Evaluation of physicochemical properties as supporting information on quality control of raw materials and veterinary pharmaceutical formulations

The purpose of this study was to evaluate physicochemical properties and dissolution studies of furosemide (FUR), hydrochlorothiazide (HCTZ) and nifedipine (NIF), low water solubility drugs, in raw materials and pharmaceutical formulations. Surface and physicochemical characterization techniques -scanning electronic microscopy (SEM), thermogravimetry (TG), X-ray diffraction (XRD) and infrared (IR) spectrometry- as well as physical and physicochemical tests on tablets and capsules were applied as supporting information on drug quality control. Simple, rapid, and efficient UV-Vis methods were developed and validated for the determination of FUR, HCTZ and NIF samples. SEM exhibited considerable differences in the crystal morphological structures. Among the drugs studied, except for furosemide, more than one polymorph was present in the samples. Drug release profiles were satisfactory for all products. FUR and HCTZ tablets exhibited similar dissolution profiles, with very rapid release to the pharmaceutical specialties (reference, similar and generic). For HCTZ tablets, the similar drug (f2= 48.74) is not equivalent to the reference drug. NIF capsules (reference and compounded) showed a release ≥80% of stated on product labels, in 10 minutes. The results obtained in this study suggest that the quality parameters and drug dissolution profiles may have been influenced by the morphology and size of the crystals, excipients, and technological processes.

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A Simple and Rapid HPLC Method for the Multidetermination of Enrofloxacin, Ciprofloxacin, and Oxytetracyclin in Raw Materials and Veterinary Pharmaceutical Formulations

Current Pharmaceutical Analysis ◽

10.2174/1573412913666170613091914 ◽

2018 ◽

Vol 14 (4) ◽

pp. 397-404

Author(s):

Sara da Silva Anacleto ◽

Leila Suleimara Teixeira ◽

Marcella Matos Cordeiro Borges ◽

Carolina Torres Moraes ◽

Warley de Souza Borges ◽

...

Keyword(s):

Raw Materials ◽

Pharmaceutical Formulations ◽

Hplc Method ◽

Veterinary Pharmaceutical

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A Validated Green HPTLC Method for Quantitative Determination of Dapoxetine Hydrochloride and Tadalafil in Bulk and Pharmaceutical Formulations

Journal of Chromatographic Science ◽

10.1093/chromsci/bmz115 ◽

2020 ◽

Vol 58 (4) ◽

pp. 303-308 ◽

Cited By ~ 3

Author(s):

Ibrahim A Naguib ◽

Maimana A Magdy ◽

Basma H Anwar ◽

Nessreen S Abdelhamid

Keyword(s):

Quality Control ◽

Mobile Phase ◽

High Performance ◽

Raw Materials ◽

Pharmaceutical Formulations ◽

Uv Detector ◽

Ich Guidelines ◽

Hptlc Method ◽

Dapoxetine Hydrochloride

Abstract Dapoxetine hydrochloride (DAP) and Tadalafil (TAD) were separated and determined quantitatively using a validated green high-performance thin layer chromatographic (HPTLC) method in their binary mixtures either as raw materials or in pharmaceutical formulations. The concentration ranges were 0.1–1.6 and 0.2–2.5 μg/band for dapoxetine and tadalafil, respectively, with accuracies of 98.93% ± 0.62 and 99.26% ± 1.39, respectively. Silica gel HPTLC F254 plates were used to carry out the separation. The mobile phase used was a mixture of ethanol–ethyl acetate (1:9 by volume), which is environmentally green and harmless. Densitometric scanning with UV detector was used to detect the separated peaks at 222 nm. ICH guidelines were followed to validate the suggested method, and the results prove that they can be used for regular analysis in quality control laboratories with compatible results.

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Development and Certification of Formononetin Reference Material for Quality Control of Functional Foods and Botanical Supplements

Current Analytical Chemistry ◽

10.2174/1573411014666180411152309 ◽

2019 ◽

Vol 15 (5) ◽

pp. 553-559

Author(s):

Ningbo Gong ◽

Baoxi Zhang ◽

Kun Hu ◽

Zhaolin Gao ◽

Guanhua Du ◽

...

