Ascorbic acid functions as an enzymatic cofactor for multiple enzymes, serving as an electron donor for monooxygenases and dioxygenases. It is well known that ascorbic acid is a sensitive and thermolabile compound, so its extraction with high yield and without any decomposition has been a matter of difficulty and laborintensive for the analysts. The drug may also be useful to treat idiopathic methemoglobinemia, although it is less effective than methylene blue. Intravenous ascorbic acid vitamin c has emerged as a potential treatment for sepsis. Ascorbic acid injection is indicated for the treatment of. It is an ingredient of antiaging cosmetic products alone or along with alphatocopherol vitamin e. Ascorbic acid drug information, uses, side effects. Ascorbic acid injection, usp vitamin c no preservative added. We identified 3 previous stability studies of ascorbic acid solutions in iv fluids 7, 10,11. Highdose vitamin c injection to cancer patients may promote. Historically, doctors prescribed vitamin c or vitamin crich foods to treat scurvy, a medical condition caused by extremely low levels of. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda.
Vitamin c ascorbic acid is a weak organic acid which is used as an acidifier. In this work, a flow injection analysis method with amperometric detection was developed using a rgobased sensor to determine ascorbic acid in real food beverage samples. While particular formulations of vitamin c tablets may differ slightly among competing manufacturers, the primary ingredient should be raw ascorbic acid. Direct analysis of ascorbic acid in food beverage samples. Jan 01, 2010 gt formulation with ascorbic acid was observed to directly influence retention of catechins by caco2 monolayers. The expiry date of intravenous medications following reconstitution or dilution is often limited to. Pdf formulation and evaluation of ascorbic acid tablets. Specialised references should be consulted for specific information on laboratory test interferences caused by ascorbic acid. Ascor ascorbic acid injection comes in different strengths and amounts.
It is a white solid, but impure samples can appear yellowish. Ascorbic acid injection lmder section 505b 2 of the federal food, dmg, and cosmetic act. Cyanocobalamin the instability of cyanocobalamin in aqueous solution is mainly due to dehydro ascorbic acid which is the decomposition product of ascorbic acid. Formulation and evaluation of ascorbic acid tablets by direct compression using microcrystalline starch as a direct compression excipient article pdf available september 2011 with 5,695 reads. New zealand datasheet 1 product name 2 qualitative. Abstract ascorbic acid vitamin c is extensively used in a variety of formulations including creams. Cyanocobalamin is alone stable even when exposed to light. Notably, recent studies revealed that excessive vitamin c. Ascorbic acid has been associated with development of acute or chronic oxalate nephropathy following prolonged use of high doses of ascorbic acid infusion. Do all ascorbic acid injections have the same formulation and are they made using the same process.
We can supply ascorbic acid vitamin c 25% injection. Dec 23, 2019 the chemical name of ascorbic acid is l ascorbic acid. Medscape indicationspecific dosing for cenolate, vitamin c ascorbic acid. Questions and answers january 2011 acidifier vitamin c ascorbic acid and injection drug use. It occurs as a white or slightly yellow crystal or powder with a slight. Ascorbic acid impurities pharmaceutical impurities. Protocol for the use of vitamins c in the treatment of cancer. Bleomycin is inactivated in vitro by ascorbic acid. Ascorbic acid may be useful in correcting tyrosinemia in premature infants on highprotein diets. Hemolysis has been reported in patients with glucose6phosphatase dehydrogenase g6pd deficiency and the risk for severe hemolysis may be increased during ascorbic acid therapy. Two sample preparation methods for extracting ascorbic acid in dog rose fruit were evaluated. Large doses may cause gastrointestinal disorders including diarrhoea. Formulation and evaluation of a vitamin c multiple emulsion. Effects of ascorbic acid injection in incubated eggs submitted to.
Ascorbic acid injection is unlikely to affect the patients ability to drive or use machinery. You will need to talk about the benefits and risks of using ascorbic acid vitamin c injection while you are pregnant. Ascorbic acid injection is a sterile solution, in water for injection, of ascorbic acid prepared with the aid of sodium hydroxide, sodium carbonate, or sodium bicarbonate. Sponsor regarding the ascorbic acid injection development program for the. Drug nanoparticle formulation using ascorbic acid derivatives and its therapeutic uses have recently been introduced. Vitamin c ascorbic acid injection provides vitamin c supplementation. Vitamin c, also known as ascorbic acid and ascorbate, is a vitamin found in various foods and sold as a dietary supplement.
