Results of all validation parameter were within the limit as per ICH guideline.Prabhat DessaiManasi Prabhu Dessai
[199], and there are some parameters to reflect the colloidal stability, like the second virial coefficient (B22) or protein interaction parameter (kD) [200], the colloidal stability of protein drug formulation is as complicated as conformational stability and still a thorny issue in protein-...
Degradation conditions Degradation product Forced degradation Stability indicating method Stress testing 1. Introduction Chemical stability of pharmaceutical molecules is a matter of great concern as it affects the safety and efficacy of the drug product. The FDA and ICH guidances state the requirement of...
present work was to develop an economic, precise, accurate, specific, and stability-indicating HPTLC method using densitometric detection for the determination of emtricitabine in the presence of its degradation products, either in bulk form or in pharmaceutical dosage form as per ICH guidelines [15,...
For 16 nm repeat maps, the aligned parameter was transferred back to M for multi-particle refinement, and the resolution reaches the Nyquist limit. Then the sub-tomograms corresponding to A- and B-tubule were reconstructed in box size of 1283 voxels with 3.52 Å pixel size by M, ...
A new stability-indicating high-performance liquid chromatographic method of analysis of capecitabine in pharmaceutical dosage form was developed and validated. The solvent system consisted of methanol: water (60:40% v/v). The retention time of capecitab
The term\(dW_t\)is the increment of a Wiener process that is independently drawn for each degree of freedom, and\(\sigma ^2\)is variance. Parameter values forrandbare the same as those from Fig.2. The volume contraction rate is similar to that in the deterministic Lorenz but with an ...
in use stability专题研究 In use stability专题研究 Zhulikou431 内部培训 2012 中国
ParameterOxidative Degradate Empty CellAcid Degradate Empty CellFAV Empty CellAlkali DegradateReference value [20] Selectivity (α) a 2.3 1.2 1.4 >1.0 Resolution (Rs) b 9.6 2.8 4.1 Rs > 1.5 Tailing factor (T) 1 1 1 1 T≤ 2 Column efficiency (N) 2003 4994 2698 3337 N > 2000 Height ...
LAL test resulted negative for the same samples, indicating the absence of pyrogens (<0.125 EU/mL, data not shown). These results indicate that cetuximab and panitumumab vial leftovers, as well as their preparations, can be maintained under sterile conditions for extended periods if vial handling...