scholarly journals Differentiating Curculigo Orchioides Rhizoma and Curculigo glabrescens Rhizoma by a Unique New Compound

2020 ◽  
Author(s):  
Yu-shi Liu ◽  
Yi-ping Guo ◽  
Juan-ru Liu ◽  
Xiao-hong Bao ◽  
Juan Zhou ◽  
...  
Keyword(s):  
Quality Control ◽  
Clinical Practice ◽  
Genetic Similarity ◽  
Market Research ◽  
Hplc Method ◽  
Curculigo Orchioides ◽  
Correct Application ◽  
First Time ◽  
Characteristic Component ◽  
High Genetic Similarity

Abstract Background: Market research found that Curculigo glabrescens Rhizoma (CGR) is the major counterfeit of the Curculigo orchioides Rhizoma (COR). C. orchioides Gaertn and C. glabrescens (Ridl.) Merr. belong to the same family and genus, with close plant relationships and high genetic similarity, and rhizomes of the herbs part have less distinguished characteristics, which make the identification difficult.Methods: In order to distinguish COR from CGR more accurately and conveniently, HPLC method was used to establish a characteristic chromatogram of the two herbs, and a unique component in CGR was discovered for first time. Based on that, the characteristic component was systematically separated and purified.Results: The unique component was a new neolignans and named glabrescenin, which could specifically distinguish COR from CGR. The HPLC method we used could establish a characteristic chromatography of CGR.Conclusion: This study was conducive to the quality control of Curculigo, and could promote the correct application of genuine COR in clinical practice.

scholarly journals Identification, Synthesis, Characterization and Quality Control Strategy of New Process-Related Impurities in Fosphenytoin Sodium

2020 ◽  
Vol 32 (8) ◽  
pp. 1881-1885
Author(s):  
Sathiyanarayanan Singaram ◽  
Venkatesan Chidambaram Subramanian ◽  
Senthamaraikannan Kabilan ◽  
Dandu Bhaskara Suresh Raju
Keyword(s):  
Quality Control ◽  
Quality Standard ◽  
Hplc Method ◽  
Pharmaceutical Manufacturing ◽  
Spectral Techniques ◽  
Related Impurities ◽  
New Process ◽  
Control Procedures ◽  
Quality Control Strategy ◽  
First Time

Fosphenytoin sodium is a water dissolvable phenytoin prodrug that is directed intravenously to convey phenytoin, conceivably more securely than intravenous phenytoin. It is most ordinarily utilized in the intense treatment of convulsive status epileptics. The examination of the procedure-related contaminants will not help exclusively to advance the process parameters yet additionally to create sensible analytical methods and set the quality standard for a quality control system in pharmaceutical manufacturing. During the production of fosphenytoin sodium, all the process-related impurities are controlled in every stage and three degradation impurities are managed in the final API as per USP monograph. Besides, five unknown and one known contaminants were detected by HPLC method. All these impurities were identified, synthesized, isolated and characterized by IR, 1D-NMR (1H, 13C, DEPT) and HRMS spectral techniques. The mechanism of the formed impurities is examined for the first time. Quality control procedures to manage these impurities were developed to acquire the mass medication of ICH grade quality.

Development of an HPLC method for quality control of Alpinia zerumbet

Planta Medica ◽  
2013 ◽  
Vol 79 (13) ◽  
Author(s):  
I Cardoso ◽  
M Tappin ◽  
M Nakamura ◽  
H Pereira ◽  
M Behrens
Keyword(s):  
Quality Control ◽  
Hplc Method ◽  
Alpinia Zerumbet

Chemical Fingerprint Analysis and Simultaneous Determination of Nucleosides and Amino Acids in Kang Fu Xin Liquid by High Performance Liquid Chromatography with Diode Array Detector

2020 ◽  
Vol 16 (7) ◽  
pp. 831-843
Author(s):  
Yuwen Wang ◽  
Shuping Li ◽  
Liuhong Zhang ◽  
Shenglan Qi ◽  
Huida Guan ◽  
...  
Keyword(s):  
Amino Acids ◽  
Quality Control ◽  
Uric Acid ◽  
Control Method ◽  
Principal Component ◽  
Gradient Elution ◽  
Hplc Method ◽  
Array Detector ◽  
Fingerprint Analysis ◽  
Wavelength Switching

