scholarly journals Innovative methodologies for identification and qualification of Impurities: An overview of the latest trends on impurity profiling

2020 ◽  
Vol 11 (3) ◽  
pp. 2909-2921
Author(s):  
Nishanth G ◽  
Akhila G ◽  
Anandkumar Tengli ◽  
Chandan R S ◽  
Suraj K ◽  
...  
Keyword(s):  
Pharmaceutical Research ◽  
Analytical Techniques ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Products ◽  
Analytical Methodology ◽  
Drug Products ◽  
Technical Developments ◽  
Drug Substances ◽  
Impurity Profiling ◽  
Bulk Drug

Impurity profiling is known to identify, classify and measure both the identified and non-identified contamination present on the medicinal product. Unwanted chemicals which remain or are created during the formulation of medicinal products are pharmaceutical impurities. Impurity profiling helps in the detection, recognition and quantification in bulk products and pharmaceutical formulations of various types of impurities, as well as residual solvents. It is the simplest way to distinguish consistency and stability of bulk drugs and medication formulations. As analytical methodology has developed rapidly, it is essential to consider with their solutions problems related to impurities of drug substances and drug products. Various regulatory agencies including ICH, USFDA, Canadian Drug and Health Agencies stress the criteria for purity and for detecting impurities in active pharmaceutical materials, even in small quantities, as the presence of impurities, may have an effect on pharmaceutical products ’ efficacy and health. Therefore, the study focuses on various analytical methods for identification and quantification of impurities in pharmaceutical products to clarify the need for impurity profiling on drug products in pharmaceutical research. To drug regulators, the product substance’s impurity profile is a reliable fingerprint to prove that the manufacturing process of bulk drug substances is consistent in quality. The study gives a short summary of recent technical developments in the profiling of pharmaceutical products including pharmaceutical active ingredients as well as pharmaceutical products during 2013-2017. Such recent trends in the profiling of impurities have been addressed in the study. This focuses specifically on a thorough update on various analytical techniques, including hyphenated methods to define and measure thresholds in specific pharmaceutical matrices of impurities and degradants.

Impurity Profiling-A Significant Approach in Pharmaceuticals

2019 ◽  
Vol 15 (7) ◽  
pp. 669-680
Author(s):  
Dipankar Nath ◽  
Bidhya Sharma
Keyword(s):  
Degradation Products ◽  
Health Agency ◽  
Drug Products ◽  
Regulatory Authorities ◽  
Drug Substances ◽  
Impurity Profiling ◽  
Quality Control Tool ◽  
Mandatory Requirement ◽  
Bulk Drug

There has been ever increasing interest in impurities present in Active Pharmaceutical Ingredient’s (API’s). Nowadays, not only purity profile but also impurity profile has become mandatory according to the various regulatory authorities. In the pharmaceutical world, an impurity is considered as an inorganic or organic material, or residual solvents other than the drug substances, or ingredients, arising out of synthesis or unwanted chemicals that remains with APIs. Impurity profiling includes identification, structure elucidation and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulation. The control of impurities in Formulated products and API’s were regulated by various regulatory authorities like ICH, USFDA, Canadian Drug, and Health Agency. Impurity profiling is very important in the modern pharmaceutical analysis due to the fact that unidentified, potentially toxic impurities are hazardous to health and in order to increase the safety of drug therapy, impurities should be identified and determined by the selective method. Nowadays, it is a mandatory requirement in various pharmacopeias to know the impurities present in APIs and finished drug products. Thus, impurity profiling can act as a Quality Control tool. It can provide crucial data regarding the toxicity, safety, various limits of detection and limits of quantitation of several organic and inorganic impurities, usually accompany with APIs and finished products. There is a strong requirement to have unique specifications/standards with regard to impurities.

scholarly journals APPLICATION OF LIQUID CHROMATOGRAPHY COUPLED WITH MASS SPECTROMETRY IN THE IMPURITY PROFILING OF DRUG SUBSTANCES AND PRODUCTS

2018 ◽  
Vol 11 (5) ◽  
pp. 30
Author(s):  
Akshatha H S ◽  
Gurupadayya Bm
Keyword(s):  
Mass Spectrometry ◽  
Liquid Chromatography ◽  
High Sensitivity ◽  
Pharmaceutical Formulations ◽  
Active Pharmaceutical Ingredient ◽  
Hyphenated Techniques ◽  
Drug Substances ◽  
Impurity Profiling ◽  
Short Period

