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This paper provides an overview of recent technological advances in the in situ control of pharmaceutical crystallization processes.
It also encompasses thin films, liquid crystals, sol-gel processing, control of pharmaceutical morphology, nanostructured materials, carbon nanotubes, surface chemistry, surface patterning, and many other areas of nanotechnology and surface science.
The real-time control of pharmaceutical manufacturing process is required to achieve the desired predefined Critical Quality Attributes (CQAs), satisfy precisely the tight regulatory constraints and high product quality expectations and thereby to improve product efficacy and patient safety.
The Process Analytical Technology PATT) initiative of the FDA is a reaction on the increasing discrepancy between current possibilities in process supervision and control of pharmaceutical production processes and its current application in industrial manufacturing processes.
In the quality control of pharmaceutical compounds and drug formulations made thereof ultraviolet (UV) spectrophotometry and spectroscopy play important roles as tools for the identification and quantitative determination of the active ingredient.
This label-free method is 100 times more sensitive than the mouse assay, potentially providing rapid read-out of small amounts of toxin for environmental surveillance and the quality control of pharmaceutical preparations.
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Gentiopicroside, swertiamarin and loganic acid were purchased from National Institute for Control of Pharmaceutical and Biological Products (Beijing, PR China) for the standard.
The standards reference samples of Ginsenosides Rb1, Rb2, Rc, Rd, Rg1, Re, Rf, AC, HA and MA were purchased from the National Institute for Control of Pharmaceutical and Biological Products (Beijing, China).
The regulation for the review committee of laboratory animal welfare and ethics and protocol for the review on laboratory animal welfare and ethics, National Institute for the Control of Pharmaceutical and Biological Products, were followed.
Corilagin standard substance (purity>99%) was offered by China National Institute for the Control of Pharmaceutical and Biological Products.
Triptolide (Chinese National Institute for the Control of Pharmaceutical and Biological Products, China), dissolved in dimethylsulfoxide (DMSO; Sigma, USA), was given by daily gastric gavage for 6 weeks.
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