Development and Characterization of a Cocrystal as a Viable Solid Form for an Active Pharmaceutical Ingredient

2013 ◽  
Vol 17 (3) ◽  
pp. 540-548 ◽  
Author(s):  
Soojin Kim ◽  
Zhibin Li ◽  
Yin-Chao Tseng ◽  
Herbert Nar ◽  
Earl Spinelli ◽  
...  
Keyword(s):  
Active Pharmaceutical Ingredient ◽  
Solid Form

Characterization of low-abundance species in the active pharmaceutical ingredient of CIGB-300: A clinical-grade anticancer synthetic peptide

2018 ◽  
Vol 24 (6) ◽  
pp. e3081 ◽  
Author(s):  
Hilda Garay ◽  
Luis Ariel Espinosa ◽  
Yasser Perera ◽  
Aniel Sánchez ◽  
David Diago ◽  
...  
Keyword(s):  
Synthetic Peptide ◽  
Active Pharmaceutical Ingredient ◽  
Clinical Grade

scholarly journals Phytoliths as Emerging Taxonomic Tools for Identification of Plants: An Overview

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Sheikh Abdul Shakoor ◽  
Mudassir Ahmad Bhat
Keyword(s):  
Plant Species ◽  
Morphometric Parameters ◽  
Taxonomic Analysis ◽  
Reproductive Structures ◽  
Plant Groups ◽  
The Family ◽  
Solid Form ◽  
Orientation Pattern ◽  
Different Levels

In the recent advancements in identification of plant species, phytoliths have found an immense role in the identification of plants at different levels of taxonomic hierarchy. Many plant groups are known to accumulate silica in solid form in and between the cells and tissues and hence create the structures commonly known as phytoliths. These phytoliths create replicas of the structures where they are deposited. The shapes of phytolith replicas, their size dimensions (morphometric parameters), surface features (ornamentation), distribution, and orientation pattern in epidermal layers of vegetative and reproductive structures as well as their frequency are highly important for characterization of species. Monocotyledonous families particularly the family Poaceae (Gramineae) are known to produce diverse phytolith types that can serve as diagnostic markers for characterization of different taxa at different levels of taxonomic hierarchy. The present paper highlights the importance of phytoliths in taxonomic analysis of plants particularly in the family Poaceae.

scholarly journals Spectroscopic Characterization of Omeprazole and Its Salts

2017 ◽  
Vol 2017 ◽  
pp. 1-11
Author(s):  
Tomislav Vrbanec ◽  
Primož Šket ◽  
Franci Merzel ◽  
Matej Smrkolj ◽  
Jože Grdadolnik
Keyword(s):  
Vibrational Spectroscopy ◽  
Alkali Metals ◽  
Alkaline Earth ◽  
Active Pharmaceutical Ingredient ◽  
Spectroscopic Characterization ◽  
Infrared And Raman Spectroscopy ◽  
Acid Environment ◽  
Ph Range ◽  
Spectroscopic Tool

During drug development, it is important to have a suitable crystalline form of the active pharmaceutical ingredient (API). Mostly, the basic options originate in the form of free base, acid, or salt. Substances that are stable only within a certain pH range are a challenge for the formulation. For the prazoles, which are known to be sensitive to degradation in an acid environment, the formulation is stabilized with alkaline additives or with the application of API formulated as basic salts. Therefore, preparation and characterization of basic salts are needed to monitor any possible salinization of free molecules. We synthesized salts of omeprazole from the group of alkali metals (Li, Na, and K) and alkaline earth metals (Mg, Ca). The purpose of the presented work is to demonstrate the applicability of vibrational spectroscopy to discriminate between the OMP and OMP-salt molecules. For this reason, the physicochemical properties of 5 salts were probed using infrared and Raman spectroscopy, NMR, TG, DSC, and theoretical calculation of vibrational frequencies. We found out that vibrational spectroscopy serves as an applicable spectroscopic tool which enables an accurate, quick, and nondestructive way to determine the characteristic of OMP and its salts.

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.

Identification and characterization of degradation products of indacaterol using liquid chromatography/mass spectrometry

2020 ◽  
Vol 26 (6) ◽  
pp. 425-431
Author(s):  
Naga Veera Yerra ◽  
S Babu Dadinaboyina ◽  
LSSN Vigjna Abbaraju ◽  
MVN Kumar Talluri ◽  
Jagadeshwar Reddy Thota
Keyword(s):  
Degradation Products ◽  
Thermal Conditions ◽  
Active Pharmaceutical Ingredient ◽  
Stress Conditions ◽  
Chronic Obstructive ◽  
Forced Degradation ◽  
Obstructive Pulmonary Disease ◽  
Guide Lines ◽  
Identification And Characterization

Indacaterol (IND), 5-[2-[(5,6-Diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxyquinolin-2(1H)-one, is an active pharmaceutical ingredient (API) which is used to treat chronic obstructive pulmonary disease (COPD). We followed the International Council for Harmonization (ICH) guide lines to study the degradation behavior of IND under various stress conditions. Stressed degradation of the drug was performed under hydrolytic (alkaline, acidic and neutral), photolytic, oxidative and thermal conditions. Identification and characterization of IND and its forced degradation products (DPs) were demonstrated by using LC-HRMS and MS/MS method. A total of three DPs (DP1-DP3) were identified and characterized. The IND was found to be stable under photolytic, oxidative and thermal conditions, whereas it produced three DPs in acidic, basic and neutral hydrolytic stress conditions.

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