Identification b acid value correct the coefficient from 5. Stearic acid stearic acid, also known as noctadecanoic acid c18h36o2, is a saturated, waxlike, fatty acid commonly used in the production of pharmaceutical tablets and capsules. Effect of stearic acid level on the physical properties of. Palmitic acid was presented in a gras monograph on sodium oleate and. Palmitic acid, myristic acid, oleic acid, stearic acid were purchased. Import permit license may be needed in your country. The aim of this study was to investigate the effect of stearic acid on markers of hepatocyte transplantation in rats with acetaminophen induced liver damage. Analysis of stearic acid under the condition of japanese pharmacopoeia 16 category document no. This material, like most materials in powder form is capable of creating a dust explosion. When the surface is entirely covered, additional drops of the stearic acid hexane solution will cause the stearic acid to pile up and you will see a visible trace of the acid on the surface. Purified stearic acid is manufactured from fats and oils derived from edible sources and is a mixture of stearic acid c 18 h 36 o 2 and palmitic acid c 16 h 32 o 2, which together constitute not less than 96.
Having reached stage 6 of the pdg process, the stearic acid monograph has been formally approved by the usp monographsexcipients expert committee in accordance with the rules and procedures of the 20102015 council of experts. Development and validation of a gcfid method for quantitative. Expl ther stearic acid is known as a potent antiinflammatory lipid. Constituents fixed oil containing esters of linoleic, palmitic, oleic acids. Select all reagents to have as low a content of cadmium, lead, and nickel as practicable, and assay store all reagent solutions in containers of. Ga251 analysis of stearic acidunder the condition of.
Stearic acid united states pharmacopeia usp reference standard synonym. Stage 6 harmonization official may 1, 2012 stearic 1. Stearic acid stearic acid functions as an anionic oilinwater emulsifier. High performance liquid chromatography determination of fatty. A revision to the harmonized standard for stearic acid has been approved by the pharmacopeial discussion group pdg as described in its pdg stage 6 rev. Composition of fatty acids by gc european pharmacopoeia 6. Pdf dexamethasone is a type of steroid medication having. Oleic acid, european pharmacopoeia ep reference standard. First step analysis in quality control volumetric analysis.
The enigma of the first arabic book printed from movable type pdf. Magnesium stearate food and agriculture organization. Title the title of the book is ayurvedic pharmacopoeia of. Using the results of the above four determinations, add together the percentages of free stearic acid, erythromycin stearate, sodium stearate all calculated with reference to the undried substance and the water content. System suitability solution transfer about 50 mg each of usp stearic acid rs and usp palmitic acid rs to a small conical flask fitted with a suitable reflux condenser. View our uptodate catalogue and place your bpcrs orders here. L is the magnitude of a typical length dimension and k, n, are constants. The stereospecific conversion of stearic acid to oleic acid george j.
Isostearic acid is a fatty acid molecule with an 18carbon atom chain backbone. Each pharmacopoeia will adapt the text to take account of local reference materials and reagent specifications. Stearic acid european pharmacopoeia ep reference standard. The plant materials were collected and conserved chemicals and reagents. Stearic acid is a saturated monobasic acid with 18 carbonchain lengths. A pharmacopoeia, pharmacopeia, or pharmacopoea in its modern technical sense, is a book. European pharmacopoeia, fourth edition 2002 012002. The both treatments performed separately with acid or stearic acid, are efficient and favor the dispersion since the highest viscosity is obtained for the compounds based on acid or stearic acid treated graphite. Flowability of powder mix was 15 mm flodex, which is good. It is widely used in personal care products such as soaps, creams, lotions. All structured data from the file and property namespaces is available under the creative commons cc0 license. The fatty acid fraction of the substance has the following composition. The stearic acid monograph will be incorporated into and become official with usp 35nf 30. Next, the mixture was cooled to room temperature, and an appropriate amount of the polysorbate 80 aqueous solution.
Palmitic acid shows a similar ir spectrum to stearic acid, with the characteristic peak at around 1700 cm. Stearic acid united states pharmacopeia usp reference. Stearic acid sa is a hydrophobic compound widely used in the manufacture of solid dosage forms as a tablet and capsule lubrificant, binder, or sustained release excipient. How to prepare the solution of palmitic acid or stearic acid. Interaction of the acid soap of triethanolamine stearate and. Pdf formulation and evaluation of dexamethasone loaded stearic. Stearic acid is manufactured from fats and oils derived from edible sources and is a mixture of stearic acid c 18 h 36 o 2 and palmitic acid c 16 h 32 o 2. Assay place about 100 mg of stearic acid in a small conical flask fitted with a suitable reflux attachment. The international pharmacopoeia world health organization.
