Form Of Raw Materials Research Articles

Development of a simple, rapid and validated square wave voltametric method for determination of promethazine in raw material and pharmaceutical formulation using DNA modified multiwall carbon nanotube paste electrode

Abstract A simple voltammetric method based on a composite biosensor MWCN/SiO 2 /Al 2 O 3 /Nb 2 O 5 /DNA (MWCN/SiAlNb/DNA) was developed and validated for the determination of promethazine (PHZ) in raw material and pharmaceutical formulation. The best results were obtained by using square wave voltammetry under measurements at 0.30 mol L −1 phosphate buffer pH 7.0 and DNA immobilization onto SiAlNb surface using 0.8 mg mL −1 concentration. Validation parameters such as: selectivity, linearity, precision, accuracy, and stability presented results within the acceptable range. The sensitivity of sensor was found to be 0.210 μA μmol −1 L. Therefore, the developed method was successfully applied for the PHZ determination in real samples of pharmaceutical formulations and can be used for routine quality control analysis of bulk pharmaceutical and pharmaceutical formulations containing PHZ.

Experimental Investigation on Autoclaved Aerated Concrete Using Palladium-Platinum Tailings

In this paper, the low-silicon palladium-platinum tailing is used to produce autoclaved aerated concrete. The influences of water binder ratio, palladium-platinum tailing content, lime content and conditioning agents on the compressive strength of the autoclaved aerated concrete are investigated. Optimal raw material formulation and procedure are determined for the autoclaved aerated concrete. The compressive strength and frost resistance of autoclaved aerated concrete made by the optimal raw material formulation and procedure meet with the requirements of autoclaved aerated concretes of B06 grade, and its thermal conductivity, drying shrinkage reach the requirements of the relevant national standards of China.

Development of porous powder printed high density polyethylene for personalized bone implants

In this study, three dimensional printing (3DP) coupled with heat treatment was investigated as a new technique for fabrication of bone implant. An influence of using different content of polyethylene (0.60–0.80 w/w) in the raw material formulation upon the microstructure, density, porosity, shrinkage and tensile properties of porous high density polyethylene structure was investigated. It was found that the relationship between structure and properties was strongly influenced by the interplay between polyethylene content and heat treatment steps. This heat treatment process could increase the properties of porous high density polyethylene significantly over the as-fabricated 3DP sample without destroying porous structure. Porous high density polyethylene bodies having a porosity ranging from 22.3–49.7% and pore diameters of 132.6–136.2 microns with tensile strength up to approximately 4 MPa which was comparable to commercial product could be successfully prepared in this study. Biocompatibility of selected formulation (0.70 w/w) indicated that the prepared structure was not toxic and could support the osteoblast cell proliferation.

FAST AND SENSITIVE NEW HPLC-UV METHOD FOR DETERMINATION OF OMEPRAZOLE AND MAJOR RELATED SUBSTANCES IN PHARMACEUTICAL FORMULATION

A simple, fast, and sensitive HPLC method with UV detection has been developed for the quantitation of omeprazole (OMZ) and major related substances in raw material and pharmaceutical formulation (paste) using a column of reduced length (50 mm) and diameter (2.1 mm) packed with hybrid particles. Chromatographic conditions were: 25°C, 1 µl injection volume, and UV detection at WV of 280 nm. The flow rate was 0.3 mL/min using methanol-phosphate buffer (pH 7.6) (40:60) as the mobile phase. Chromatographic purity was also determined with the same chromatographic conditions. The method was validated according to international guidelines (ICH guidelines) for specificity, linearity, LOD, LOQ, precision, accuracy, and robustness. The HPLC-UV method was found to be suitable for the quality control and stability studies of OMZ in a pharmaceutical formulation.

