New stability indicating chromatographic methods have been developed for estimation of Assay and Impurities of Docetaxel in Docetaxel injection for evaluation of pharmaceutical quality. With this method, the process related impurities and degradants are well separated from the peaks due to placebo. The relative retention times and relative response factors of the known impurities have been esta...

We simulate the formation of experimentally observed trapezoidal hillocks on etched Si(110) surfaces, describing their generic geometrical shape and analyzing the relative stability and/or reactivity of the key surface sites. In our model, the hillocks are stabilized by Cu impurities in the etchant adsorbing on the surface and acting as pinning agents. A model of random adsorptions will not res...

impurities of drug substances may produce some side effects in patient. diclofenac na is a member of non-steroidal anti inflammatory drugs (nsaids) family, which is routinely used by patients for the treatment of rheumatoid arthritis and various pains. to develop a method for the determination of synthetic precursors which could be remained as impurities in raw drug materials, na diclofenac pow...

paracetamol that is known as acetaminophen have the most consume as an analgesic and antipyreticdrug in the world. that is formulated in single compound or mixture at many forms such astablets, syrups, suspensions and drops. the last form is intravenous injections. paracetamol derivedfrom 4-minophenol which is synthesized by acylated the p-acetaminophenol and acetic anhydride.4-aminophenol is t...

Thorough knowledge and control of impurities is an expectation for the registration of pharmaceuticals. Actual and potential impurity investigations are phased during drug development to acquire the appropriate information necessary to ensure drug safety from the standpoint of patient exposure to impurities. Regulatory expectations and common practices for the timing of impurity investigations ...

While the use of pharmaceuticals is always a balance of risks and benefits, the same is not true for impurities in pharmaceuticals; impurities convey only risk. A number of international guidelines and regional guidances instruct drug developers and regulatory agencies on how to evaluate and control impurities in drug substances and drug products. While impurities should always be reduced to th...

We demonstrate theoretically that most of the observed transport properties of graphene sheets at zero magnetic field can be explained by scattering from charged impurities. We find that, contrary to common perception, these properties are not universal but depend on the concentration of charged impurities n(imp). For dirty samples (250 x 10(10) cm(-2) < n(imp) < 400 x 10(10) cm(-2)), the value...

in this paper a fast and novel stability-indicating ultra fast lc method for separation and estimation of impurities in clopidogrel and aspirin in their combined tablet dosage form and omeprazole was developed. the separation of usp related substances of clopidogrel (a, b and c), aspirin (d), omeprazole (a, b and c) and few other unknown impurities was detected by using ultra fast liquid chroma...

Key Challenges of Impurity Profiling Workflow  Identification and quantification of trace-level impurities in drug substances and drug products  Laborious workflows for accurate characterization and confirmation of related impurities and other degradants which are present at or below 0.1%  Manual and time consuming structure elucidation process for drug related impurities or unknown impuriti...