As the drug safety and efficacy is hampered in the presence of an impurity, the international regulatory agencies laid down stringent limits for the control of impurities in the active pharmaceutical ingredient and pharmaceutical formulations. The conventional approaches lack the characterization of impurities in trace levels, due to sensitivity issues, hyphenated techniques are preferred. Among the modern hyphenated techniques, liquid chromatography-mass spectrometry (LC-MS) has high sensitivity and can analyze large number of organic compounds in a short period of time. In the present study, the impurity profiling of various drug substances and products using LC-MS about past 6 years were retrospect for its importance, instrumentations, and applications.

Accelerating pre-formulation investigations in early drug product lifecycle using predictive methodologies and computational algorithms

2021 ◽  
Author(s):  
Harsh S Shah ◽  
Kaushalendra Chaturvedi ◽  
Shanming Kuang ◽  
Jian Wang
Keyword(s):  
Case Studies ◽  
Drug Product ◽  
Analytical Techniques ◽  
Cost Effective ◽  
Product Lifecycle ◽  
Predictive Tools ◽  
Drug Products ◽  
Current Trends ◽  
Drug Substances ◽  
Early Drug

Precisely developed computational methodologies can allow the drug product lifecycle process to be time-efficient, cost-effective and reliable through a thorough fundamental understanding at the molecular level. Computational methodologies include computational simulations, virtual screening, mathematical modeling and predictive tools. In light of current trends and increased expectations of product discovery in early pharmaceutical development, we have discussed different case studies. These case studies clearly demonstrate the successful application of predictive tools alone or in combination with analytical techniques to predict the physicochemical properties of drug substances and drug products, thereby shortening research and development timelines. The overall goal of this report is to summarize unique predictive methodologies, which can assist pharmaceutical scientists in achieving time-sensitive research goals and avoiding associated risks that can potentially affect the drug product quality.

Review on Analytical Methods for Estimation of Vildagliptin in Bulk and Pharmaceutical Dosage form

2021 ◽  
pp. 157-162
Author(s):  
Vaishnavi Aher ◽  
S. D. Mankar ◽  
G. S. Shinde
Keyword(s):  
Internal Control ◽  
Decisive Role ◽  
Analytical Techniques ◽  
Pharmaceutical Formulations ◽  
Analytical Methodology ◽  
Pharmaceutical Dosage Form ◽  
Methodology Development ◽  
Dipeptidyl Peptidase 4 ◽  
Analytical Instruments ◽  
Pharmaceutical Industries

Vildagliptin is approved by USFDA in 2007. Vildagliptin s- l-[n-(3-hydroxy-1-adamantyl) glycyl] pyrrolidine-2- carbonitrile is associate degree oral antihyperglycaemic agent (anti-diabetic drug) of the new dipeptidyl peptidase-4 (dpp-4) substance category of medicine. The present work categorical the new easy, accurate, precise analytical methodology for the determination of vildagliptin in bulk and pharmaceutical indefinite quantity kind. Analytical techniques play a decisive role by providing solutions like improvement. This paper could be a review and classification of the various analytical techniques that are the foremost widely-used in determination common provision issues. Pharmaceutical analysis plays an awfully outstanding conspicuous role in quality assurance similarly as internal control of bulk medication and pharmaceutical formulations. Fast increase in pharmaceutical industries and production of drug in numerous components of the globe has brought an increase in demand for brand new analytical techniques within the pharmaceutical industries. As a consequence, analytical methodology development has become the essential activity of study. Recent development in analytical ways has been resulted from the advancement of analytical instruments.

scholarly journals POLYMORPHISM AND POLYMORPH CHARACTERISATION IN PHARMACEUTICALS

2019 ◽  
Vol 8 (5) ◽  
Author(s):  
Dr Amit Gosar ◽  
Dr Sayyed Hussain ◽  
Dr Tabrez Shaikh
Keyword(s):  
Drug Product ◽  
Analytical Techniques ◽  
Spectroscopic Properties ◽  
Crystalline Form ◽  
Kinetic Properties ◽  
Specific Chemical ◽  
Safety And Efficacy ◽  
Drug Products ◽  
Drug Substances ◽  
The Given

