E&L Testing (Extractables and Leachables Testing) Service

Attention pharmaceutical, medical device, and packaging device manufacturers anticipating strengthened E&L regulations for domestic sales products.

Our company can conduct E&L testing using analysis equipment managed in compliance with GMP regulations. E&L testing is already essential for applications in the United States and Europe. Recently, it has begun to attract attention domestically due to the rapid growth of the non-oral pharmaceutical market. 【Features】 ■ Over 15 years of experience in E&L testing as part of the Eurofins BPT (BioPharma Product Testing) network ■ Possession of a unique spectral database (LC/MS) capable of identifying over 1,900 compounds ■ Ownership of analysis equipment managed in compliance with GMP regulations ■ Conducting tests domestically with communication available in Japanese Our company transfers over 15 years of experience and extensive know-how from overseas labs to provide suitable guideline selection that meets the needs of various customers in Japan, planning evaluation and management methods according to risk, setting testing methods, and designing long-term leachables testing. Additionally, we offer consultations on stability testing, which has over 20 years of experience, as part of our projects, providing a total solution for approval applications. For more detailed information, please refer to the "Related Links."

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