Keyword(s):

Quality Control ◽

Reference Material ◽

Functional Foods ◽

Certified Reference Materials ◽

Coulometric Titration ◽

Pharmaceutical Formulations ◽

Uncertainty Estimation ◽

Expanded Uncertainty ◽

Scanning Calorimetry ◽

Botanical Supplements

Background: Formononetin is a common soy isoflavonoid that can be found abundantly in many natural plants. Previous studies have shown that formononetin possesses a variety of activities which can be applied for various medicinal purposes. Certified Reference Materials (CRMs) play a fundamental role in the food, traditional medicine and dietary supplement fields, and can be used for method validation, uncertainty estimation, as well as quality control. Methods: The purity of formononetin was determined by Differential Scanning Calorimetry (DSC), Coulometric Titration (CT) and Mass Balance (MB) methods. Results: This paper reports the sample preparation methodology, homogeneity and stability studies, value assignment, and uncertainty estimation of a new certified reference material of formononetin. DSC, CT and MB methods proved to be sufficiently reliable and accurate for the certification purpose. The purity of the formononetin CRM was therefore found to be 99.40% ± 0.24 % (k = 2) based on the combined value assignments and the expanded uncertainty. Conclusion: This CRM will be a reliable standard for the validation of the analytical methods and for quality assurance/quality control of formononetin and formononetin-related traditional herbs, food products, dietary supplements and pharmaceutical formulations.

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Encapsulation of Active Pharmaceutical Ingredients in Lipid Micro/Nanoparticles for Oral Administration by Spray-Cooling

Pharmaceutics ◽

10.3390/pharmaceutics13081186 ◽

2021 ◽

Vol 13 (8) ◽

pp. 1186

Author(s):

Carmen S. Favaro-Trindade ◽

Fernando E. de Matos Junior ◽

Paula K. Okuro ◽

João Dias-Ferreira ◽

Amanda Cano ◽

...

Keyword(s):

Oral Administration ◽

Raw Materials ◽

Low Cost ◽

Pharmaceutical Formulations ◽

Spray Cooling ◽

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients ◽

Taste And Odor ◽

Cooling Technology ◽

Simple Technology

Nanoencapsulation via spray cooling (also known as spray chilling and spray congealing) has been used with the aim to improve the functionality, solubility, and protection of drugs; as well as to reduce hygroscopicity; to modify taste and odor to enable oral administration; and many times to achieve a controlled release profile. It is a relatively simple technology, it does not require the use of low-cost solvents (mostly associated to toxicological risk), and it can be applied for lipid raw materials as excipients of oral pharmaceutical formulations. The objective of this work was to revise and discuss the advances of spray cooling technology, with a greater emphasis on the development of lipid micro/nanoparticles to the load of active pharmaceutical ingredients for oral administration.

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Physicochemical Properties of Handere Clays and Their Use as a Building Material

Journal of Chemistry ◽

10.1155/2015/374245 ◽

2015 ◽

Vol 2015 ◽

pp. 1-6 ◽

Cited By ~ 4

Author(s):

Yasin Erdoğan

Keyword(s):

Physicochemical Properties ◽

Building Materials ◽

Raw Materials ◽

Organic Matter Content ◽

Volcanic Glass ◽

Mineralogical Composition ◽

Matter Content ◽

Loss On Ignition ◽

X Ray Diffraction ◽

Clay Deposits

Handere clay deposits were discovered at Adana in Turkey. These clay units primarily consist of uncoloured claystone, pebbly sandstone, sandstone, siltstone, and mudstone marl and include gypsum lenses and clay levels of various thicknesses in places. The physicochemical properties of these clays have been investigated by different techniques including Scanning Electron and Elemental Analysis (SEM and EDS), mineralogical analyses, chemical and physical analyses, X-ray diffraction (XRD), thermogravimetric differential thermal analysis (TG-DTA), and Atterberg (Consistency) Limits Test. The mineralogical composition deduced from XRD is wide (smectite + palygorskite + illite ± feldspar ± chlorite ± quartz ± calcite ± serpentine) due to the high smectite contents (≈85%). SEM studies reveal that smectite minerals are composed of irregular platy leaves and show honeycomb pattern in the form of wavy leaves in places. The leaves presenting an array with surface edge contact are usually concentrated in the dissolution voids and fractures of volcanic glass. Organic matter content and loss on ignition analysis of raw materials are good for all the studied samples. In summary, Handere clays can be used as building materials in bricks, roof tiles, and cement and as a binder.

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QUALITY CONTROL OF PHARMACEUTICAL FORMULATIONS OF NEUROLEPTIC DRUGS BY CAPILLARY ZONE ELECTROPHORESIS

Journal of Liquid Chromatography &amp Related Technologies ◽

10.1081/jlc-100101433 ◽

2000 ◽

Vol 23 (1) ◽

pp. 25-34 ◽

Cited By ~ 28

Author(s):

V. Pucci ◽

M. A. Raggi ◽

E. Kenndler

Keyword(s):

Quality Control ◽

Capillary Zone Electrophoresis ◽

Pharmaceutical Formulations ◽

Neuroleptic Drugs ◽

Zone Electrophoresis ◽

Capillary Zone

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CERTIFICATION OF VEGETABLE OILS AND QUALITY CONTROL IN THE TECHNOLOGICAL PROCESS OF PRODUCTION