Impacto do tipo de misturador e do tempo de mistura nas propriedades de argamassas industrializadas

Resumo Argamassas industrializadas anidras usualmente empregam aditivos em suas formulações, sendo muito comum o uso de incorporadores de ar. Apesar do rigor da produção deste material em ambiente fabril, variações nas condições de preparo em obra podem afetar o teor de ar no revestimento. Usualmente, as argamassas são processadas manualmente em obras ou com o auxílio de equipamentos de mistura. Dessa forma, neste trabalho foi avaliado o impacto do tipo de equipamento e do tempo de mistura na incorporação de ar de argamassas industrializadas e o efeito nas propriedades após o endurecimento. Os resultados indicam que a incorporação de ar decorre da adequação entre o equipamento de mistura e a formulação da argamassa, sendo identificada diferença de sensibilidade das argamassas ao tipo de equipamento. Tal fato permite inferir que a alternativa para reduzir a variabilidade do teor de ar em obra depende do desenvolvimento de formulações com mínima sensibilidade ao processo de mistura.

Simple, Highly Sensitive Micro HPLC Method for the Determination of Coenzyme Q10 and its Major Related Substances

A simiple, rapid, and highly sensitive fast microbore HPLC method with UV detection has been developed for the quantitation of coenzyme Q10 (Co-Q10) and related substances in raw material, pharmaceutical, and cosmetic formulations using a column with hybrid particles. Chromatographic conditions were: 30ºC column temperature, 1 µL injection volume at 275 nm. The Co-Q10 analysis was performed within 2.5 minutes with a flow rate of 0.3 mL/min. with a mobile phase consisted of 100% methanol, and the related substances were separated with a gradient elution based on methanol-water. The developed method was validated for selectivity, linearity, precision, accuracy, and robutness. The method was found to be suitable for the quality control of Co-Q10 in pharmaceutical and cosmetic products, as well as the stability indicating studies.

Biological potency evaluation and physicochemical characterization of unfractionated heparins

Unfractionated heparins are used clinically as anticoagulants. The biological potency of thirteen samples of raw material and pharmaceutical formulations were assessed utilizing the 5th International Standard of heparin using the sheep plasma coagulation inhibition assay, activated partial thromboplastin time, anti-factor Xa assay, and anti-factor IIa assay, resulting in mean potencies of 101.15%, 96.15%, 98.15% and 99.37%, respectively. The samples were also evaluated by the protamine neutralization test giving results within the range of 92 - 138 IU/mg. The anti-factor IIa assay was performed showing reproducibility and significant correlation with the pharmacopoeial assays, thus demonstrating it to be a feasible alternative to the sheep plasma coagulation inhibition assay. Moreover, an analysis by nuclear magnetic resonance and capillary electrophoresis showed some peaks attributable to oversulfated chondroitin sulfate. The results show that batch-to-batch variations and the quality of samples contributed to improvements in the quality control of pharmaceutical products and to assure the safe use and clinical efficacy of this biological medicine.

Spectrophotometric Determination of Risedronate in Pharmaceutical Formulations via Complex Formation with Cu (II) Ions: Application to Content Uniformity Testing

A simple, sensitive, rapid and accurate spectrophotometric method was developed for the determination of risedronate, a bisphosphonate drug important for the treatment of a variety of bone diseases, in raw material and pharmaceutical formulations. The proposed method is based on complex formation between risedronate and Cu (II) ions in acetate buffer of pH5.5. The optimum conditions for this reaction were ascertained and a spectrophotometric method was developed for the determination of risedronate in concentration range of 2-40 µg/mL with detection limit of 0.03 µg/mL (9.51 × 10-8 mol/L). The molar absorbtivity was 8.00 × 103 l/mol/cm. The method was successfully applied for the determination of risedronate in tablet dosage form with mean percentage recovery of 101.04 ± 0.32. The results obtained were favorably compared with those obtained by the comparison method. Furthermore, the proposed method was applied for content uniformity testing of risedronate tablets.

Influence of calcium phosphate on rheological properties of sanitaryware slip

The aim of this work is to study the influence of calcium phosphate on sanitaryware suspension viscoelasticity. The specific interest was given to use of waste calcium phosphate instead of feldspar in a sanitaryware slip: the goal is to set up a new formulation of raw materials with the same rheological properties and related casting parameters of the traditional one. Above all, two suspensions parameters were studied: the calcium phosphate concentration and the aging effects. The most appropriate calcium phosphate concentration and aging time were found.

