Safety Assessment of Excipients

Nowadays, excipients play a key role in the production of final dosage forms of pharmaceuticals, and they are no longer characterized simply as inert components. To ensure the safety of public medication, the safety assessment and quality control of excipients have become important parts of the pharmaceutical quality system. Regulatory requirements demand pharmaceutical manufacturers to apply complete and standardized safety assessments to ensure the suitability of excipients.

Figure 1. The importance of safety of excipients in the efficacy and functionality. (Ramesh,K.; et al. 2019）

Our experts provide a systematic and accurate evaluation of excipient quality, helping you to make more effective decisions. The safety assessment is performed by considering the following factors:

• Categories of excipients
• The role of excipients in finished products
• Routes of administration

Our Capabilities

At BOC Sciences, the safety of excipient is evaluated based on the harm posed by microbiological, chemical (toxicological, pathological effect) or physical (choking, irritation) hazards.

Microbiological Hazards Assessment

Microorganisms such as molds, viruses or bacteria in excipients can pose a threat to patient health, so the confirmation of the microbiological quality of excipients is an important part of the quality assessment of excipients. More and more pharmaceutical companies are choosing to work with BOC Sciences to ensure that their final drug products meet regulatory standards. We offer best-in-class excipient microbiological hazard assessment services:

• Microbial Limit Testing (MLT): Qualitative and quantitative testing of microorganisms to determine whether your excipients meet the established microbiological quality specifications
• Testing for total bioburden and the presence of specific microorganisms
• Determination of microbial contamination

Chemical Hazards Assessment

At BOC Sciences, chemical hazard assessment of excipients is accomplished by measuring toxicological and pathological effects of excipients. Our experts provide safety assessment analysis for a number of common and novel excipients including identification of excipients causing toxicity (compounds of regulatory concern), assessment of the potential toxicity of an excipient, and assessment of the toxic effects of an excipient on the population as a whole or on a specific population. In addition, we provide additional services to determine if an excipient affects common clinical pathological endpoints.

Physical Hazards Assessment

Some physical hazards of excipients such as choking and irritation can cause harm to the human body. To avoid some drug dosage forms causing dysphagia, choking and irritation to patients, it is necessary to test the flow properties and allergic reactions of the drug. We use scanning electron microscopy (SEM) technique to provide characterization services for the flowability of common excipients, as well as other measurements of relevant flowability-related parameters and moisture content measurements. BOC Sciences can also provides complete irritation testing to determine if your excipients have potential in causing local irritation response.

Our Excellent Insights

The trust of our customers is established based on BOC Sciences' knowledge and expertise in the reliable safety assessment of excipients. Our capabilities include but not limited to:

• Knowledge of manufacturing process
• Complete understanding of the potential hazards of excipients used in pharmaceutical products (e.g., impact on drug product manufacturing, impurities, stability, etc.)
• Knowledge of the potential hazards to the patients from excipients used in drug products (e.g., impact on bioavailability of the drug, patient acceptance, presence of contaminants, etc.)