Using cutting-edge tech and an expert team, CD Formulation offers in-depth E&L evaluations for nucleic acid meds. Our methods are precisely refined and validated for accuracy and reliability, addressing R&D, QA, and regulatory needs, ensuring your products' safety and efficacy.

About Extractables and Leachables

In the field of nucleic acid medications, examining extractables and leachables (E&L) is crucial for product safety. Extractables are chemical compounds drawn out from packaging or manufacturing parts in labs using various solvents under controlled conditions. On the other hand, leachables are substances that migrate into the medication during normal usage and storage from these systems. Because leachables typically stem from extractables, both are usually examined together to detect and manage chemical impurities that may affect drug safety and effectiveness. Accurate E&L analysis is essential for nucleic acid drugs to meet regulatory standards and ensure product safety and efficacy.

Fig.1 Extractables & leachables analysis services for nucleic acid drugs. (CD Formulation)

Explore Our Extractables & Leachables Analysis for Nucleic Acid Drugs

With state-of-the-art tools and an expert team, CD Formulation offers comprehensive assessments of extractables and leachables, ensuring products do not release harmful agents during use. Our analytical techniques are carefully adjusted and confirmed to ensure accuracy and dependability, meeting the varied requirements of clients in research, quality control, and regulatory adherence.

Volatile and Semi-Volatile Organic Compounds Analysis

We carry out semi-quantitative assessments of volatile and semi-volatile organic substances using GC/MS. The application of direct sample injection alongside electron impact ionization enhances sensitivity and resolution, allowing for precise analysis of organic compounds. Moreover, we adopt headspace sampling to boost analytical accuracy by eliminating intricate pre-treatment procedures and minimizing interference from sample matrices, which guarantees dependable outcomes.

Non-Volatile Organic Compounds Analysis

Our lab utilizes LC/MS to assess non-volatile organic compounds, employing advanced Electrospray Ionization (ESI) technology to effectively detect and measure intricate substances. This strategic combination facilitates extensive coverage and high-throughput analysis, ideal for the detection of various compounds, ensuring an exhaustive assessment of compound profiles.

Typical Workflow of Extractables & Leachables Analysis for Nucleic Acid Drugs

Fig.2 Flow chart of extractables & leachables analysis for nucleic acid drugs. (CD Formulation)

• Risk Assessment

Conduct an initial risk assessment to identify sources of extractables and leachables in drug packaging materials and manufacturing processes that may affect drug stability and patient safety.

• Experiment Design

Develop an experimental plan for identified risk sources, selecting solvents, temperatures, and times that mimic storage and usage conditions of the drug.

• Extraction Experiment

Implement extraction experiments using various solvents, heat, and pressure conditions to detect potential chemicals, using GC-MS and LC-MS instruments for identification.

• Data Analysis and Identification

Identify extracted compounds through mass spectrometry and NMR, confirming them using chemical databases to assess their toxicity or impact on efficacy and stability.

• Reporting and Risk Management

Generate an analysis report with recommendations for material replacement and process optimization to mitigate risks, ensuring drug safety and efficacy.

Our Technology Platforms

Our Advantages of Extractables & Leachables Analysis for Nucleic Acid Drugs

• Tailored to the unique characteristics of nucleic acid drugs, we design customized analytical solutions to ensure precision and relevance in evaluation results.
• By leveraging advanced mass spectrometry and nuclear magnetic resonance technologies, we achieve high sensitivity and resolution in compound detection.
• We employ multi-tiered risk assessment models to deeply analyze the long-term effects of extractables and leachables on the drug.
• We provide comprehensive analytical reports, offering expert recommendations on material selection and process improvement.

Publication Data

If you're interested in our E&L testing for nucleic acid drugs, feel free to contact us. Our team of specialists is ready to offer expert advice and solutions to help you gain an edge in product development and quality control.