Bioengineering for pollution prevention through development of biobased energy and materials state of the science report

Industrial BiotechnologyVol. 3, No. 3 Industry ReportBioengineering for pollution prevention through development of biobased energy and materials state of the science reportDianne Ahmann and John R. DorganDianne AhmannSearch for more papers by this author and John R. DorganSearch for more papers by this authorPublished Online:7 Nov 2007https://doi.org/10.1089/ind.2007.3.218AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail FiguresReferencesRelatedDetailsCited byThe development process of plant-based meat alternatives: raw material formulations and processing strategiesFood Research International, Vol. 3Role of Nanoparticles in Biodegradation and Their Importance in Environmental and Biomedical ApplicationsJournal of Nanomaterials, Vol. 2022Metal oxide nanoparticles for environmental remediationThe development history and recent updates on soy protein-based meat alternativesTrends in Food Science & Technology, Vol. 109BioentrepreneurshipInjection-Molded Parts of Partially Biobased Polyamide 610 and Biobased Halloysite Nanotubes6 July 2020 | Polymers, Vol. 12, No. 7Development of Efficient Composites via Renewable, Recyclable, and Degradable Additives4 December 2019Evaluation of promoter sequences for the secretory production of a Clostridium thermocellum cellulase in Paenibacillus polymyxa26 September 2018 | Applied Microbiology and Biotechnology, Vol. 102, No. 23Rheological properties and microstructure of soy protein isolate /κ-carrageenan gels under high-speed shear treatmentJournal of Food Engineering, Vol. 236Biorenewable blends of polyamide‐4,10 and polyamide‐6,105 April 2016 | Journal of Applied Polymer Science, Vol. 133, No. 45Intellectual Property and Biofuels: The Energy Crisis, Food Security, and Climate ChangeSSRN Electronic JournalOptimal conditions of different flocculation methods for harvesting Scenedesmus sp. cultivated in an open-pond systemBioresource Technology, Vol. 133Next-generation biopolymers: Advanced functionality and improved sustainability16 September 2011 | MRS Bulletin, Vol. 36, No. 9Patenting Trends and Innovation in Industrial BiotechnologySSRN Electronic Journal Volume 3Issue 3Oct 2007 InformationCopyright 2007, Mary Ann Liebert, Inc.To cite this article:Dianne Ahmann and John R. Dorgan.Bioengineering for pollution prevention through development of biobased energy and materials state of the science report.Industrial Biotechnology.Oct 2007.218-259.http://doi.org/10.1089/ind.2007.3.218Published in Volume: 3 Issue 3: November 7, 2007PDF download

Fibrous Sepiolite Use As An Asbestos Substitute: Analytical Basics

Abstract Open trade policies have influenced trends in global economic growth. Though difficult to account for all of the effects of this trend, a higher standard of living for previously distressed workers is measurable. This is in part due to acess to previously unavailable technologies. The effects of global economic growth extend further. In many countries, consumers enjoy unparalleled selection of high quality, low cost goods. The environmental impact of global growth is being studied in many ways. One area of study involves analysis and monitoring of product raw materials that many times are not in compliance with environmental regulations of the end user country. Raw material procurement and formulation by manufacturers presents a challenge to the environmental microscopist on several levels. The industrial use of sepiolite and some light microscopy basics of sepiolite is discussed here. Subsequent papers will explore this issue in greater detail as it relates to fibrous mineral analytical choices and techniques available to the environmental microscopist.

Development and Validation of Three Stability-Indicating Methods for Determination of Bisacodyl in Pure Form and Pharmaceutical Preparations

Three new, simple, sensitive, and accurate stability-indicating methods were developed for quantitative determination of bisacodyl in the presence of its degradation products, monoacetyl bisacodyl (I) and desacetyl bisacodyl (II), in enteric coated tablets, suppositories, and raw material. The first is a spectrodensitometric method in which the drug is separated from I and II on silica gel plates using chloroform-acetone (9 + 1, v/v) as the mobile phase with ultraviolet detection of the separated bands at 223 nm over a concentration range of 0.2-1.4 microg/band for bisacodyl with mean recovery 100.35 +/- 1.923%. The second method is fourth derivative D4 spectrophotometry, which allows determination of bisacodyl in the presence of its degradation products in raw material at 223 nm using acetonitrile as the solvent with adherence to Beer's law over the concentration range 2-18 microg/mL with mean recovery 99.77+/-1.056%. In the third method, the spectrophotometric data of bisacodyl, I, and II using absolute ethanol as solvent were processed by 3 chemometric techniques: classical least-squares, principal component regression, and partial least-squares. A training set consisting of 15 mixtures containing different ratios of bisacodyl, I, and II was used for construction of the 3 models. A validation set consisting of 6 mixtures was used to validate the prediction ability of the suggested models. The 3 chemometric methods were applicable over a concentration range between 2-14microg/mL for bisacodyl with mean recovery of 99.97+/-0.865, 100.01 +/- 0.749, and 99.97 +/- 0.616% for the 3 models, respectively. The proposed methods were checked using laboratory-prepared mixtures and were successfully applied to the analysis of raw material and pharmaceutical formulations containing bisacodyl, except for the second method that applies only for raw material. The validity of the suggested procedures was further assessed by applying the standard addition technique; the recoveries obtained were in accordance with those given by the reference method.

