Impurity Analysis for Nucleic Acid Drugs

CD Formulation has an impurity profiling database, a core technical team, and a technical platform for nucleic acid drugs analysis. The company is dedicated to offering objective, professional, and efficient laboratory R&D and analytical technical support for global pharmaceutical companies. Our services cover trace metals, extracts and leachates, residual solvents, etc., providing high-quality, high-efficiency, and comprehensive solutions.

About Impurity Analysis of Nucleic Acid Drugs

Nucleic acid drugs are typically synthesized through solid-phase synthesis. Due to the intricate nature of their molecular structure, various impurities are easily formed during production. Detecting, identifying, quantifying, and controlling impurities in nucleic acid drugs are crucial steps to enhance the purity, safety, and quality control of the drug substance or final product. Impurities in nucleic acid drugs can originate from different sources, such as starting materials and their contaminants, reagents, solvents, leachables, and degradation products. The impurities may be organic (both resulting from the process and from the drug itself), inorganic, or elemental. The presence of these impurities is often in very small amounts or in trace amounts in highly complex sample matrices, therefore precise analytical methods are needed to determine their levels. This data is necessary for conducting the associated risk assessment or meeting submission requirements.

Fig. 1 Nucleic acid impurity ions revealed by high-resolution mass spectrometry. (Abdullah A M, et al., 2023)

Explore Our Impurity Analysis Services for Nucleic Acid Drugs

CD Formulation's laboratories offer pharmaceutical impurity testing for nucleic acid drug formulations, supporting your product development from early stages and throughout the drug product lifecycle. Our scientists specialize in method development and validation of appropriate analytical procedures, providing expertise in addressing extractables and leachables, detecting elemental impurities, analyzing residual solvents, and identifying process-related impurities.

Our experience encompasses all nucleic acid drug formulations, product classes, and drug delivery technologies. The insights we gain from reliable analytical studies can support your corrective and preventive action programs, accelerate your drug development programs, and streamline manufacturing impurity monitoring.

Our available services include:

Trace Metals Analysis

Trace metals analysis in nucleic acid drugs is vital for ensuring drug safety and efficacy. Trace metals can catalyze degradation of nucleic acids, affecting stability and potency. Identifying and quantifying these metals helps in optimizing the formulation and manufacturing processes to minimize potential adverse effects.

Residual Solvent Analysis

We offer expert analysis and identification of residual solvents in pharmaceutical products to assist our clients in verifying that residual solvents have been minimized to acceptable levels, ensuring that final products comply with the limits outlined in ICH Q3C(R5) or USP <467>/ Ph. Eur. 5.4, or limits established by the pharmaceutical manufacturer for specific solvents.

Extractables/Leachables Analysis

Our experts have more than years of experience in specialized analysis and toxicological evaluation of extractables and leachables. Our knowledge of packaging materials enables us to identify components from even the most complex polymer formulations.

Our Impurity Analysis Technologies for Nucleic Acid Drugs

With scientists specializing in method development and validation of appropriate analytical procedures, we can overcome the challenges of low detection levels and complex impurities. Using a range of techniques, we can apply orthogonal methods to ensure robust, specific, and sensitive analysis. Our comprehensive range of characterization techniques includes:

• Capillary Gel Electrophoresis (CGE) Technology
• High-Performance Liquid Chromatography (HPLC) Technology
• Ion Pair High-Performance Liquid Chromatography (IP-HPLC) Technology
• Inductively Coupled Plasma Mass Spectrometry (ICP-MS)Technology
• Nuclear Magnetic Resonance (NMR) Spectroscopy

Our Workflow of Nucleic Acid Drugs Impurity Analysis Services

Fig. 2 Our workflow of nucleic acid drugs impurity analysis services. (CD Formulation)

Why Choose Us for Impurity Analysis?

• We have a high-quality and stable customer base, and we can cooperate with scientific research institutions and international multinational companies to enhance our management and operational capabilities. This will enable us to introduce more products with significant market potential, advanced technology, and high added value to the market.
• We offer comprehensive expertise in quality assurance for nucleic acid drug impurities to assist you in meeting and surpassing quality, safety, and regulatory standards.
• Relying on our various technologies and equipment, we are able to provide our customers with analysis of organic and inorganic impurities to assist in the development of nucleic acid drugs.

Publication Data

CD Formulation will accelerate the progress of collaborative projects with our professional technical team, rich project experience, and advanced analytical instrumentation to ensure strict quality assurance at every stage of the project. If you are interested in our services, please feel free to contact us.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.