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Aluminum monostearate
آلومینیوم مونواستئارات
1Nonproprietary names
- USP–NFAluminum Monostearate
2Synonyms and trade names
Aluminium monostearate; aluminium hydroxide stearate; dihydroxy(octadecanoato)aluminium; aluminum stearate (mono)
3Chemical name and CAS Registry Number
Dihydroxy(octadecanoato-O)aluminium · [7047-84-9]
UNII P9BC99461E · PubChem CID 10246924
4Empirical formula and molecular weight
C18H37AlO4 · 344.47
5Functional category
Gelling agent, viscosity modifier
Typical concentrations: — · Dosage forms: Semi-solid
6Applications in pharmaceutical formulation
Used as a gelling and thickening agent for oils, notably to give thixotropic, slowly dispersing oily vehicles for depot intramuscular suspensions, and as a stabiliser and thickener in ointments, creams and cosmetics. It also acts as a water-repellent and emulsion stabiliser.
7Description
A fine, white to yellowish-white, bulky powder with a faint, characteristic odour. It is a compound of aluminium with a mixture of solid organic acids from fats, mainly stearic and palmitic acids.
8Typical properties
- Composition
- aluminium compound of stearic and palmitic acids, consisting mainly of the monostearate
- Solubility
- practically insoluble in water, ethanol and ether; forms gels when heated with fixed oils or aromatic hydrocarbons
- Appearance
- fine, bulky white to yellowish-white powder
9Stability and storage conditions
Stable. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Incompatible with strong acids, which liberate the fatty acids, and with strong oxidising agents.
11Method of manufacture
Prepared by reacting a soluble aluminium salt with sodium stearate (or a sodium soap of mixed stearic and palmitic acids) in aqueous solution under controlled conditions, followed by washing and drying of the precipitate.
12Safety
Regarded as of low toxicity and non-irritant at the levels used in topical and depot preparations. As with other aluminium compounds, the total aluminium load should be considered in products for patients with renal impairment.
13Handling precautions
Observe normal precautions for the quantity handled. Avoid dust formation; eye protection and a dust mask are recommended.
14Regulatory status
Included in the USP–NF. Used in topical preparations and in oily intramuscular depot suspensions.
15Related substances
Aluminium distearate; aluminium tristearate; calcium stearate; magnesium stearate; zinc stearate.
16Comments
To form an oil gel the powder is dispersed in the oil and heated (typically above about 120 °C) until it dissolves, then cooled; the final viscosity depends strongly on heating temperature, time and cooling rate, so these must be standardised.