CD Formulation possesses extensive experience and expertise in providing long-term stability analysis services for nucleic acid drugs. Utilizing cutting-edge methods, we conduct detailed and precise assessments of nucleic acid drug stability across diverse environmental conditions, ensuring their performance and safety throughout storage and use.

Why Conduct Long-term Stability Analysis for Nucleic Acid Drugs?

The main objective of conducting long-term stability tests for nucleic acid drugs is to confirm the drug's safety and effectiveness in real storage conditions. Evaluating stability helps set valid expiration dates, ensuring patient use remains effective and safe. Typically, these tests are performed in controlled settings like 25℃±2℃ with 60%±5% humidity, or 30℃±2℃ with 65%±5% humidity, mimicking real-life storage scenarios. Such tests can uncover potential degradation or adverse changes during storage, offering scientific backing for determining expiry dates and storage guidelines.

Table 1. Conditions for Long-term Stability Analysis of Different Formulation Types

Considerations for Designing Long-term Stability Analysis of Nucleic Acid Drugs

Explore Our Long-term Stability Analysis Services for Nucleic Acid Drugs

Fig.1 Our long-term stability analysis for nucleic acid drugs. (CD Formulation)

Phys-Chem Stability Analysis

Perform assessments on nucleic acid drugs to gauge chemical stability and physical properties under varying environmental settings. This includes evaluating stability across diverse temperature, moisture, and illumination scenarios. Standard methods like HPLC and MS are employed to identify breakdown products during storage.

Packaging Stability Testing

Identify suitable packaging materials and determine optimal storage conditions to ensure the long-term stability of drugs. The protective effects of different packaging materials such as glass, plastic, etc., may vary under different storage conditions.

Microbial Stability Testing

Monitor microbial growth during long-term management to maintain sterility. Employ microbial detection methods including PCR to identify potential contamination sources and risk factors.

Storage Condition Optimization Services

Design and verify optimal storage conditions based on stability study results to maximize drug shelf life. This process includes simulating the impact of various environmental factors on drugs to propose specific storage guidelines, such as temperature control and packaging material selection.

Analysis Process

Workflow of Long-term Stability Analysis Services for Nucleic Acid Drugs

Fig.2 Flow chart of long-term stability analysis for nucleic acid drugs. (CD Formulation)

• Sampling and Preparation

Determine appropriate sampling intervals, ensuring consistent sample preparation and storage conditions to avoid deterioration and data deviation due to environmental and operational factors.

• Physico-chemical Analysis

Regularly analyze physico-chemical properties such as pH value, solubility, solution clarity, and concentration to detect any changes in substances or solutions.

• Biological Activity Assay

Evaluate drug persistence using biological assays. For example, evaluate the functional activity of nucleic acid drugs using appropriate in vitro or in vivo models.

• Degradation Product Analysis

Detect potential degradation products using HPLC and MS, understand the degradation process and its impact.

• Data Analysis

Systematize the obtained data, perform statistical analysis and kinetic modeling to predict stability and efficacy changes under long-term storage conditions.

Our Technology Platforms

Our Advantages of Long-term Stability Analysis Services for Nucleic Acid Drugs

• We provide high-precision stability test data through advanced analytical technologies and instruments, helping to identify potential instability factors.
• An experienced team of experts can tailor test plans based on drug characteristics to ensure scientific and comprehensive analysis.
• We offer efficient test processes and flexible scheduling, ensuring detailed and reliable results while meeting time requirements.
• We provide compliance analysis reports in line with international and industry standards and regulations to support drug registration and market promotion.

Publication Data

For inquiries or interest in our offerings, please contact us at your convenience. Our skilled team is committed to delivering timely support and ensuring your requirements are swiftly addressed.