What is the use of acetic acid in a pharmaceutical company?

Answer 1

One use is described in the following NDC-approved packaging label (NDC # 60432-741-15) for a particular formulation using what is known as "glacial acetic acid": acetic acid (Acetic Acid) solution

[Morton Grove Pharmaceuticals, Inc.]

= DESCRIPTION = Acetic Acid Otic Solution, USP is a nonaqueous solution of glacial acetic acid, USP (2%), in a propylene glycol vehicle containing benzethonium chloride, USP (0.02%); propylene glycol diacetate, NF (3%) and sodium acetate, USP (0.015%). It may also contain citric acid, USP. The molecular formula for acetic acid is CH3COOH, with a molecular weight of 60.05. The structural formula is: Acetic Acid Otic Solution is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal. = CLINICAL PHARMACOLOGY = Acetic acid is anti-bacterial and anti-fungal; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues. = INDICATIONS AND USAGE = For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial. = CONTRAINDICATIONS = Hypersensitivity to Acetic Acid Otic Solution or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal. = WARNINGS = Discontinue promptly if sensitization or irritation occurs. = PRECAUTIONS = Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear. Safety and Effectiveness in pediatric patients below the age of 3 years have not been established. = ADVERSE REACTIONS = Stinging or burning may be noted occasionally; local irritation has occurred very rarely. = DOSAGE AND ADMINISTRATION = Carefully remove all cerumen and debris to allow Acetic Acid Otic Solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with the solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of the solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Acetic Acid Otic Solution 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal. = HOW SUPPLIED = Acetic Acid Otic Solution USP, 2% is supplied in 15 mL measured drop, safety-tip plastic bottles. Store at controlled room temperature, 15 °-30 °C (59 °-86 °F). KEEP CONTAINER TIGHTLY CLOSED Rx Only Product No.: 8741 Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053 A50-8741-15

REV. 3-04 =========================================== The following (apparently rather dated) excerpt from the British Pharmaceutical Codex describes other uses. (The authenticity of the following excerpt, which was found at:

http://www.henriettesherbal.com/eclectic/bpc1911/acidum-acet.html

was not independently researched). Published by direction of the Council of the Pharmaceutical Society of Great Britain, 1911. Related entry: Vinegar - Vinegars

Other tomes: Ellingwood - King's Acetic acid is obtained by the destructive distillation of wood, or by the oxidation of alcohol. It should contain 33 per cent. by weight of real acid, CH3COOH, and may be purified by distilling over potassium permanganate. It occurs as a clear, colourless, pungent liquid, miscible with water and alcohol in all proportions. Specific gravity, 1.044. Acidum Aceticum, U.S.P., contains 36 per cent. by weight of absolute acetic acid, and has a specific gravity of 1.045 at 25°. Action and Uses.-Acetic acid is oxidised in the body and is excreted in the urine as carbonate; it is, therefore, mildly diaphoretic, diuretic, and expectorant. It is administered in mixtures in the form of the diluted acid, or as oxymel, or oxymel of squill. Applied externally, it has an irritant action, and it is therefore used in liniments. The well-diluted acid is employed as a gargle (1 in 30). Acidum Aceticum Dilutum is used to sponge the skin in fevers, and as a lotion for the scalp. Acetic acid has been employed as a menstruum for making non-alcoholic preparations resembling tinctures. It is an efficient agent for the exhaustion of many drugs, and preparations made in this way are known as "acetracts"; their acidity and sour flavour are, in some instances, objections to their use. Acetic acid is incompatible with alkali salts, hydroxides, carbonates, bicarbonates, salicylates, and benzoates. ; Acetum Odoratum, B.P.C.-TOILET VINEGAR. : Acetic acid (1 in 8), with odorants. Used as a deodorant by sprinkling about the sick room; it is mixed with water for washing in the bath or hand-basin; a few drops are inhaled from the handkerchief as a restorative, or applied to the forehead to relieve headache. ; Acidum Aceticum Dilutum, B.P.-DILUTED ACETIC ACID. : Acetic acid (33 per cent.), 12.5; distilled water, sufficient to produce 100. ; Acidum Aceticum Dilutum, U.S.P.-DILUTED ACETIC ACID, U.S.P. : Acetic acid (36 per cent.), by weight, 20; distilled water, 100. C2H4O2 = 60.032. Glacial acetic acid may be obtained by the distillation of dried sodium or calcium acetate with strong sulphuric acid. It should contain 99 per cent. by weight of real acid, CH3COOH. The acid is also official in the U.S.P. It occurs as a clear colourless liquid, or colourless, crystalline mass, with a strong pungent odour. It is crystalline at low temperatures, and the crystals melt again at about 14.8°. A variety of glacial acetic acid is in commerce, melting at 10°. The official melting-point for glacial acetic acid (15.5°) corresponds to a stronger acid than 99 per cent. Specific gravity, 1.058 (about 1.049 at 25°), increased by the addition of 10 per cent. of water. Boiling-point not less than 117°. Action and Uses.-Glacial acetic acid is a rubefacient, vesicant, or caustic, according to the length of time it is in contact with the skin. Its use requires caution, owing to its tendency to spread. It is chiefly employed as a mild caustic for destroying warts, corns, etc. When inhaled by the nostrils, glacial acetic acid induces a reflex stimulation of the medullary centres. It is therefore employed in this manner as a restorative and stimulant in cases of fainting. In cases of poisoning by glacial acetic acid large draughts of water containing soap, washing soda, magnesia, or chalk, and oil, or gruel should be given. ; Acidum Aceticum Aromaticum, B.P.C.-AROMATIC ACETIC ACID. Syn.-Aromatic Vinegar. : Glacial acetic acid, with odorants. Employed as a restorative by inhaling from a small saturated sponge contained in a vinaigrette. It should be distinguished from toilet vinegar (see Acetum Odoratum).