Organic solvents may be used in drug development and manufacturing to increase yield, form desired crystals, improve dissolution and optimize disintegration processes. Residual solvents for pharmaceutical products refer to the organic volatile chemicals used and produced in the production process of APIs, excipients and formulations. Residual solvents cannot be completely removed from the process and are not used as excipient solvents.
Many organic solvents have certain harm to the environment and the human body. Therefore, to ensure drug quality and drug safety, as well as protect the environment, it is necessary to research and control residual solvents.
Classification of Residual Solvents
ICH Q3C(R8) guidelines categorize residual solvents into four categories. For solvents in the Class Ⅰ, if they cannot be avoided in the production of a pharmaceutical product with significant efficacy, they should be controlled below the limit level.
Our Services
We provide residual solvent research services for the majority of drug manufacturers to ensure the safety of drugs in accordance with national regulatory guidelines to speed up the process of drug development and marketing.
Our company has a complete residual solvent research platform, a variety of brands of GC instruments, and a full range of detectors (FID, TCD, ECD, etc.). We provide method development and validation for a wide range of residual solvents for pharmaceutical companies and research institutions worldwide, and we can also perform sample testing according to existing methods. Our residual solvent testing and research targets include formulations, APIs, and excipients. The ultimate purpose of controlling the residual solvent of APIs and excipients is to control the residual solvent of the preparation.
Our Service Process
1. Determine the research object of residual solvent
Although the organic solvents used in the drug preparation process are theoretically possible residues, through the information provided by customers, we can conduct scientific analyses of the nature of organic solvents, drug preparation technology, etc., and selectively study the residual amount of some solvents. This can not only reasonably and effectively control product quality, but also help to reduce the time and cost of drug research and avoid unnecessary waste.
2. Determine the types and limits of residual solvents
Determine residual solvent categories and limits according to ICH guidelines. If the solvent is not included in the first three categories, we query the NOEL and calculate the PDE and limits.
3. Development and validation of residual solvent determination methods
GC method has high sensitivity, excellent selectivity, less sample amount, and can meet the requirements for residual solvent determination. In the process of method development, we combine the properties of the drug and the solvent to determine the appropriate detection conditions. The conditions considered in the development of our residual solvent determination methods include the following.
- Sample preparation method
- Internal target selection
- Injection method
- Detector
- Detection parameters (column, temperature, shunt ratio, etc.)
Because many solvents are usually detected at the same time, the method developed by us can control as many kinds of residual solvents as possible under the same detection conditions for operational feasibility and simplicity. We can provide residual solvent method validation services to confirm the specificity, detection limit, quantitation limit, linearity, accuracy and durability of the method.
4. Test samples and determine the control policy
We test for residual solvents in representative batch samples from pharmaceutical manufacturers according to confirmed methods. We analyze the test results and, based on the formulation process, advise companies on residual solvent control strategies.
- Rotational speed
- Drift value
- Initial drift value
- Drift correction
- Extraction time
