To produce high standard quality pharmaceutical products, efficient removal of the unwanted by-products such as solvent residual, degradation impurities is significantly important. Generally used approaches to achieve pure products can be classified into distillation, crystallization and precipitation. However, separation of certain organic impurities and chiral compounds is an extremely complex process and needs more effective techniques such as the chromatography-based approach.
SMB technology is a continuous process that combines a suit of advantages such as high yields, high purity and accelerated scale-up. By utilizing such technology, BOC Sciences is able to conduct a separation from 10kg to 10s MT.
SFC is an approach using supercritical carbon dioxide as the solvent, which is suitable for small to larger (-10kg) separation.
As the simplest and quickest method, HPLC is commonly used to obtain small scale (mg to-multi g) samples and over 90% of chiral substances can be separated at this scale.
Liquid chromatography (LC), gas chromatography (GC), capillary electrophoresis (CE), and magnetic resonance spectroscopy (NMR).
Pharmaceutical impurity identification and isolation is a critical process to ensure the API’s or final product’s quality, safety, and the ultimate submission. Organic impurities can be produced in the degradation process, but also in the chemical process. Inorganic impurities may come from reagents or catalysts, salts or excipients. Residual solvents in drugs, substances, or products may come from any step in the chemical or manufacturing process. Any of these may come from packaging, labelling, transport or other exposure to external pollutants. Therefore, impurity separation is very necessary.
In the complicated process of API synthesis and formulation development, it is unavoidable that many kinds of impurities, such as the unreacted materials, intermediates, reaction solvents, and even the chromatographic media used in purification, will be produced. A comprehensive understanding of the process-related impurities is necessary to establish acceptance criteria for ongoing testing requirements.
Organic impurities are generally represented by the by-products or residual substances composed of organic molecules such as acrylamide, aliphatic and aromatic solvents, glycol ethers, organotin derivatives, and furans.
Solvent residuals are those organic volatile chemicals that do not provide therapeutic benefit, and may cause unacceptable toxicities. In this case, it is pivotal to conduct the residual solvents testing for drug substances, excipients, and drug products to ensure the pharmaceutical’s quality and safety.
Extractables and leachables (E/L) represent the harmful leachable impurities from container closure systems, manufacturing equipment, and packaging-related contaminate.
A full range of degradation impurity testing helps optimize the manufacturing process, select the most appropriate excipients or drug solid forms, and establish an acceptable storage condition.
BOC Sciences enables scientists to identify the impurity in a highly efficient way by equipping with a wide array of analytical methods and technical platforms including but not limited to gas or liquid chromatography and mass spectrometry. (HPLC, RP LC, NMR, LC-MS/LC-MS-MS, GC-MS/GC-MS-MS, ICP-OES/ICP-MS).