Impurities Control of Excipients

Impurities in excipients causes physical changes (e.g., covalent aggregation) or chemical changes in drug components (e.g., oxidation). When impurities are identified above threshold levels, production stops and excipients must be re-evaluated, which will increase the production costs and time to market. Therefore, to ensure the purity, quality and safety of excipients, analytical testing must be performed quickly and accurately to determine if any impurities are present in the excipients. BOC Sciences' advanced analytical tools provide reliable data to mitigate compliance risk to identify the potential impurity and ensure your excipient quality.

Our Capabilities

Testing for Residual Solvent in Excipients

Residual solvents are a kind of organic volatile chemicals that do not have any therapeutic effect, and should be removed to the extent possible to meet the specifications of the final drug product. We use GC-MS for complete and reliable testing of residual solvents in excipients to ensure that the final drug product is free of toxic volatile organic compounds.

Testing for Trace Metals in Excipients

Routine screening of excipients needs to be robust and sensitive enough to detect low levels of impurities. Metal impurities are rightly a cause for concern, and the detection of metal impurities is a necessary requirement in pharmaceutical manufacturing. BOC Sciences’ skilled and experienced analytical chemists, supported by well-equipped laboratories, can extract and identify the rogue peak in the samples by employing a variety of atomic spectroscopy techniques to analyze metal contaminants.

Testing for Microbiological Impurities in Excipients

Microbial impurities in the pharmaceutical excipients used to manufacture drugs may affect the outcome of the processing steps of the drug and the microbial characteristics of the final drug product. Therefore, to ensure patient’s safety, stringent microbial contamination control measurements are widely used in many drug formulations. BOC Sciences provides comprehensive analysis services for microbial impurities in excipients through complete isolation, testing and identification of a wide range of microorganisms (bacteria, yeasts and molds). Our capabilities include:

Testing for Reactive Impurities in Excipients

Depending on the application and processing factors of excipient, the presence of reactive impurities in excipients can affect the safety and efficacy of pharmaceuticals even in trace amounts, especially for low dose drugs. For different reactive impurities, our experts apply different chromatographic methods to perform testing:

• We use high performance liquid chromatography (HPLC) to determine trace levels of reducing sugars in excipients
• For trace levels of volatile impurities in pharmaceutical excipients, headspace-based gas chromatography is used to detect and quantify the amounts of fatty aldehydes and benzaldehyde in excipients
• We offer HPLC-based determination of hydroperoxide (HPO) impurities for the measurement of HPO in pharmaceutical excipients
• GC/MS and ion exchange chromatography methods are used to measure organic acids in excipients

Explore Our Instruments

• Chromatography

No matter what regulatory requirements you are facing, we have a wide range of chromatography solutions to solve your separation and detection challenges. Our diverse portfolio of services include liquid chromatography (LC), liquid chromatography/mass spectrometry (LC/MS), gas chromatography (GC) and gas chromatography/mass spectrometry (GC/MS). In addition, we offer the most comprehensive pre-treatment solutions for your impurity samples including headspace (HS), liquid injection and solid phase microextraction (SPME) techniques.

• Atomic Spectroscopy

BOC Sciences is equipped with the world's leading Atomic Absorption Spectroscopy (AA), Inductively Coupled Plasma (ICP-OES), Inductively Coupled Plasma Mass Spectrometry (ICP-MS)-Atomic Analysis Systems to provide our customers with fast and efficient inorganic elemental analysis of impurities. Our atomic spectroscopy platforms are designed to meet the practical application needs of our customers, ensuring accurate multi-element analysis is achieved.