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Rockville, MD, United States

Wang T.,University of Maryland, Baltimore | Ibrahim A.,University of Maryland, Baltimore | Potts A.R.,United States Pharmacopeial Convention | Hoag S.W.,University of Maryland, Baltimore
Acta Radiologica | Year: 2015

Using partial least square discriminate analysis (PLSDA), we studied the spectroscopic differences between the commonly used filler-binder microcrystalline cellulose (MCC) from five manufactures. These samples had subtle differences in the chemical and physical properties, which are often the cause of differences in excipient performance. Studying these differences allowed us to build and validate a model to classify five manufacturers of MCC using near-infrared (NIR) spectra. The sample training set includes 39 MCC samples collected from five manufactures with regions spanning the United States of America, Japan, Taiwan, Germany, and Brazil. The samples from individual manufacturers include diverse grades that differ in moisture content, particle size, and bulk density. Optimized pretreatment methods were identified as standard normal variate normalization, followed by Savitzky-Golay second derivative, mean centering, and orthogonal signal correction. The model was optimized with cross-validation and validated with an independent sample set comprising nine samples collected from those five manufacturers. The results showed that none of the samples in the independent validation set was misclassified. The score and loading plots revealed that the differences in content of oxidized cellulose group, water content and states, hydrogen bonding, and degree of polymerization of the MCC samples are responsible for the class differentiation. Permutation test demonstrated that the outcome of the PLSDA model was significantly different from that of the randomly generated model. The advantages and limitations of the method in this type of application were discussed. © 2015 Society for Applied Spectroscopy. Source


Hernandez-Cardoso A.,United States Pharmacopeial Convention
Pharmacopeial Forum | Year: 2014

Impurity measurements and control processes continue to evolve significantly as a result of scientific and technological innovations. These innovations, in combination with advancements in the field of toxicology, have contributed to the evolution of compendial standards for control of impurities in drug substances and drug products. As part of an ongoing monograph modernization initiative, U.S. Pharmacopeial Convention (USP) is updating general chapter Impurities in Drug Substances and Drug Products 〈1086〉 as it relates to the organic impurities tests for monographs in United States Pharmacopeia-National Formulary (USP-NF). In this issue of Pharmacopeial Forum, USP also proposes a new general chapter, Organic Impurities in Drug Substances and Drug Products 〈476〉. In late 2011, USP established the Impurities in Drug Products Expert Panel, with oversight from the Physical Analysis Expert Committee, to evaluate the current content of USP's impurities general chapters, 〈1086〉 and Ordinary Impurities 〈466〉, and General Notices and Requirements 5.60, Impurities and Foreign Substances. The Expert Panel was charged with making recommendations on updating the general chapters to align them with current standards and to help ensure the appropriate control of organic impurities in drug substances and drug products. The proposals of the Expert Panel are published in this same issue of Pharmacopeial Forum for public comments. The purpose of this Stimuli article is to (1) provide the rationale behind the revision of general chapter 〈1086〉 as it relates to organic impurities, (2) provide the rationale for the creation of general chapter 〈476〉, and (3) describe the scope of revision and the strategy for implementation. Source


Wu D.-T.,University of Macau | Li W.-Z.,Infinitus China Co. | Li W.-Z.,South China University of Technology | Chen J.,University of Macau | And 5 more authors.
Carbohydrate Polymers | Year: 2015

An evaluation system including colorimetric assay with iodine and potassium iodide, HPSEC-MALLS-RID analysis, GC-MS analysis, and saccharide mapping based on PACE analysis was proposed for the identification and discrimination of commercial product of Hericium erinaceus based on the chemical characters of polysaccharides in H. erinaceus fruiting body collected from different regions of China. The results showed that the molecular weights, the compositional monosaccharides and the glycosidic linkages of polysaccharides in H. erinaceus collected from different regions of China were similar, respectively. However, polysaccharides in the widely consumed product of H. erinaceus in China were significantly different from those of H. erinaceus fruiting body. The implications from these results were found to be beneficial to improve the quality control of polysaccharides from the H. erinaceus fruiting body, and suggest that the proposed evaluation system could be used as a routine approach for the quality control of polysaccharides in other edible and medicinal mushrooms. © 2015 Elsevier Ltd. Source


Trademark
United States Pharmacopeial Convention | Date: 2012-11-28

Newsletters and books concerning information on drug use and drug standards.


Usp

Trademark
United States Pharmacopeial Convention | Date: 2013-05-03

Chemical compounds and biological cell cultures for laboratory testing use with monographs containing standards for drugs, pharmaceutical excipients, dietary supplements and food ingredients. Newsletters and books containing scientific research information on standards for drugs, pharmaceutical excipients, dietary supplements and food ingredients. Providing online scientific research information on standards for drugs, pharmaceutical excipients, dietary supplements and food ingredients.

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