在过滤器泄露测试中, FDA规定需要什么类型的PAO油?
时间:2012-03-01 阅读:458
FDA的cGMP中,了PAO油的类型并且被批准作为一个DOP的替代.
"The Chemical Abstracts Service (CAS) number which identifies this product also remained as 68649-12-7. Other reported alternatives used in the industry include DOS (Di-(2-ethylhexyl) sebacate) and Ondina Oil. However, no manufacturer has yet submitted all the necessary data to evaluate these alternatives. As such, Emery 3004 PAO with the CAS number 68649-12-7 still remains an acceptable replacement for DOP."
CGMP Notes (Vol. 4, Number 4), December 1996.
太平洋仪器设备有限公司所代理的ATI生产的PAO油CAS号为: CAS # 68649-12-7,它是被FDA定义所接受.