Chart of saponification values for making soap lye sodium. It is made by extraction from animal or vegetable fats and oils. Oleic acid is an octadec9enoic acid in which the double bond at c9 has z cis stereochemistry. Ga251 analysis of stearic acid under the condition of japanese pharmacopoeia 16. Place about 50 mg of usp stearic acid rs and about 50 mg of usp palmitic acid rs in a similar flask. Stearic acid is used majority in the activator system of the rubber compounding and more specific for the curing systems based on sulfur, in the activatoraccelerator network. Our stearic acid is from vegetable origins palm and is manufactured and designed to blend well with your cosmetic recipes. Effect of diets rich in oleic acid, stearic acid and linoleic acid on postprandial haemostatic factors in young healthy men. Handbook of pharmaceutical excipients second edition edited by ainley wade and paul j weller. In pharmaceutical dosage forms, stearic acid is used as an emulsifying agent, solubilizing agent, tablet and capsule lubricant. In this study, stearic acid was incorporated into microcrystalline cellulose mcc pellets produced by the extrusionspheronization technique in order to improve.
Files are available under licenses specified on their description page. The structural evolution of the resultant sample during storage was characterized by using light microscopy, cryosem, differential scanning calorimetery, ph, infrared spectroscopy, elemental analysis, and simultaneous small and wideangle x. Summary sucrose monoesters of lauric, palmitic or stearic acid consist mainly of sucrose monoesters of individual fatty acids, namely lauric, palmitic or stearic acid with smaller amounts of the diesters. In vitro dissolution study was performed using the usp type ii. The drying power of an oil is in relation to its chemical composition. In contrast to stearic acid, calcium and magnesium stearates were found to be hygroscopic compounds which were able to absorb moisture in conditions of elevated air moisture content, this water being present in. Place 100 mg of stearic acid in a small conical flask. These theories depend upon the basic assumption that the energy required to produce a change dl in a particle of a typical size dimension l is a simple power function of l. Methadone concentrate for oral solution folic acid. Oleic acid c18h34o2 cid 445639 structure, chemical names, physical and chemical properties, classification, patents, literature. Wistar rats were randomly assigned to 10day treatment. European pharmacopoeia signature name date \ t l 1. Stearic acid is commonly used to emulsify lotions made from scratch. Calcium stearate consists of calcium salts mainly of stearic acid and palmitic acid in variable proportions.
Take 5 ml of a 1% wv solution of nonadecanoic acid internal standard in toluene to a mixture of 50 mg of stearic acid wrs and 50mg of palmitic acid wrs and evaporate to dryness. United state pharmacopeia usp36nf31 requires the identification and quantitation of oleic acid and related fatty acids in oleic acid uspnf material 2. Preparation of pellets containing em by extrusionspheronization. Stearic acid had a total of 23 reported uses in 2006. Stearic acid definition of stearic acid by medical dictionary. It can also be used in candle manufacturing to raise the melt point and improve the hardness of candle wax along with countless other applications. Delay effect of magnesium stearate on tablet dissolution. Stearic acid uses, dmf, dossier, manufacturer, supplier. Stearic acid correction to the signoff signed on november 20 item to be corrected. The stereospecific conversion of stearic acid to oleic acid. The specificity of stearateinduced apoptosis for cancerous versus noncancerous breast cells has not been examined and the mechanism underlying stearateinduced apoptosis is.
Stearic acid is naturally present in many foods in far greater quantities than in supplements. Solubility of stearic acid in various organic solvents and its prediction using non ideal solution models. Stearic acid 10% or 20%, ww was melted and then poured into the heated mixture and homogenized with a pestle. Stearic acid is a white, waxy, natural acid found in animal and vegetable fats. Stearic acid is also the immediate precursor of oleic acid, an important fatty acid found in healthy olive oil.
Portions of this monograph that are national usp text, and. The stearic acid monograph that was posted on april 24, 2015 had an incorrect official date of may 1, 2015, instead of may 1, 2016. It is a waxy solid and its chemical formula is c 17 h 35 co 2 h. Heavy metals, residue on ignition, container and storage, i freezing point alternative apparatus usp. Add 5 ml of boron trifluoride solution and complete the procedure described for the solution 1 beginning with the words heat under. Notice of adoption of harmonized standard posting date. Pdf solubility of stearic acid in various organic solvents. Wear self contained breathing apparatus and protective clothing to prevent contact with skin and eyes.
The clean sample should be soaked in ethanolic stearic acid solution 0. Stearic acid and triethanolamine tea in a molar ratio of 2. In the physical characters it has the color, physical state and odour. Apr 29, 2011 added labeling requirement to state the type of stearic acid.
This acid is insoluble in water and soluble in ethanol. Most important symptoms and effects, both acute and delayed. It is an isomer of stearic acid, meaning that they both have a chemical formula of c 18 h 36 o 2, but differ in the arrangement of their atoms. Commercial stearic acid is a mixture of stearic acid with palmitic and myristic acid. The fatty acids generally found are monounsaturated, such as oleic acid 18. Now uses stearic acid and magnesium stearate that are sourced from vegetable oils obtained from palm and other.