Pdf formulation and stability of ascorbic acid in topical. The effects of co formulation of these watersoluble forms of vitamin c with ascorbyl palmitate p a lipophilic form of vitamin c and dehydroascorbic acid. Merits proprietary lines include merit mega c iv ascorbic acid usp injection, b plex 100 injection, chloromag magnesium chloride usp injection, and iso485, fda registered facilities for devices. Ascorbic acid g sterile water ringers lactate ascorbic acid when employed beyond the range of a vitamin in 1 250 250 human pathology. It assists in the prevention of blood clotting and bruising, and strengthens capillary walls. Product and company information luitpold pharmaceuticals, inc.
Ascorbic acid mitigates dgalactoseinduced brain aging by. It is a potent antioxidant and skinsoothing agent that can improve the appearance of signs of aging. Instability problems such as oxidation susceptibility have made incorporating vitamin c in topical formulations a challenging issue. Administration of intravenous ascorbic acidpractical. Some ascorbic acid is metabolised to inactive compounds including ascorbic acid2sulfate and oxalic acid mcevoy, 1993. Ascorbic acid is a strong reducing agent and interferes with numerous laboratory tests based on oxidation reduction reactions. Large doses may also result in hyperoxaluria and renal oxalate calculi may form if the urine becomes acidic. Extended stability of ascorbic acid in 5% dextrose injection and 0.
Ascorbic acid may cause acidification of the urine and result in decreased amphetamine serum levels and affect excretion and plasma concentrations of other drugs sensitive to urine ph. Ascorbic acid may decrease the activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Ascorbic acid is often used as an antioxidant in food preservation, meat products, fermented flour products, beer, tea, fruit juices, canned fruit, and canned meat. Ascorbic acid injection is a clear, colorless to slightly yellow sterile solution of ascorbic acid in water for. In this work it has been tried to extract ascorbic acid in a way that the obtained recoveries will be as much as possible. For mds only preparation of sodium ascorbate for iv and im use robert f. Ascorbic acid is a potent reducing and antioxidant agent that functions in fighting bacterial infections, in detoxifying reactions, and in the.
Ascorbic acid, dissolved in water, degraded completely within 4 h at room temperature, whereas. It comes as a white powder that can be dissolved in water to form a mild acidic solution. Vitamin c is a nutrient also known as ascorbic acid. The natural history of ascorbic acid in the evolution of the mammals and primates and its significance for present day man irwin stone. For standard solution mass ascorbic acid mole iodine. Ascor ascorbic acid injection, for intravenous use. Direct analysis of ascorbic acid in food beverage samples by. Feb 26, 2020 do not take ascorbic acid vitamin c injection for longer than you were told by your doctor. In solutions and creams, ascorbic acid is susceptible to air and light and undergoes oxidative degradation to dehydroascorbic. Patients with diabetes mellitus should not take excessive doses for extended periods of time. It is necessary for the system suitability to satisfy tailing factor of. Cenolate, vitamin c ascorbic acid dosing, indications, interactions.
Ascorbic acid also promotes healthy cell development, proper calcium absorption, and normal cell growth and repair. Ascorbic acid e300 can also be used as a nutritional supplement. Hemolysis has been reported in patients with glucose6phosphatase dehydrogenase g6pd deficiency and the risk for severe hemolysis may be increased during ascorbic acid. Sodium hydroxide andor hydrochloric acid may have been used to adjust ph. Stability studies of a mixture of paracetamol and ascorbic. Highdose vitamin c injection to cancer patients may. Ascorbic acid, tested under the same conditions as the commercial product, was unstable in aqueous solutions, with a degradation rate of 1. The effects of co formulation of these watersoluble forms of vitamin c with ascorbyl palmitate p a lipophilic form of vitamin c and dehydroascorbic acid dhaa, a degradation product on moisture. Do not take ascorbic acid vitamin c injection for longer than you were told by your doctor. Pure ascorbic acid powder water soluble vitamin c powder, 1 kg 2. Find patient medical information for ascorbic acid vitamin c injection on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings.
Is there any way the beyond use date can be extended. The molecular formula is c 6 h 8 0 6 and the molecular weight is 176. Due to its effects on collagen biosynthesis, it is considered as moisturizing and antiaging active ingredient. Ascor is vitamin c indicated for the short term up to 1 week treatment. Vitamin c is essential to normal joint cartilage maintenance and repair. Dec 21, 2016 ascorbic acid injection is a clear, colorless to slightly yellow sterile solution of ascorbic acid in water for injection, for intravenous, intramuscular or subcutaneous use. Ascorbic acid injection fda prescribing information, side.
