Quality Assurance of Excipient

The quality of medicines not only depends on the active ingredients and production process, but also is closely related to the property of excipients. To ensure that excipients are able to perform important and specific technical functions, in addition to their identity, purity and strength testing, standardized process of quality controls are required. Numerous studies have shown that variability and the presence of safety-related substances of excipient may pose risks to patients. Therefore, research on drug safety has mainly focused on the risks that excipients may pose to patients, which demonstrates the importance of safety assessment of excipients. Each excipient should contain the information needed to support the the risk assessment and evaluation. Furthermore, in order to develop available drug products, it is important to study the variability of excipients and their impact on the finished product, which can be understood by studying key parameters that affect the functional performance of a drug product. Over the past few decades, our team has invested in fundamental excipient research and developed novel excipient quality assessment protocols and analytical tools. Our quality control program aims to ensure the continuous and stable production of excipients that meet the intended purpose and usage requirements.

Figure 1. The risk assessment of excipients. (Bernini, C. 2016）

BOC Sciences Quality Control and Assurance

BOC Sciences can advise clients on issues relating to the potential hazard and stability of the excipient, and we invite you to contact our experts to learn more about our services.

Safety Assessment of Excipients

With the introduction of new analytical techniques and an increased understanding of the importance of how some chemical components can increase the risk of excipient use, there is an awareness of the need to accurately evaluate the safety of excipients, especially for new ones). With our experts' expertise and rich experience in the identification of the potential hazards of excipients (e.g., impact on drug production, impurities, stability, etc.) and the potential hazards to patients (e.g., impact on drug bioavailability, patient acceptance, presence of contaminants, etc.), BOC Sciences provides complete and standardized safety testing solutions, which are performed by considering the following factors: microbial hazard assessment, chemical hazard assessment, and physical hazard assessment to determine if the excipient has potential microbial, chemical (toxicological, pathological effects), or physical (asphyxiation, irritation) hazards.

Evaluation of Excipient Variability

Many excipients have some inherent variability that may come from a variety of sources. In addition, the variability of some excipients may also be influenced by degradation, packaging and/or environmental conditions during storage and distribution. The various components of a drug are affected by excipients to varying degrees. Therefore, a hazard-based and scientific approach is required to control the fluctuation of excipients. BOC Sciences offers variability evaluation services that apply a variety of advanced analytical tools to identify excipient properties that may have an impact on the performance of products. Our unparalleled insight and skill can provide internally and externally documented information to identify essential excipient properties that may affect drug functionalities and uses.

Why Choose Us?

• Our scientific, safe and compliant quality control strategies have proven to be useful in the delivery of qualified excipients
• Our services of quality control cover all the quality management activities, and the well-established system is continuously monitored, reviewed, and updated on a regular basis to ensure efficient operation
• Regulatory compliance is the priority to ensure the reliability of laboratory data management