在H3-VD-50303-RVP 01版盐酸多柔比星工艺再验证方案的产

The product uniformity inspection standard of the H3-VD-50303-RVP 01 version of the doxorubicin hydrochloride process revalidation program did not clearly stipulate the RSD limit, and the uniformity of the 1050-C200102 batch of doxorubicin hydrochloride finished products-1/ -2/-3 During automatic batch integration, due to the difference in the rising amplitude of impurity peaks with retention time around 9min in the uniformity-1 and uniformity-2/3 spectra, the system uses two different integration methods for integration and analysis Without following the basic principles of scientific, reasonable and accurate integration, the staff manually intervened the impurity peaks with retention time of about 9 minutes in the homogeneity-2/3 spectrum.

The RSD limit is not specified in the product uniformity inspection standard of H3-VD-50303-RVP 01 version of the hydrochloric acid multi-soft star process re-verification scheme, and 1050-C200102 batch hydrochloric acid multi-softer star finished product uniformity-1/-2/-3 automatic batch processing integral Because of the difference between the increase of impurity peak with retention time of about 9min in the homogeneity-1 and homogeneity-2/3 map, the system uses two different integral methods for integration, and the analyst intervenes manually on the impurity peak with retention time of about 9min in the homogeneity-2/3 map without following the basic principles of integral science, rationality and accurateness.

In h3-vd-50303-rvp The limit of RSD was not specified in the product homogeneity standard of doxorubicin hydrochloride process revalidation scheme (version 01). During the automatic batch processing integration of 1050-c200102 batches of doxorubicin hydrochloride finished product homogeneity-1 / - 2 / - 3, two different integration methods were used due to the difference of impurity peak rising amplitude with retention time of about 9min between homogeneity-1 and homogeneity-2 / 3 Without following the basic principles of scientific, reasonable and accurate integration, the analyst manually intervened the impurity peaks with a retention time of about 9 min in the homogeneity-2 / 3 spectrum.<br>