Ascorbic acid administration in the treatment of anemia in chronic hemodialysed patients fevitc the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Irwin stone is a chemical engineer by training, a biochemist by vocation and a paleopathologist by avocation. Ascorbic acid is an organic compound with formula c 6 h 8 o 6, originally called hexuronic acid. Ascorbic acid aa, vitamin c has shown dosedependent positive effects on hatchability and hatchling body. The prepared formulations were packed in air tight containers. Ascorbic acid administration in the treatment of anemia in. The stability of folic acid is greatly affected by atmospheric oxygen, light, ph and temperature. Agilent application solution analysis of ascorbic acid. Clinical pharmacology in humans, an exogenous source of ascorbic acid is required for. These methods used high performance of liquid chromatography hplc for detecting of ascorbic acid.
Ascor ascorbic acid injection dosage and administration. Ascorbic acid injection is a clear, colorless to slightly yellow sterile solution of ascorbic acid in water for injection, for intravenous, intramuscular or subcutaneous use. The chemical name of ascorbic acid is l ascorbic acid. Freshly prepared formulation was delivered to patients every week. Ascor ascorbic acid injection, usp, 500mgml, 50ml vial.
Ascorbic acidalso known as lascorbic acidhas the most research of any form of vitamin c when it comes to benefits for skin. Ascor is not indicated for treatment of vitamin c deficiency that is not associated with signs and symptoms of scurvy. After oneweek acclimation to the condition of housing facilities, the animals were divided into the following four groups. The primary objective of this study was to evaluate the stability and physical compatibility of 37, 40, 77 and 92 mgml solutions of aa injection following dilution in. In addition to drug solubilization, drug nanoparticle formation was observed using ascorbyl glycoside. Hydrophilic ascorbic acid derivatives such as ascorbyl glycoside have been used not only as antioxidants but also as food and pharmaceutical excipients. Tell your doctor if you are pregnant or plan on getting pregnant. Ascorbic acid is an essential watersoluble vitamin. Ascorbic acid has been used as a urinary acidifier although its efficacy has been questioned. Suitability suitable for use with biological fluids, food samples, and growth media. Ascorbicacid injection was performed before eggs were incubated.
Assessing stability of intravenous ascorbic acid aa over time is important for the feasibility of ongoing randomized trials and also for other clinical applications, such as cancer care. Ascorbic acid injection ascorbic acid injection is a sterile solution, in water for injection, of ascorbic acid prepared with the aid of sodium hydroxide, sodium carbonate, or sodium bicarbonate. Extraction and quantitative determination of ascorbic acid. Figure 1 shows the chromatogram of ascorbic acid, citric acid, and.
Formulation with ascorbic acid and sucrose modulates catechin. Ascorbic acid also functions as a powerful antioxidant, particularly in regards to reactive oxygen species. Vitamin c ascorbic acid has been widely used in formulations of skin care products. Assessing stability of intravenous ascorbic acid aa over time is important for.
Analysis of ascorbic acid injection according to usp method dm614 according to usp 40 method, ascorbic acid should be analyzed using a column packed with l39. Ascorbic acid is a natural water soluble vitamin vitamin c. Phr1709 ascorbic acid impurity d pharmaceutical secondary standard. Pdf formulation and evaluation of ascorbic acid tablets by. Analysis of ascorbic acid injection according to usp method. It dissolves well in water to give mildly acidic solutions. Learn more about vitamin c ascorbic acid uses, effectiveness, possible side effects, interactions, dosage, user ratings and products that contain vitamin c. Ascor ascorbic acid injection, usp mcguff pharmaceuticals, inc. This study suggests that any of the vials can be used in this analysis. Ascorbic acid injection is a clear, colorless to slightly yellow sterile solution of ascorbic acid in water for injection. The natural history of ascorbic acid in the evolution of the. Request pdf extended stability of ascorbic acid in 5% dextrose injection and 0. You will need to talk about the benefits and risks of using ascorbic acid vitamin c injection.
The sensor presented a 2fold gain of analytical signal as well as peak potential displacement, characterizing the electrocatalytic effect of rgo. Drug nanoparticle formulation using ascorbic acid derivatives. Ascorbic acid injection 500mg5ml summary of product. It is a mild reducing agent ascorbic acid exists as two enantiomers mirrorimage isomers, commonly denoted l for levo and d for dextro. When the body is saturated with ascorbic acid and blood. Ascorbic acid injection fda prescribing information.
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