Background and Objective: Kang Fu Xin liquid (KFX) is an official preparation made from the ethanol extract product from P. Americana. The present quality control method cannot control the quality of the preparation well. The aim of the present study is to establish a convenient HPLC method for multicomponents determination combined with fingerprint analysis for quality control of KFX. Methods: An HPLC-DAD method with gradient elution and detective wavelength switching program was developed to establish HPLC fingerprints of KFX, and 38 batches of KFX were compared and evaluated by similarity analysis (SA), hierarchical clustering analysis (HCA), and principal component analysis (PCA). Meanwhile, six nucleosides and three amino acids, including uracil, hypoxanthine, uric acid, adenosine, xanthine, inosine, tyrosine, phenylalanine and tryptophan in KFX were determined based on the HPLC fingerprints. Results: An HPLC method assisted with gradient elution and wavelength switching program was established and validated for multicomponents determination combined with fingerprint analysis of KFX. The results demonstrated that the similarity values of the KFX samples were more than 0.845. PCA indicated that peaks 4 (hypoxanthine), 7 (xanthine), 9 (tyrosine), 11, 13 and 17 might be the characteristic contributed components. The nine constituents in KFX, uracil, hypoxanthine, uric acid, adenosine, xanthine, inosine, tyrosine, phenylalanine and tryptophan, showed good regression (R2 > 0.9997) within test ranges and the recoveries of the method for all analytes were in the range from 96.74 to 104.24%. The limits of detections and quantifications for nine constituents in DAD were less than 0.22 and 0.43 μg•mL-1, respectively. Conclusion: The qualitative analysis of chemical fingerprints and the quantitative analysis of multiple indicators provide a powerful and rational way to control the KFX quality for pharmaceutical companies.

scholarly journals Secondary Effects of Hypochlorite Treatment on the Emerging Pollutant Candesartan: The Formation of Degradation Byproducts and Their Toxicological Profiles

Molecules ◽  
2021 ◽  
Vol 26 (11) ◽  
pp. 3422
Author(s):  
Giovanni Luongo ◽  
Lorenzo Saviano ◽  
Giovanni Libralato ◽  
Marco Guida ◽  
Antonietta Siciliano ◽  
...  
Keyword(s):  
Wastewater Treatment Plants ◽  
Parent Compound ◽  
Antihypertensive Agents ◽  
Parent Drug ◽  
Degradation Pathway ◽  
Hplc Method ◽  
Chlorination Process ◽  
Emerging Pollutant ◽  
Ecotoxicity Tests ◽  
First Time

In recent years, many studies have reported the frequent detection of antihypertensive agents such as sartans (olmesartan, valsartan, irbesartan and candesartan) in the influents and effluents of wastewater treatment plants (WWTPs) and in the superficial waters of rivers and lakes in both Europe and North America. In this paper, the degradation pathway for candesartan (CAN) was investigated by simulating the chlorination process that is normally used to reduce microbial contamination in a WWTP. Twelve isolated degradation byproducts (DPs), four of which were isolated for the first time, were separated on a C-18 column by employing a gradient HPLC method, and their structures were identified by combining nuclear magnetic resonance and mass spectrometry and comparing the results with commercial standards. On the basis of these results, a mechanism of formation starting from the parent drug is proposed. The ecotoxicity of CAN and its DPs was studied by conducting a battery of ecotoxicity tests; bioassays were performed using Aliivibrio fischeri (bacterium), Daphnia magna (planktonic crustacean) and Raphidocelis subcapitata (alga). The ecotoxicity results shed new light on the increased toxicity of DPs compared with the parent compound.

scholarly journals Genetic Similarity of Avena sativa L. Varieties as an Example of a Narrow Genetic Pool of Contemporary Cereal Species

