Creative BioMart Chromatography provides impurities analysis services during the manufacturing process of pharmaceuticals and biopharmaceuticals. Whether the impurities in drugs are fully and accurately controlled will directly affect the quality control and safety of listed drugs. Impurities can take many forms, from solids to volatiles and everything in between, include organic impurities, inorganic impurities and residual solvents, which are found in starting materials, intermediates, APIs, and by-products. In addition, we also offer pharmaceutical impurity isolation service. By preparing chromatography and other techniques, the impurities can be quickly separated, and then the qualitative, quantitative and safety studies can be carried out. Our impurities analysis is carefully following the ICH guidelines to apply a range of highly specific and sensitive techniques, and will also be customized from batch to batch variation (Fig. 1). Our solutions include but are not limited to SEC, LC-MS, LC-MS/MS, UPLC, HPLC, HPTLC, GC, GC-MS, UV/Vis spectrum, ICP-OES, ICP-MS, etc.
Fig. 1 Example for qualification of a known impurity in case the clinical batch and the batch for supportive toxicity studies are different. (Teasdale A., et al, 2017)
Impurities Analysis Techniques
| Impurities Type | The Main Source | Methods | Consumables |
|---|---|---|---|
| Ordinary impurities | Starting materials, intermediates, by-products, degradation products | HPLC | C18 columns, Amino columns |
| Chiral impurities | Compounds containing chiral centers, reactions that introduce chiral | HPLC, Polarimeter | Chiral columns |
| Genotoxic impurities | Starting materials, intermediates, by-products | HPLC | C18 columns, Capillary columns |
| Heavy metal impurities | Metal catalyst | ICP-OES, ICP-MS | Single element standard solutions, mixture element standard solutions |
| Residual solvent | Reaction solvent, post-treatment solvent, by-products | GC | Capillary columns |
| Inorganic salt | Desiccant, pH regulating agent, acid binding agent | Turbidimetry, colorimetry | The corresponding analytical reagents |
Our Specialty
- The technical team is experienced in testing and arranges the experiments in a timely and rigorous manner.
- A wide range of chromatography techniques (HPLC, UPLC, GC, and IC) and detection technologies to meet the requirements of different types of compounds.
- End-to-end services with high quality and fast turnaround time to ensure accurate and reliable analytical data.
- Perfect and thoughtful pre-sales and after-sales service, and timely solve customers' questions.
Creative BioMart Chromatography has extensive scientific knowledge and experience in pharmaceutical impurities analysis with the regulatory requirements of the international markets, which provides strong support for new drug applications or existing drug quality improvement. We also provide custom services to meet the customer’s special needs. 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.
How to Place an Order
*If your organization requires the signing of a confidentiality agreement, please contact us by email.
Reference:
- Teasdale A., et al. (2017). Impurities in New Drug Substances and New Drug Products. ICH Quality Guidelines, 167–198.
For Research Use Only. Not intended for any clinical use. No products from Creative BioMart may be resold, modified for resale or used to manufacture commercial products without prior written approval from Creative BioMart.