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Excipient monograph · مونوگراف ماده جانبی
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Palmitic acid
اسید پالمیتیک
1Nonproprietary names
- USP–NFPalmitic Acid
2Synonyms and trade names
Hexadecanoic acid; cetylic acid; n-hexadecoic acid; 1-pentadecanecarboxylic acid
3Chemical name and CAS Registry Number
Hexadecanoic acid · [57-10-3]
UNII 2V16EO95H1 · PubChem CID 985
4Empirical formula and molecular weight
C16H32O2 · 256.42
5Functional category
Lubricant
Typical concentrations: — · Dosage forms: Solid
6Applications in pharmaceutical formulation
Used as a lubricant and as an emulsifying agent (after neutralisation to soaps) in topical and oral products, as a lipid component of solid lipid nanoparticles and other lipid carriers, and as a constituent of many fatty-acid mixtures, notably pharmacopoeial stearic acid. It is also used in cosmetics and foods.
7Description
Hard, white or faintly yellowish, slightly glossy crystalline solid, flakes or powder with a slight characteristic odour. It is the most common saturated fatty acid in animal and plant fats.
8Typical properties
- Melting point
- about 60–63 °C (high-purity material ≈ 63 °C)
- Acid value
- ≈ 219 (theoretical for the pure acid)
- Solubility
- practically insoluble in water; soluble in hot ethanol, ether and chloroform; slightly soluble in cold ethanol
- pKa
- ≈ 4.8 (in dilute solution; apparent value in lipid assemblies is higher)
9Stability and storage conditions
Stable; as a saturated fatty acid it is resistant to oxidation. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Incompatible with strong oxidising agents and bases (with which it forms soaps); it may react with basic drugs and with metal salts.
11Method of manufacture
Obtained by hydrolysis of fats such as palm oil, followed by separation of the fatty acids by fractional distillation and/or crystallisation.
12Safety
A normal dietary component; regarded as non-toxic and only mildly irritant at the levels used as an excipient.
13Handling precautions
Observe normal precautions for the quantity handled. Avoid generating dust; eye protection, gloves and a dust mask are recommended.
14Regulatory status
Described in the USP–NF. Fatty acids are permitted as food additives in the USA under specified conditions (21 CFR 172.860).
15Related substances
Stearic acid; myristic acid; cetyl palmitate; glyceryl palmitostearate; isopropyl palmitate.
16Comments
Commercial palmitic acid is often supplied as blends with stearic acid; the ratio of the two acids affects melting behaviour and lubricant or emulsifying performance, so the grade composition should be specified.