Plants ◽  
2021 ◽  
Vol 10 (7) ◽  
pp. 1424
Author(s):  
Magdalena Cieplak ◽  
Sylwia Okoń ◽  
Krystyna Werwińska
Keyword(s):  
Genetic Diversity ◽  
Avena Sativa ◽  
Genetic Similarity ◽  
Breeding Programs ◽  
Central European ◽  
Cereal Species ◽  
Genetic Pool ◽  
Selection Of ◽  
High Genetic Similarity

The assessment of the genetic diversity of cultivated varieties is a very important element of breeding programs. This allows the determination of the level of genetic differentiation of cultivated varieties, their genetic distinctiveness, and is also of great importance in the selection of parental components for crossbreeding. The aim of the present study was to determine the level of genetic diversity of oat varieties currently grown in Central Europe based on two marker systems: ISSR and SCoT. The research conducted showed that both these types of markers were suitable for conducting analyses relating to the assessment of genetic diversity. The calculated coefficients showed that the analyzed cultivars were characterized by a high genetic similarity. However, the UPGMA and PCoA analyses clearly indicated the distinctiveness of the breeding programs conducted in Central European countries. The high genetic similarity of the analyzed forms allow us to conclude that it is necessary to expand the genetic pool of oat varieties. Numerous studies show that landraces may be the donor of genetic variation.

scholarly journals Development and Validation of a GMP-Compliant High-Pressure Liquid Chromatography Method for the Determination of the Chemical and Radiochemical Purity of [18F]PSMA-1007, a PET Tracer for the Imaging of Prostate Cancer

2021 ◽  
Vol 14 (3) ◽  
pp. 188
Author(s):  
Ines Katzschmann ◽  
Heike Marx ◽  
Klaus Kopka ◽  
Ute Hennrich
Keyword(s):  
Prostate Cancer ◽  
Quality Control ◽  
Radiochemical Purity ◽  
Control Method ◽  
Solid Phase ◽  
Hplc Method ◽  
Attractive Alternative ◽  
Chromatography Method ◽  
Pet Tracer

For the PET imaging of prostate cancer, radiotracers targeting the prostate-specific membrane antigen (PSMA) are nowadays used in clinical practice. [18F]PSMA-1007, a radiopharmaceutical labeled with fluorine-18, has excellent properties for the detection of prostate cancer. Essential for the human use of a radiotracer is its production and quality control under GMP-compliance. For this purpose, all analytical methods have to be validated. [18F]PSMA-1007 is easily radiosynthesized in a one-step procedure and isolated using solid phase extraction (SPE) cartridges followed by formulation of a buffered injection solution and for the determination of its chemical and radiochemical purity a robust, fast and reliable quality control method using radio-HPLC is necessary. After development and optimizations overcoming problems in reproducibility, the here described radio-HPLC method fulfills all acceptance criteria—for e.g., specificity, linearity, and accuracy—and is therefore well suited for the routine quality control of [18F]PSMA-1007 before release of the radiopharmaceutical. Recently a European Pharmacopeia monograph for [18F]PSMA-1007 was published suggesting a different radio-HPLC method for the determination of its chemical and radiochemical purity. Since the here described method has certain advantages, not least of all easier technical implementation, it can be an attractive alternative to the monograph method. The here described method was successfully validated on several radio-HPLC systems in our lab and used for the analysis of more than 60 batches of [18F]PSMA-1007. Using this method, the chemical and radiochemical purity of [18F]PSMA-1007 can routinely be evaluated assuring patient safety.

Identification, Characterization, and Quantification of Impurities of Safinamide Mesilate: Process-Related Impurities and Degradation Products

2017 ◽  
Vol 100 (4) ◽  
pp. 1029-1037 ◽  
Author(s):  
Liang Zou ◽  
Lili Sun ◽  
Hui Zhang ◽  
Wenkai Hui ◽  
Qiaogen Zou ◽  
...  
Keyword(s):  
Degradation Products ◽  
Hplc Method ◽  
Formation Mechanisms ◽  
Stability Indicating ◽  
Related Impurities ◽  
Related Substances ◽  
Water Ph ◽  
Bulk Drug ◽  
First Time

