
  3. Efficient Method Validation: Our validation experts can validate methods efficiently, following regulatory guidelines such as ICH, FDA, and USP. This ensures that your methods meet the necessary standards for accuracy, precision, and reliability.
  4. Comprehensive Validation Documentation: We are committed to providing validation protocols, validation summaries, method transfer reports, and validation reports in a timely fashion.
  5. Cleaning Validation Expertise: Our organization is well-equipped to handle cleaning validation, which is crucial for ensuring that residue on surfaces, equipment, and containers do not contaminate pharmaceutical products. This includes the development and validation of methods for detecting residues in rinse and swab samples, even at trace levels.

Why JSI Research Chemicals for your analytical method development and validation?

Our organization provides comprehensive and efficient services for method development, and validation. 

We will provide you the best service that you need for your projects. We follow and we do:

  1. Collaborative Approach: We emphasize collaboration with clients, understanding their testing needs, and designing customized project approaches to achieve their specific goals. This approach helps in optimizing research budgets and ensures that methods are developed and validated to meet their intended use.
  2. Phase-Appropriate Method Validation: Our services include phase-appropriate method validation, which means adapting the validation process to the specific phase of product development. This flexibility ensures that methods are validated in a manner that aligns with regulatory requirements and the development stage.
  3. Full cGMP Compliance: All our work is conducted under current Good Manufacturing Practices (cGMP) compliance. This ensures that the testing and validation processes meet the stringent quality and regulatory standards required in the pharmaceutical and related industries.
  4. Experienced Staff: Our organization boasts a highly experienced team, which is essential for the successful execution of validation, qualification, verification, and transfer protocols. Their expertise ensures the reliability and accuracy of the testing methods.
  5. Seamless Method Transfer: Collaboration between our Method Development and Validation team and receiving labs ensures a smooth and seamless transfer of methods. This collaboration is critical for maintaining consistency and reliability when methods are used in different laboratory settings.
  6. Timely Delivery: We prioritize timely service delivery by establishing project schedules and monitoring progress through regular conference calls. Our dedication to timelines helps clients stay on track with their projects and research objectives.

Our comprehensive range of services in the field of method development, optimization, feasibility assessment, qualification, validation, verification, and force degradation studies demonstrate a commitment to ensuring the accuracy, reliability, and compliance of analytical methods used in the pharmaceutical and related industries. Here’s a breakdown of the key services we provide:

  1. Method Development: We engage our customers in method development by collaborating with clients to define project requirements and scopes. We use of the Quality by Design (QbD) approach to ensure that methods are developed and optimized systematically. We assess various attributes, including accuracy, precision, quantitation limits, detection limits, linearity, solution stability, robustness, and specificity to ensure the suitability of the method for its intended purpose.
  2. Method Optimization: Methods are optimized for various reasons, such as improving peak separation, improving peak shapes, introducing new impurities, lowering detection limits, or supporting route and or formulation changes. Optimization ensures that methods are as efficient and effective as possible.
  3. Method Feasibility: Prior to qualification or validation, we recommend conducting feasibility studies. These studies allow us to become familiar with the method and assess critical attributes like precision, linearity, accuracy, and specificity. This proactive approach helps prevent issues related to protocol acceptance criteria during formal validation.
  4. Method Qualification: Qualification is conducted on methods supporting early-phase products to ensure their suitability for intended use. This stage ensures that methods are reliable and meet basic validation criteria.
  5. Method Validation: We perform phase-specific method validation in accordance with EP/USP general chapters and ICH guidelines. This comprehensive validation process ensures that methods are rigorously tested and meet regulatory standards.
  6. Compendial Method Verification: We offer compendial method verification to ensure that laboratory instruments and procedures can perform compendial testing following established compendial procedures. Additionally, we conduct method comparison studies to demonstrate the equivalence or superiority of client-specific methods compared to compendial methods.
  7. Force Degradation Studies: Force degradation studies are essential for assessing the stability-indicating capabilities of methods used for API and drug product testing. These studies help ensure that methods are suitable for shelf-life studies and compliance with mass balance criteria.

Our services cover the entire lifecycle of analytical methods, from development and optimization to qualification, validation, and verification. This comprehensive approach ensures that our clients can rely on accurate and compliant methods for their pharmaceutical and biopharmaceutical research and production needs.

Overall, we demonstrate a strong commitment to providing high-quality testing and validation services to meet the unique needs of our clients in the pharmaceutical and related industries. These attributes make us a valuable partner for organizations seeking reliable and compliant testing and validation support.

We offer Method Development and Validation Services for:

  • Assay/Potency, Purity/Impurity, Dissolution
  • Genotoxins
  • Cleaning Validation Analysis (Rinse and Swab method development and validation)
  • Residual solvents/Organic Volatile Impurities
  • Excipients

Our documentation services include:

  • Method Validation/Qualification/Verification protocol and report
  • Method Transfer protocol and report
  • Compendial compliance report
  • Method development report
  • Force degradation report

We have well equipped Analytical facility with access to the following state-of-the-art equipment:

  • ‍HPLC- DAD
  • HPLC-MS
  • GC-FID
  • GC-MS
  • ICP-MS, OES
  • 1H NMR
  • 13C NMR
  • 19F NMR
  • 2D NMR, COSY, NOESY, HMBC
  • FTIR/ ATR
  • XRD
  • Karl fisher
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