Technical science and innovation ◽

10.51346/tstu-01.19.4.-77-0038 ◽

2019 ◽

Vol 2019 (4) ◽

pp. 119-126

Author(s):

CH Bekmurotov ◽

Keyword(s):

Quality Control ◽

Technological Process ◽

Vegetable Oils ◽

Raw Materials ◽

Cottonseed Oil ◽

Product Classification ◽

Cotton Seeds ◽

The Cost

The article reviewed the certification and quality control of the technological process for the production of vegetable oil. There is a procedure for packaging, quality control of products, determination of quality indicators and quality control of finished products. The procedure for using refined cottonseed oil and its varieties, the requirements for placement and storage of vegetable oils, as specified in the regulatory documents, the quality control of vegetable oils and other solutions for cottonseed oil are provided. The gas analyzer shows a solution for measuring the amount of solution by painting the tubes of a mixture of gas and air in oil. Detailed information on the production of vegetable oils, the cost of raw materials, the level of fat content of cotton seeds and the methods used to produce oil from cotton seeds. Methods for certification of vegetable oils, types of quality control, methods of testing and quality determination are presented. It was shown that the procedure for refined production of cottonseed oils and their types, as well as the state of the product classification of products based on the method of producing vegetable oils for consumer purposes, analysis of the sequence of refined oils and refining processes.

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Development of the technique for quality control of 1,3-bis(3,4-dicyanophenoxy)benzene by HPLC

Тонкие химические технологии ◽

10.32362/2410-6593-2021-16-1-88-98 ◽

2021 ◽

Vol 16 (1) ◽

pp. 88-98

Author(s):

Z. N. Shchekoldina ◽

A. A. Bogolyubov ◽

A. Yu. Zakharov ◽

B. A. Bulgakov ◽

A. V. Babkin ◽

...

Keyword(s):

Quality Control ◽

High Performance ◽

Raw Materials ◽

Reaction Times ◽

Kinetic Studies ◽

Reversed Phase ◽

Quantitative Chemical Analysis ◽

Practical Applications ◽

Good Convergence ◽

Quantitative Hplc Analysis

Objectives. Determination of target products and byproducts is necessary for the quality control of phthalonitrile monomer synthesis as well as production scaling and performing related kinetic studies. High-performance liquid chromatography (HPLC) is a simple and affordable method for quantitative chemical analysis, which also verifies the quality of raw materials. The objective of this study was to develop an HPLC technique for determining the composition of the reaction mixture in the synthesis of 1,3-bis(3,4-dicyanophenoxy)benzene (DPB).Methods. Reversed-phase HPLC was used to quantitatively analyze the reaction mixture.Results. A simple and rapid method for the quantitative HPLC analysis of phthalonitrile monomers and their mixtures with reagents was developed. Reaction times and the accumulation of byproducts were also studied.Conclusions. The successful performance of the developed technique allows us to recommend it for practical applications. The results obtained for reactors of different sizes have good convergence, and DPB synthesis was successfully scaled up to intermediate scale equipment.

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PENERAPAN STATISTICAL QUALITY CONTROL (SQC) PADA PENGENDALIAN MUTU MINYAK TELON (STUDI KASUS DI PT.X)

AGROINTEK ◽

10.21107/agrointek.v13i1.4920 ◽

2019 ◽

Vol 13 (1) ◽

pp. 72

Author(s):

Andan Linggar Rucitra ◽

S Fadiah

Keyword(s):

Quality Control ◽

Raw Materials ◽

Control Process ◽

Statistical Quality Control ◽

Statistical Quality ◽

Quality Control Process ◽

Fishbone Diagram ◽

Potential Factor ◽

Measurement Of Success

Telon oil is one of the traditional medicine in the form of liquid preparations that serves to provide a sense of warmth to the wearer. PT.X is one of the companies that produce telon oil. To maintain the quality of telon oil from PT.X product, required overall quality control that is starting from the quality control of raw materials, quality control process to the quality control of the final product. The purpose of this research is to know the application of Statistical Quality Control (SQC) in controlling the quality of telon oil in PT X. Final product quality become one of the measurement of success of a process, so it needs a good quality control. SQC method used in this research is Pareto Diagram and Cause and Effect Diagram. Pareto diagram is a bar graph that show the problem based on the order of the number of occurrences of the most number of problems until the least happened. A causal diagram is often called a fishbone diagram, a tool for identifying potential causes of an effect or problem. The result of applying the method indicates that 80% defect is caused by unsuitable volume and on the incompatibility of Expired Date (ED) code. The damage is caused by several factors namely the method, labor, and machine while the most potential factor is the volume conformity to reduce the number of defect products.

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