C 18 columns for the simultaneous determination of oxytetracycline and its related substances by reversed-phase high performance liquid chromatography and UV detection

Simultaneous determination of oxytetracycline, 4-epioxytetracycline, α-apooxytetracycline, tetracycline and β-apooxytetracycline on C 18 columns has been accomplished using a high performance liquid chromatographic method with UV detection. Separation was achieved on a Hypersil BDS RP-C 18 column (250 mm × 4.6 mm) and on a Waters C 18 Symmetry column (150 mm × 3.9 mm), 5 μm particle size each. These columns were equilibrated with mobile phases consisted of methanol–acetonitrile–0.1 M phosphate buffer pH 8.0 (12.5:12.5:75, v/v/v) and (15:15:70, v/v/v), respectively. The flow rate was 1.0 ml/min and the total elution time was 15 and 5 min, respectively. Both methods were applied to oxytetracycline raw material, human and veterinary formulations, where the excipients did not interfere. External standard calibration curves were linear for 4-epioxytetracycline, oxytetracycline, α-apooxytetracycline, tetracycline and β-apooxytetracycline in the concentration range of 0.27–200 μM, 0.05–200 μM, 0.03–200 μM, 0.35–200 μM and 0.20–200 μM on column A and 0.08–200 μM, 0.15–200 μM, 0.09–200 μM, 0.25–200 μM and 0.47–200 μM on column B, respectively. Day-to-day relative standard deviation of the determination for every component was less than 3%. Concerning the first column, limits of detection and quantification of the above compounds were in the concentration ranges of 10–106 nM and 30–352 nM, respectively, whereas on the second column these ranges became 27–144 nM and 81–475 nM, respectively. Recovery of the separated compounds was 95–105%.

Effect of Söderberg Smelting Technology, Anode Paste Composition, and Work Shift on the Relationship Between Benzo[a]pyrene and Individual Polycyclic Aromatic Hydrocarbons

ABSTRACT This follow-up study of Farant and Gariepy study investigates the relationship between benzo[a]pyrene (B[a]P) and other polycyclic aromatic hydrocarbons (PAHs) found in coal tar pitch volatiles in two types of Söderberg aluminum smelters—horizontal and vertical stud. The study confirms the strong relationships between B[a]P and total PAHs, and that B[a]P was a good indicator for other PAHs in this industry. The PAH profiles were consistent within each smelter, but the smelter technology used and the changes in the raw material formulation resulted in significantly different profiles. B[a]P toxic equivalency factors for emitted PAH mixtures were greater in the horizontal stud smelter than in the vertical stud smelter. Overall, this study illustrates the potential usefulness of B[a]P relative abundance ratios to simplify exposure assessment in the workplace and reduce associated costs.

Development of a reversed-phase thin-layer chromatographic method for artemisinin and its derivatives.

