Application note: Why extractables and leachables matter
Nelson Laboratories, with their unique database of over 6,000 compounds for detection, discuss the testing requirements for extractables and leachables and why identification and quantification in extraction studies will become increasingly crucial for pharmaceutical and medical device product safety and integrity.
To ensure pharmaceutical and other healthcare products retain their value, integrity and commercial longevity companies rely on a delicate balance between quality, safety and efficacy. When issues such as product adulteration disturb that balance, the damage to patients, revenues and corporate reputation can be substantial. Therefore, the pharmaceutical and medtech industries, along with their associated regulatory bodies, are paying increasing attention to testing requirements for extractables and leachables (E&Ls).