Creative BioMart Chromatography has a perfect pharmaceutical impurity isolation technology platform, which provides customers with high-quality, high-speed impurity isolation services. We are good at solving various difficult separation problems, and our expertise in isolating and identifying impurities plays a vital role in helping our customers research, develop and produce high-quality pharmaceutical products. Our solutions include but are not limited to SPE, Liquid-liquid extraction, ASE, SFE, TLC, GC, Flash chromatography, HPLC, HPTLC, Capillary electrophoresis (CE), etc.
Unknown impurities occur at all stages of the R&D life cycle in both the API and the drug. Impurity control is one of the most important contents of drug quality control. The adverse reactions in clinical use of drugs are often related to impurities in the products. Whether the impurities in drugs are fully and accurately controlled will directly affect the quality control and safety of listed drugs. The preparation and Isolation of drug impurities are the most direct means of impurity research. We can expand customer-specific methods or develop reproducible purification methods for your products and API. By preparing chromatography and other techniques, the required pure impurities can be quickly separated, and then the qualitative, quantitative and safety studies can be carried out. The ICH Q3 guidelines for Impurities in New Drug Substances (Q3A(R2)) and for Impurities in New Drug Products (Q3B(R2)) state that degradation products observed during manufacturing and stability studies, conducted at the recommended storage conditions, should be identified when present at a level greater than the identification thresholds given in the following table.
| Guidelines | Maximum Daily Dose | Reporting Threshold | Identification Threshold | Qualification Threshold |
|---|---|---|---|---|
| Q3A(R2) | ≤2 g | 0.05% | 0.10% or 1.0 mg / day intake | 0.15% or 1.0 mg / day intake |
| Q3A(R2) | >2 g | 0.03% | 0.05% | 0.05% |
| Q3B(R2) | ≤1 g | 0.1% | - | - |
| Q3B(R2) | >1 g | 0.05% | - | - |
| Q3B(R2) | <1 mg | - | 1.0% or 5 µg TDI | - |
| Q3B(R2) | 1 mg -10 mg | - | 0.5% or 20 µg TDI | - |
| Q3B(R2) | >10 mg - 2 g | - | 0.2% or 2 mg TDI | - |
| Q3B(R2) | >2 g | - | 0.10% | - |
| Q3B(R2) | <10 mg | - | - | 1.0% or 50 µg TDI |
| Q3B(R2) | 10 mg - 100 mg | - | - | 0.5% or 200 µg TDI |
| Q3B(R2) | >100 mg - 2 g | - | - | 0.2% or 3 mg TDI |
Impurity Isolation Process
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Creative BioMart Chromatography has accumulated rich experience in isolating and identifying pharmaceutical impurities over the decades of development. The complete set of equipment and professional technology ensure the quality and efficiency of impurity isolation service, which can provide strong support for your new drug application or existing drug quality improvement. Our customers have direct access to our experts and give timely feedback to any online inquiries. If you are interested in our services, please contact us.
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