In this study a clear separation between seven analogues of artemisinin on thin-layer chromatography (TLC) is presented. The developed TLC method is carried out on a RP-C18 thin-layer plate using acetonitrile-water (50:25 v/v) as the mobile phase. Spots are visualized by derivatization with an acidified 4-methoxybenzaldehyde reagent in methanol-water. This method allows the separation of a diverse group of compounds that have versatile hydrophilic/lipophilic characteristics; namely artemisinin, artesunate (AS), artelinic acid (AL), arteether (AE), both isomers of artemether (AM) (alpha and beta), dihydroartemisinin, and desoxyartemisinin. Separation of some degradation products and impurities, down to 2%, allows quality control and stability investigation of all actives in raw material and pharmaceutical formulations. The method is further developed via densitometric measurement for quantitative determination purposes for AL and AS. The derivatization technique is evaluated, showing good stability and reproducibility of the coloring process. Percent relative standard deviation values are less than 5% for replicates, and linearity is obtained in the range of 0.5 to 8 microg. A comparative study with high-performance liquid chromatography (HPLC) on a C18 column, applying the same mobile phase, proves the suitability of the TLC method, in which almost all presented analytes are separated from each other. In contrast, HPLC requires at least a 20-min analysis to chromatograph all of the compounds and only betaAM and AE are clearly separated from each other and from the other compounds.

Development and Validation Method for Silica Determination by Spectrophotometry in Some Herbs and Pharmaceutical Formulations

ABSTRACT A spectrophotometric method for determination of silica in herbs and herbal pharmaceutical products has been developed and validated. The method showed excellent accuracy and precision with S.D. 1.67 and RSD 1.72%, 2.75%, respectively. The established linearity range was 0.05–0.5 μg/mL(r2 > 0.99974). The recovery of silica from spiked placebo was > 95% over the linear range. The method has been successfully used in the analysis of silica in raw material and herbal pharmaceutical formulations. This validated method proved to be rapid and less costly.

Validated chiral high-performance liquid chromatographic method for the determination of trans-(−)-paroxetine and its enantiomer in bulk and pharmaceutical formulations

A stereospecific high-performance liquid chromatography method for the determination of trans-(−)-paroxetine and its enantiomer in bulk raw material and pharmaceutical formulations was developed and validated. The enantiomeric separation was achieved, without any derivatization, on a carbamate derivative-based column (Chiralpak AD). The effect of the organic modifiers, 2-propanol and ethanol, in the mobile phases was optimised to obtain enantiomeric separation. Limits of detection and quantitation of 2 and 6 ng, respectively, were obtained for both of the enantiomers. The linearity was established in the range of 5–41 μg for trans-(−)-paroxetine and in the range of 10–160 ng for trans-(+)-paroxetine. The accuracy of the method was 102.3% (mean value) for trans-(−)-paroxetine and 99.9% (mean value) for trans-(+)-paroxetine. For the precision (repeatability), a relative standard deviation value of 1.5% (mean value) for trans-(−)-paroxetine and of 2.1% (mean value) for trans-(+)-paroxetine was found. The method is capable of determining a minimum limit of 0.2% of trans-(+)-isomer in commercial samples.

High Performance Liquid Chromatographic Assay for Isosorbide 5-Mononitrate and Impurities of Inorganic Nitrates in Pharmaceuticals

Abstract A simple and reliable high performance liquid chromatographic (HPLC) method for the quantification of isosorbide 5- mononitrate and inorganic nitrate impurity in raw material and dosage formulations has been developed and validated. The procedure which simultaneously resolves active organic nitrates: isosorbide 5-mononitrate, isosorbide 2-mononitrate and isosorbide 2.5-dinitrate, and main impurities (including related nitrate and acetate esters), may be used as a control of purity of raw material and dosage forms.

Liquid Chromatographic Method for Selegiline Hydrochloride and Related Compounds in Raw Materials and Tablets

Abstract A liquid chromatographic method has been developed for determination of selegiline hydrochloride and related substances in drug raw material and tablet formulations. The method resolves 3 known related compounds from the drug with a limit of quantitation of less than 0.05%. Drug raw material and tablet samples contained ca 0.2 and 0.6% impurities, respectively. These included some related compounds, the identities of which were confirmed by gas chromatography with a Fourier transform Infrared detector.

Determination of Hydrazine in Pharmaceuticals IV: Hydrazine and Benzylhydrazine in lsocarboxazid

A GC procedure for the simultaneous determination of hydrazine and benzylhydrazine in isocarboxazid raw material and tablet formulations has been developed. The method is based on the reaction of benzoyltrifluoroacetone with hydrazine and benzylhydrazine to form the corresponding pyrazole derivatives. The minimum detectable amounts of hydrazine and benzylhydrazine in isocarboxazid are 0.002 and 0.02%, respectively.