scholarly journals A Review on – Estimation of Residual Solvents by Different Analytical Method

2021 ◽  
Vol 69 (1) ◽  
Author(s):  
D. Umamaheswari ◽  
Neha Gupta T ◽  
M. Kumar ◽  
B.S. Venkateswarlu
Keyword(s):  
Thermogravimetric Analysis ◽  
Ir Spectroscopy ◽  
Therapeutic Effect ◽  
Analytical Method ◽  
Residual Solvents ◽  
Near Ir ◽  
Pharmaceutical Substances ◽  
Standard Management ◽  
Ich Guidelines ◽  
Solvent Residues

Residual solvents are the unwanted substances (solvents) used or created throughout the manufacture of a excipients, drug or pharmaceutical formulation and don't seem to be utterly removed by sensible ways within the final finished product. These solvents may be harmful in nature. Therefore, analysis of residual solvents becomes a necessary tool for the standard management of prescribed drugs. The appropriate limits for these substances are given in ICH. Solvents are widely used during the manufacturing, purification and processing of pharmaceutical substances. The residues of these solvents must be removed to the extent possible, as they do not have any therapeutic effect but can cause undesirable effects in the consumers. These solvent residues concentrationshould not exceed the limits prescribed in the ICH guidelines. This present review work is emphasized on various techniques (Loss on drying, Thermogravimetric analysis, Near- IR spectroscopy).

Development and Validation of an Eco-Friendly and Low-Cost Method for the Quantification of Cefepime Hydrochloride in Powder for Injectable Solution Using Infrared (IR) Spectroscopy

2020 ◽  
Vol 16 (4) ◽  
pp. 456-464
Author(s):  
Danilo F. Rodrigues ◽  
Hérida R.N. Salgado
Keyword(s):  
Ir Spectroscopy ◽  
Low Cost ◽  
Pharmaceutical Preparations ◽  
Potassium Bromide ◽  
Pharmaceutical Products ◽  
Injectable Formulation ◽  
Ich Guidelines ◽  
Lactam Ring ◽  
Development And Validation

Background: A simple, eco-friendly and low-cost Infrared (IR) method was developed and validated for the analysis of Cefepime Hydrochloride (CEF) in injectable formulation. Different from some other methods, which employ organic solvents in the analyses, this technique does not use these types of solvents, removing large impacts on the environment and risks to operators. Objective: This study aimed at developing and validating a green analytical method using IR spectroscopy for the determination of CEF in pharmaceutical preparations. Methods: The method was validated according to ICH guidelines and the quantification of CEF was performed in the spectral region absorbed at 1815-1745 cm-1 (stretching of the carbonyl group of β- lactam ring). Results: The validated method showed to be linear (r = 0.9999) in the range of 0.2 to 0.6 mg/pellet of potassium bromide, as well as for the parameters of selectivity, precision, accuracy, robustness and Limits of Detection (LOD) and Quantification (LOQ), being able to quantify the CEF in pharmaceutical preparations. The CEF content obtained by the IR method was 103.86%. Conclusion: Thus, the method developed may be an alternative in the quality control of CEF sample in lyophilized powder for injectable solution, as it presented important characteristics in the determination of the pharmaceutical products, with low analysis time and a decrease in the generation of toxic wastes to the environment.

Broadband Mid-IR Spectroscopy with Near-IR Grating Spectrometers

2021 ◽  
Author(s):  
Paul Kaufmann ◽  
Helen M. Chrzanowski ◽  
Aron Vanselow ◽  
Sven Ramelow
Keyword(s):  
Ir Spectroscopy ◽  
Near Ir

Near-IR Spectroscopy of Blue Supergiants

2009 ◽  
pp. 55-60 ◽  
Author(s):  
N. Przybilla ◽  
A. Seifahrt ◽  
K. Butler ◽  
M. F. Nieva ◽  
H.-U. Käufl ◽  
...  
Keyword(s):  
Ir Spectroscopy ◽  
Near Ir

Analytical Method Development and Validation of Glipizide to Determine Residual solvents by head Space-Gas Chromatography

2021 ◽  
pp. 2440-2444
Author(s):  
Sanapala Srinivasa Rao ◽  
A. Vijayalakshmi
Keyword(s):  
Gas Chromatography ◽  
Method Development ◽  
Limit Of Detection ◽  
Dimethyl Formamide ◽  
Analytical Methodology ◽  
Residual Solvents ◽  
Flame Ionization ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation

Residual solvents in Pharmaceuticals are termed as organic volatile impurities. These are the chemicals that are used in the manufacture of drug substance or excipients or use in the preparation of final formulation. Most of the available methods use liquid chromatography which could be expensive and time consuming. Hence, an analytical methodology was developed for the quantification of residual solvents in Glipizide using a headspace gas chromatography (HSGC) with the help of flame ionization detector (FID). Methanol, acetone and dimethyl formamide as residual solvents were determined in Glipizide. Analysis was performed by headspace GC/FID method on Auto system- HS40. Nitrogen was used as a carrier gas and the separation of residual solvents was achieved by DB-Wax 0.25mm, 0.3mcm column. The thermostat temperature was 115 °C for 40 minutes for each vial. % RSD for nine injections obtained are in acceptance criteria. The correlation coefficient R2 obtained greater than 0.99. The method parameters were validated includes specificity, limit of detection and quantification, accuracy, linearity, precision, and robustness. According to the International Conference on Harmonization (ICH) guidelines, a new simple, specific, accurate and precise method was developed and validated.

Assessment of compliance level of ICH guidelines for organic volatile impurities in common ayurvedic hepatic formulations

2019 ◽  
Vol 16 (3) ◽  
Author(s):  
M. Maithani ◽  
R. Raturi ◽  
V. Gupta ◽  
P. Bansal
Keyword(s):  
Liver Diseases ◽  
Herbal Medicines ◽  
Formulation Development ◽  
Residual Solvents ◽  
Permissible Limits ◽  
Flame Ionization ◽  
Ich Guidelines ◽  
Long Time ◽  
Gas Chromatographic Method ◽  
Volatile Impurities

Abstract Background Herbal medicines have been used in the treatment of liver diseases for a long time. In recent years, the use of herbal medicines for protection from other strong antibiotics as well as drugs that can damage the liver during their metabolism in liver and for treatment of liver diseases has increased all over the world. It is important to mention that a number of organic solvents are used at different stages of extraction/formulation development for these traditional preparations in industries/pharmacies. In addition, some of these solvents possess established carcinogenic properties and may enter the formulation as residual solvents. Hence as per ICH guidelines it is mandatory to keep the level of these solvents up to permissible limits. There has been a lot of hue and cry that ayurvedic formulations available in the market are not properly standardized for their quality due to lack of stringent regulations and standards from regulatory authorities. Therefore the aim of present work was to assess the compliance of ICH guidelines for level of organic volatile impurities in common marketed ayurvedic hepatic formulations. Methods In this study, 25 ayurvedic herbal formulations available as OTC product have been assessed for presence of residual solvents using gas chromatography with flame ionization detector. Results This study on 25 fast moving hepatic formulations in the market reflects that no residual solvents were detected in any of the formulations however if present were within prescribed permissible limits of ICH guidelines. The data was also subjected to statistical analysis (F-test and t-test at 95% confidence level). Conclusions Results indicate the safety of these hepatic formulations with respect to residual solvents. In addition presents a simple, linear, specific, accurate, precise and rugged gas chromatographic method for estimation of residual solvents.

scholarly journals Very Low Mass Stars and Brown Dwarf Candidates in Orion OB1a and OB1b

2003 ◽  
Vol 211 ◽  
pp. 119-122
Author(s):  
Frederick M. Walter ◽  
William H. Sherry ◽  
Scott J. Wolk
Keyword(s):  
Ir Spectroscopy ◽  
Main Sequence ◽  
Brown Dwarf ◽  
Low Mass Stars ◽  
Space Density ◽  
Near Ir ◽  
Substellar Objects ◽  
Low Mass ◽  
M Stars

VRI images within the belt of Orion and the Ori OB1a association reveal a pre-main sequence locus extending to below our completeness limit of about V=21. We report here on followup JHK imaging and optical and near–IR spectroscopy of the faintest and reddest of the PMS candidates. We find that they are unreddened mid-to-late M “stars” which fall on a few million year isochrone. Masses are largely substellar, reaching as low as about 0.02 M⊙ (20 Jovian masses). The space density of the substellar objects is high.

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