Abstract The characterization of process-related impurities and degradation products of safinamide mesilate (SAFM) in bulk drug and a stability-indicating HPLC method for the separation and quantification of all the impurities were investigated. Four process-related impurities (Imp-B, Imp-C, Imp-D, and Imp-E) were found in the SAFM bulk drug. Five degradation products (Imp-A, Imp-C, Imp-D, Imp-E, and Imp-F) were observed in SAFM under oxidative conditions. Imp-C, Imp-D, and Imp-E were also degradation products and process-related impurities. Remarkably, one new compound, identified as (S)-2-[4-(3-fluoro-benzyloxy) benzamido] propanamide (i.e., Imp-D), is being reported here as an impurity for the first time. Furthermore, the structures of the aforementioned impurities were characterized and confirmed via IR, NMR, and MS techniques, and the most probable formation mechanisms of all impurities proposed according to the synthesis route. Optimum separation was achieved on an Inertsil ODS-3 column (250 × 4.6 mm, 5 μm), using 0.1% formic acid in water (pH adjusted to 5.0) and acetonitrile as the mobile phase in gradient mode. The proposed method was found to be stability-indicating, precise, linear, accurate, sensitive, and robust for the quantitation of SAFM and its process-related substances, including its degradation products.

scholarly journals Anti-diabetes Constituents in Leaves of Smallanthus sonchifolius

2010 ◽  
Vol 5 (1) ◽  
pp. 1934578X1000500 ◽  
Author(s):  
Xiang Zheng ◽  
He Fan ◽  
Kang Ting-Guo ◽  
Dou De-Qiang ◽  
Gai Kuo ◽  
...  
Keyword(s):  
Quality Control ◽  
Chlorogenic Acid ◽  
Caffeic Acid ◽  
Analytical Method ◽  
Inhibitory Effect ◽  
Hplc Method ◽  
Smallanthus Sonchifolius ◽  
Rp Hplc

The inhibitory effect of smallanthaditerpenic acids A, B, C and D previously isolated from leaves of Smallanthus sonchifolius (yacon) on α-glucosidase were examined and their IC50 were determined to be 0.48 mg/mL, 0.59 mg/mL, 1.00 mg/mL, and 1.17 mg/mL respectively. In addition, a rapid, reliable RP-HPLC method for the analysis of chlorogenic acid, caffeic acid, and smallanthaditerpenic acids A and C in yacon leaves was established, and the variation in their contents in leaves from plants cultivated in different places and collected at different times of the year were compared. The established analytical method for determining smallanthaditerpenic acids A and C, chlorogenic acid and caffeic acid presented good results and could be used as a method for the quality control of S. sonchifolius leaves.

PROJECT DEVELOPMENT OF THE NATIONAL STANDARD ON QUALITY CONTROL AND IDENTIFICATION OF THE CHEWING TOBACCO

2019 ◽  
Author(s):  
Н.П. САМОЙЛЕНКО ◽  
И.Г. КАНДАШКИНА ◽  
Е.В. ГНУЧИХ ◽  
Л.А. МИРНЫХ
Keyword(s):  
Quality Control ◽  
Smokeless Tobacco ◽  
Fractional Composition ◽  
National Standard ◽  
Tobacco Products ◽  
Chewing Tobacco ◽  
Smokeless Tobacco Products ◽  
Technical Specifications ◽  
First Time ◽  
General Technical

Рассмотрены идентификационные признаки некурительных табачных изделий табака жевательного и снюса. Разработан метод определения фракционного состава табака жевательного. На основании научных исследований впервые разработан проект национального стандарта ГОСТ Р Табак жевательный. Общие технические условия, который после утверждения и введения в действие будет использоваться для идентификации этого вида некурительной табачной продукции. The identification signs of smokeless tobacco products: of chewing tobacco and snus are considered. A method for determining the fractional composition of chewing tobacco has been developed. On the basis of scientific research for the first time developed a draft national standard GOST R Chewing tobacco. General technical specifications. After approval and entry into force, this standard will be used to identify types of smokeless tobacco products.

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