Polymorphism is the ability of a specific chemical compound to crystallize in more than one crystalline form. Polymorphs had a different arrangement of the molecule in the given crystal lattice and  may properties such as packing properties, thermodynamic properties, spectroscopic properties, kinetic properties, surface properties and mechanical properties. Polymorph can be classified in various class such as crystalline, amorphous, hydrate and solvate. Polymorphs are categorized into two types, enantiotropes and monotropes, depending upon their stability with respect to the range of temperatures and pressures. There are various guidelines for the control of polymorphs in drug substances and drug product. Different analytical techniques are used for the detection, quantification and characterisation of the polymorphs in the drug substances and drug products. Control of polymorph in a drug substance and drug product is important for the safety and efficacy of the drug. Keywords: Polymorphism, classification, guidelines, characterisation, drug substances.

Pharmaceutical Polymers - A Review

2019 ◽  
Vol 9 (01) ◽  
pp. 27-33
Author(s):  
Naveen Kumar ◽  
Sonia Pahuja ◽  
Ranjit Sharma
Keyword(s):  
Drug Release ◽  
Industrial Revolution ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Products ◽  
Water Soluble ◽  
Taste Masking ◽  
Natural Polymers ◽  
Pharmaceutical Dosage Forms ◽  
Pharmaceutical Applications ◽  
Pharmaceutical Industries

Humans have taken advantage of the adaptability of polymers for centuries in the form of resins, gums tars, and oils. However, it was not until the industrial revolution that the modern polymer industry began to develop. Polymers represent an important constituent of pharmaceutical dosage forms. Polymers have played vital roles in the formulation of pharmaceutical products. Polymers have been used as a major tool to manage the drug release rate from the formulations. Synthetic and natural-based polymers have found their way into the biomedical and pharmaceutical industries. Synthetic and Natural polymers can be produced with a broad range of strength, heat resistance, density, stiffness and even price. By constant research into the science and applications of polymers, they are playing an ever-increasing role in society. Diverse applications of polymers in the present pharmaceutical field are for controlled drug release. Based on solubility pharmaceutical polymers can be classified as water-soluble and water-insoluble. In general, the desirable polymer properties in pharmaceutical applications are film forming, adhesion, gelling, thickening, pH-dependent solubility and taste masking. General pharmaceutical applications of polymers in various pharmaceutical formulations are also discussed

scholarly journals Mycotoxin Analysis: New Proposals for Sample Treatment

2014 ◽  
Vol 2014 ◽  
pp. 1-12 ◽  
Author(s):  
Natalia Arroyo-Manzanares ◽  
José F. Huertas-Pérez ◽  
Ana M. García-Campaña ◽  
Laura Gámiz-Gracia
Keyword(s):  
Raw Materials ◽  
Animal Health ◽  
Analytical Techniques ◽  
Sample Treatment ◽  
Analytical Technique ◽  
Chemical Structures ◽  
Technical Developments ◽  
Food And Feed ◽  
Ultrahigh Performance Liquid Chromatography ◽  
Food Commodities

Mycotoxins are toxic secondary metabolites produced by different fungi, with different chemical structures. Mycotoxins contaminate food, feed, or raw materials used in their production and cause diseases and disorders in humans and livestock. Because of their great variety of toxic effects and their extreme heat resistance, the presence of mycotoxins in food and feed is considered a high risk to human and animal health. In order to ensure food quality and health consumers, European legislation has set maximum contents of some mycotoxins in different matrices. However, there are still some food commodities susceptible to fungal contamination, which were not contemplated in this legislation. In this context, we have developed new analytical techniques for the multiclass determination of mycotoxins in a great variety of food commodities (some of them scarcely studied), such as cereals, pseudocereals, cereal syrups, nuts, edible seeds, and botanicals. Considering the latest technical developments, ultrahigh performance liquid chromatography coupled to tandem mass spectrometry has been chosen as an efficient, fast, and selective powerful analytical technique. In addition, alternative sample treatments based on emerging methodologies, such as dispersive liquid-liquid microextraction and QuEChERS, have been developed, which allow an increased efficiency and sample throughput, as well as reducing contaminant waste.

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