Impurities and the unwanted by-products, especially the potentially toxic compounds, should be strictly controlled below a certain level set by the regulatory agencies. That’s mainly ascribed to the fact that these pharmaceutical impurities such as residual solvents and degradation substances have a significant role in the purity, safety and quality of the end products. Nonetheless, the analysis and purification of both drug-related and process-related impurities are always challenged by the extensive sources include the starting materials, contaminants, reagents, catalysts, solvents, intermediates, excipients and the leachables and degradation products. Additionally, the impurities are generally presented at very low levels and sometimes in complex sample matrices, which requires more sensitive and specific techniques and approaches to identify and separate them.
The majority of compounds contain certain amount of impurities and will suffer from a certain extent of degradation during production, storage and transportation. Recognizing the fact that it is inadvisable and costlier to replace these compounds just by re-synthesis or purchasing, utilizing purification techniques or chemical transformations to reclaim the pure compounds, therefore, represents an alternative approaches that is more efficient and rapid.
Although the optical isomers in a chiral compound have the same physical and chemical characteristics in general, they will exhibit marked differences in the pharmacological and toxicological activities. Chiral separation and analysis of racemic drugs is therefore of great importance in the pharmaceutical and chemical industry. Our scientist are professional in the field of chemosynthesis, analysis, purification and separation. Combined with the state-of-the-art facilities in our laboratory, BOC Sciences can offer our global customer with the most efficient chiral analysis and separation services to support your project management.
As one of the most key elements for any pharmaceutical development program, analytic method development, validation, and transfer play an essential role in many aspects such as controlling the quality, ensuring the safety and improving the potency of products. These activities are interrelated and iterative particularly during early drug development phases.
fully aware of the importance of technological updating in the rapid developing and intensely competitive market, BOC Sciences is always at the forefront of technology. Furthermore, our analysts, technicists and chemists have a strong desire to keep up with the latest trend. To satisfy your requirements of product’s analysis or submission, various top-notch instrumentations are accessible in the laboratory of BOC Sciences, which mainly include:
Why choose BOC Sciences?
On the basis of the network of state-of-the-art laboratories, scientists from BOC Sciences can provide our customers with a comprehensive range of analysis and purification services. With decades of expertise in the testing, inspection, verification and certification for a wide array of industries, our consultants can assist you to conduct a suite of high-quality assessments to address the issues associated with impurity identification and separation. Besides, our highly trained chemists, material scientists, analysts and technicians will work cooperatively to make your customized and innovative analysis services more efficient and timely. In the end, our staff will offer you the collected data which are required to complete relevant risk assessments for meeting the submission requirements.