importance of moisture content determination in pharmaceuticals

Drying oven vs. Halogen Moisture Analyzer guide will be of interest to anyone involved in moisture analysis applications in pharmaceutical, chemical, food or other industries, as moisture content affects the quality, shelf-life and usability of a wide array of end products. The standard method for moisture determination is Karl Fischer (KF) titration, based on either volumetry or The moisture content of a piece of timber is something many of us take for granted. Log in Join now Secondary School. Through the process of dynamic vapor sorption (DVS), the quantitative uptake of moisture can be measured, and the resultant data used to accurately calculate amorphous content. Water determination plays an important role in the pharmaceutical analysis. The purpose of this study is to investigate the effects of moisture content on the storage stability of freeze‐dried lipoplex formulations. Automation allows for accurate and highly repeatable water content determination. The moisture content in the 42 creams were first determined by KF titration procedure in triplicates and were found to be between 60% to 80%. By far, the most important method for determining the water content of pharmaceuticals is the Karl Fischer titration. Whilst no attempt is made to give a comprehensive review of methods of moisture content determination, the principles of the various methods used are discussed and the importance of the relationship between the moisture content of a product and its storage potential is stressed. The present study confirmed that NIR spectroscopy could be used in the PAT concept as a non-invasive, non-destructive and fast technique for moisture content determination in pharmaceutical pellets. Measuring Moisture Content There are many methods for measuring the moisture content of a pharmaceutical and the method used will depend on the physical and chemical characteristics of the sample. Water is present in most naturally occurring soils and has a profound effect in soil behaviour. A calibration and validation set were designed for the conception and evaluation of the method adequacy. Headspace Moisture Analysis for Determination of Residual Moisture Content in Lyophilized Pharmaceutical Products Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination. The dry matter that remains after moisture analysis is commonly referred to as total solids. From the moisture content/r.h. The Importance of Determining Residual Moisture Levels in Your Freeze Dried Sample . From biological research organizations, pharmaceutical manufacturers, to food producers and packers, The results do not contain other volatile matter except the water. equilibrium of a product a ‘safe’ storage moisture content can be stipulated. By Derek Duncan Pharmaceutical Technology 3. It is also used as a subsidiary to almost all other field and laboratory tests of soil. Chemistry. Karl Fischer Titration and Loss–on-Drying are the two most widely used methods in pharma — but both techniques have their limitations. A knowledge of the moisture content is used as a guide to the classification. Water is found in all food products. Too little or too much can affect the physical and chemical properties of food, which directly correlate to freshness and shelf-stability. If water is added to particles such as sand, water coating the grains would tend to bind them together by its surface tension, giving rise to greater internal cohesion, and therefore shear strength. Moisture content determination of pharmaceutical pellets by near infrared spectroscopy: Method development and validation Moisture affects the angle of repose, as anyone who has ever built a sand castle can confirm. Moisture analysis following freeze-drying needs to be fast and accurate, particularly for the often expensive, complex and lengthy procedure of pharma manufacture. Loss on drying (LOD) is determined by heating the sample below its melting point in an oven and it includes all volatile matter including water content and solvents. Moisture content is one of the most commonly measured properties of food materials. Water content can be determined by any one of the following procedures: Loss on drying, for drugs containing no constituents other than water volatile at 105°C; Water content by Karl Fischer (Titrimetric) Mix and accurately weigh the substance to be tested, and, unless otherwise directed in the individual monograph, conduct the determination on 1 to 2 g. Tests can be manually conducted (weigh, oven dry, weigh) or automated (integrated weight and heating unit) with systems called Moisture Determination Balances. Learn how automated water content determination in pharmaceutical manufacturing is possible with volumetric and coloumetric Karl Fisher titration, how the KF oven method excels in cases where direct titration is not possible, and how automated homogenizers enable water determination in tablets. MOISTURE CONTENT DETERMINATION Moisture content analysis is a critical component of material quality and essentially a function of quality control in most production and laboratory facilities. In addition, the oven method requires a separate determination of the yield of essential oil for the calculation of the moisture content. Moisture is an important factor in food quality, preservation, and resistance to deterioration. The determination of moisture content by the solvent method was performed in two hours, while at least 24 hours are necessary using the oven method. 3.1 Introduction. As higher moisture content often correlates with poorer stability, this has resulted in recommendations for low residual moisture content of 0.5-3% w/w [4] and moisture induced instability is particularly an issue when preparing primary biological reference materials as these must maintain their potency for the life of the standard [7] although over-drying may also be deleterious to stability. Water content is used in a wide range of scientific and technical areas and is expressed as a ratio, which can range from 0 (completely dry) to the value of the materials’ porosity at saturation. A systemic approach on understanding the role of moisture in pharmaceutical product degradation and its prevention: challenges and perspectives Sukanta Roy 1 , Sabahuddin Siddique 2 , Shramana Majumder 1 , Mohi Iqbal Mohammed Abdul 3 , Syed Ata Ur Rahman 3 * , Durdana Lateef 4 , Shubhasis Dan 5 and Anirbandeep Bose 5 Water content is determined by the Karl Fischer titration method and it consists of only water i.e moisture content. It is important to food scientists for a number of different reasons: Legal and Labeling Requirements. These initial values were used to … Many industries, including the food, chemical, and pharmaceutical product industries, depend heavily on exact knowledge of the moisture content … Timber is normally kiln dried down to about 8-10% moisture content but it will quickly reabsorb moisture if it’s stored badly. T. A. Oxley, S. W. Pixton, Determination of moisture content in cereals. (Wet-base test) or final weight (Dry-base test) and the moisture content calculated. Depending on the balance and heating mechanism, a wide array of precision and accuracy is available. The water content of medicaments strongly influences their quality, shelf life and stability as well as the release of the active substances. Moisture analysis covers a variety of methods for measuring moisture content in both high level and trace amounts in solids, liquids, or gases. For example, the moisture content can affect the efficiency of achemical reaction or determine the shelf life of pharmaceuticals or foods. Increasingly, industry has become driven by more stringent regulations, where companies are asked to understand specific material properties, of intrinsic value during the design and implementation of an efficient lyophilisation recipe. The determination of water therefore assumes great importance in pharmaceutical analysis. Log in Join now 1. The aim of the present study was to develop and validate a near infrared method able to accurately determine a moisture content of pharmaceutical pellets ranging from 1% to 8% in order to check their moisture content conformity. MOISTURE DETERMINATION TECHNIQUES 1. Figure 7 contains the DVS data from a micronized pharmaceutical material, in which the RH is stepped in increments of 10 % Water content affects the cohesiveness of particles. There are many applications where trace moisture measurements are necessary for manufacturing and process quality assurance. Determination of moisture content also is necessary to calculate the content of other food constituents on a uniform basis (i.e., dry weight basis). Latest Science Discoveries, Reagents Preparations, Standard Laboratory Analysis Procedures and Promoting the importance of Life to the World 3.1 Determination of Moisture Content 3.1.1 General requirements 3.1.1.1 Scope. 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