Diabetes affects over 30 million Americans and its prevalence is growing around the world. It is a leading cause of death in the United States1 and the mortality rate is increasing globally. If not properly managed, diabetes can lead to cardiovascular disease, limb loss, organ failure, and blindness.2 For many diabetics, insulin is the only treatment option for controlling their blood sugar levels.
USP maintains 16 insulin monographs, 7 reference standards, and 2 general chapters. USP quality standards for insulins cover a broad range of requirements.
Insulin monographs focus primarily on three areas:
- Identity
- Validated tests and physical reference standards to establish the molecular identity of the drug product or drug substance.
- Potency
- Validated tests and physical reference standards to establish the potency of the insulin drug substance and drug product in Units/mg or Units/ml.
- Purity
- Tests and physical reference standards to assess aggregate formation. Aggregates are not biologically active and therefore impact insulin potency. Aggregate formation is time and temperature dependent and can significantly impact product shelf life.
- Tests and physical reference standards to support analysis of insulin degradation products. Like most biological products, insulins are susceptible to chemical degradation, which is dependent on time, temperature, and pH.
References
1. Diabetes Report Card 2017. (Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 2018).
2. National Diabetes Statistics Report, 2017. (Division of Diabetes Translation, National Center for Chronic Disease Prevention and Health Promotion, Atlanta, GA, 2018).
Read more