Purification of fatty acids is mainly achieved by distillation, which makes use of the differences in boiling points between the desired fatty acids and the impurities, to effect a separation of the two species. Ep a revision to the harmonized standard for stearic acid has been approved by the pharmacopeial discussion group pdg as described in its pdg stage 6 rev. Our stearic acid is triple pressed palm stearic acid. Slnps with stearic acid as solid lipid, lutrol f68 as surfactant and tween80 as stabilizer.
Palmitic acid, olic acid, myristic acid, stearic acid fatty acid analysis by hplc using pda detector material and method. Effect of stearic acid on enalapril stability and dissolution. This fatty acid has profound and diverse effects on liver metabolism. The distillation is usually conducted at reduced pressure to save energy and is done in such a way that the fatty acids are. Pharma pdf downloads pharma pdf downloads pharma pdf downloads pharma pdf downloads pharma pdf downloads. Stearic acid stearyl alcohol sucrose compressible sugar confectioners sugar sugar spheres. It describes complete drug profiles with their structures, iupac name, physical and chemical characters.
Stearic acid stearate is an 18carbon saturated fatty acid that has been shown to inhibit invasion and proliferation and induce apoptosis in various human cell types. This page was last edited on 11 september 2018, at 11. Effect of stearic acid level on abrasion resistance. Stearic acid is a saturated fatty acid that can deposit on the surface in special conditions. Having reached stage 6 of the pdg process, the stearic acid monograph has been formally approved by the usp monographsexcipients expert committee in accordance with the rules and procedures of the. Stearic acid european pharmacopoeia ep reference standard synonym. The highest quality reference standards for reliable results. Stearic acid 2236 was placed on top of the mixture of api, avicel ph102, starch 1500, and tablettose 80, and mixed in collette150 mixeri, 150 rpm for 45 s.
Stearic acid ple solution g n normality of the potassium hydroxide solution portions of this monograph that are national usp text, and are 56. Place the respond to those of the system suitability solution, as ob bomb in a hood, and open carefully because corrosive tained in the test for relative content of stearic acid and gases may be expelled. On of the most important book is british pharmacopoeia. These small pastilles are ideal as an emulsifying agent in creams, lotions, deodorants, and most natural body care recipes. Discussion the formulation recipe for the seven variations of stearic acid levels is presented in table 1, while table 2 shows the mixing schedule adopted. Studies of moisture exchange between stearic acid, calcium. The indian pharmacopoeia is the legally recognized book of standards for the. Stearic acid revision of the signoff cover sheet of revision 1 correction 1 signed on nov. Appearance reagents and reference materials each pharmacopoeia will adapt the text to take account of local reference. Stearate preferentially induces apoptosis in human breast.
Wear selfcontained breathing apparatus and protective clothing to prevent contact with skin and eyes. Stearic acid inside view stearic acid are the fatty acids with long molecules of hydrocarbon chains with carboxylic acid at the end group. Stearic acid acidum stearicum definition mixture consisting mainly of stearic octadecanoic acid c18h36o2. In nature stearic acid occurs primarily as a mixed triglyceride, or fat, with other longchain acids and as an ester of a fatty alcohol. Finally, but very importantly, the level of unsaturation can be modified or eliminated from a mixture by hydrogenation reaction with hydrogen to add the missing hydrogen back into the double bonds in the material. The diluted aliquots were then analyzed by gas chromatography. Characters a matt, white to slightly yellowish, very fine powder which creaks when, pressed between the fingers. Moisture content, hygroscopicity, and thermal desorption parameters of stearic acid, calcium stearate, and magnesium stearate, which are used as excipients for tableting, were studied. The copper substrate should be cleaned, pickled, and soaked in 10% volume hno 3 for oxide elimination. The european pharmaco acid methyl esters, which corresponds to the composition of poeia draft was based in part on comments from the japanese the substance to be examined.
Stage 6 harmonization official may 1, 2012 stearic 1 m amount of stearic acid taken to prepare the sam. That will be the signal to stop adding drops of solution. We use cookies to ensure that we give you the best experience of our website. Stearic acid stearic acid is one of the most common longchain fatty acids, found in combined form in vegetable fats. S number 557040 magnesium stearate, 91031639 fatty acids c1618 magnesium salts chemical formula mgc 18h 35o 2 2 magnesium distearate formula weight 591. If the suffix psy, narc or drug precursor, or motbiotox appears, export authorizations are mandatory in france or according to european regulations. The solubility of palmitic acid in water is as low as that of stearic acid, and this may cause the delay of tablet dissolution in the same way. Definition magnesium stearate is a mixture of magnesium salts of different fatty acids consisting mainly of stearic octadecanoic acid c17h35coo2mg and palmitic hexadecanoic acid c15h31coo2 mg with minor proportions of other fatty acids. It is synthesized by the hydrolysis of animal fat or from hydrogenation of cottonseed or vegetable oil. Charactersdescription, nickel, labelling source of stearic acid.
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