Drug Product Release Testing
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Drug product release testing is essential to ensure the quality, safety, and efficacy of pharmaceutical products before they are released to the market. CD Formulation provides our customers with drug product release testing for raw materials, active pharmaceutical ingredients (APIs), final products, and biologics, including but not limited to assay, impurities, dissolution, content uniformity, stability, and microbial contamination testing.
What is Drug Product Release Testing?
Given that raw materials, APIs, and final products are subject to some degree of batch-to-batch variation, manufacturers must conduct drug product/batch release testing before any drug is used in clinical trials or for market consumption. Drug product/batch release testing is a quality control process that involves testing a specific batch or lot of drug substance or finished product to ensure that they comply with regulatory requirements before being released for distribution or sale. This testing typically requires an analytical evaluation of chemical, physical, and biological product quality based on a validated compendial (e.g., USP) testing strategy to address product purity, concentration, consistency, identity, and safety. Typical testing includes appearance, analysis and impurity, dissolution, and microbiological testing. Batch release testing is an important step in ensuring the quality and safety of pharmaceutical products before they are marketed.
Explore Our Drug Product Release Testing Services
CD Formulation has extensive expertise in performing release testing of pharmaceutical products, including raw materials, APIs, final products and biologics. Our experts perform drug release testing using a wide range of analytical techniques to ensure your product is of high quality before it is marketed.
Additionally, we have the ability to create test protocols that are robust to ensure the safety and integrity of your product and are repeatable to minimize out-of-spec or out-of-trend duplication.
Typical Drug Product Release Testing Program:
Stability testing is used to check the quality of a drug over time and under specific conditions of temperature, humidity and light, and provides important information on best practices for storage conditions and duration to ensure the safety and effectiveness of the drug.
Conducting extractable and leachable testing is critical to identifying and quantifying potentially harmful leachable impurities. These testing can help identify whether hazardous substances are present in a sample and further ensure product safety and compliance with regulatory requirements.
- Leachable testing involves exposing the sample to an appropriate solvent and then leaching it under certain conditions (such as time, temperature, etc.) to determine the concentration or properties of the measured leachable components.
- Extractable testing involves contacting the sample with a specific extractant (such as an organic solvent) and using appropriate methods to separate the target compound from the mixture for analysis.
Dissolution testing involves measuring the rate at which the active ingredients in a pharmaceutical product dissolve in a specified medium, while disintegration testing is used to evaluate how quickly a drug product breaks down into smaller particles when exposed to a specific medium.
Moisture content levels are a critical factor affecting the physical properties and quality of pharmaceutical products at all stages of development and in the final product. High moisture content can also cause the drug to degrade more quickly, so it needs to be carefully monitored and controlled.
The size, distribution, and shape of the particles will affect the overall performance, stability, and appearance of the final product. Apart from helping to determine the optimal preparation process and ingredient ratios to ensure the product has the specific properties required, particle analysis can also help ensure the stability and consistency of the final product.
Conducting impurity and residual solvent analysis is an important step to ensure drug efficacy and safety.
- Impurity analysis can detect impurities that may be present in a drug and help ensure its purity and quality.
- Residual solvent analysis can detect residual solvents in drugs to ensure that no harmful substances are introduced during drug preparation and ensure the safety of drugs.
Conducting viscosity analysis is a critical step in ensuring formulation design, manufacturing, storage, and shipping. The viscosity of various drug products, including creams, ointments, syrups, suspensions, emulsions, coatings, gels, semi-solids, and biologics, must be evaluated, monitored, and maintained from batch to batch to ensure product production and performance consistency.
TOC testing is a common analytical technique used in the pharmaceutical industry to measure the amount of carbon present in organic compounds, including pharmaceuticals. The testing is often used to determine the purity of a drug substance and detect any potential impurities that may be present.
XRD/DSC analysis are two commonly used techniques for analyzing the structure and thermal properties of compounds. XRD provides information about the crystal structure of a compound, and DSC provides information about the phase transition, melting point, heat capacity, and thermal stability of the compound.
In vitro release testing is performed to evaluate the rate and extent of drug release and to ensure the quality and performance of the dosage form. This testing provides valuable information about the drug release profile, including release rate, release mechanism, and how factors such as formulation and manufacturing process affect drug release. This information can be used to optimize drug formulations, ensure consistency, and meet regulatory requirements.
It is worth mentioning that our scientists regularly study NCE and enrich our in-house method library according to ICH guidelines. In addition to providing drug release testing, we also provide corresponding analytical method development, validation, and transfer services.
Why Choose CD Formulation for Drug Product Release Testing?
CD Formulation has an approved and accredited analytical testing laboratory with a long history in drug release testing. We provide our clients with the highest level of service under strict cGMP compliance to ensure their pharmaceutical quality control testing is successfully performed.
- Key analysis techniques: LC/MS/MS、UPLC（TUV、PDA、SQD）、HPLC（UV、PDA、FLU、ELSD、RI）、GC、GPC、SEC、KF、TOC、Maldi-TOF...
- Test range: Capsules (IR/SR), injections, inhalers, liquids, patches, suppositories, suspensions, emulsions, creams, ointments, syrups, tablets...
- Test type: Batch release testing and lot release testing for raw materials, APIs, finished products, and biological products.
At CD Formulation, we understand the importance of timely and precise release testing to ensure the safety and efficacy of pharmaceutical products. Our dedicated team is committed to providing reliable and comprehensive release testing services to help our clients bring high-quality products to the market. Contact us today to learn more about our release testing capabilities and how we can assist you with your pharmaceutical development needs.
Please note: Our products and services are not intended to be used directly in diagnostic or therapeutic procedures.
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