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Excipient monograph · مونوگراف ماده جانبی
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Ammonium chloride
آمونیوم کلراید
1Nonproprietary names
- BPAmmonium Chloride
- Ph. Eur.Ammonium Chloride
- USP–NFAmmonium Chloride
2Synonyms and trade names
Ammonii chloridum; ammonium muriate; sal ammoniac; salmiac; E510
3Chemical name and CAS Registry Number
Ammonium chloride · [12125-02-9]
UNII 01Q9PC255D · PubChem CID 25517
4Empirical formula and molecular weight
NH4Cl · 53.49
5Functional category
pH adjuster, buffering agent
Typical concentrations: — · Dosage forms: Liquid
6Applications in pharmaceutical formulation
Used as an acidifying agent and, with ammonia, as an ammonia–ammonium chloride buffer, and in some oral expectorant and cough preparations, where it is also an active ingredient. In foods it is used as a flavouring (for example in salty liquorice) and as a yeast nutrient and dough conditioner.
7Description
Colourless crystals or a white, odourless, crystalline powder with a cool, saline taste.
8Typical properties
- Behaviour on heating
- sublimes at about 340 °C without melting, dissociating into ammonia and hydrogen chloride
- Density
- ≈ 1.53 g/cm³
- pH
- about 4.5–6 (5% w/v aqueous solution)
- Solubility
- freely soluble in water (about 37 g per 100 g water at 20 °C), more soluble in hot water; sparingly soluble in ethanol; soluble in glycerol
- Hygroscopicity
- slightly hygroscopic
9Stability and storage conditions
Stable, but slightly hygroscopic and may cake. Store in an airtight container in a cool, dry place.
10Incompatibilities
Liberates ammonia with alkalis and alkali carbonates. Incompatible with silver and lead salts, with strong oxidising agents such as potassium chlorate, and with nitrites; it can corrode metals in the presence of moisture.
11Method of manufacture
Made by neutralising ammonia with hydrochloric acid, or recovered as a by-product of the ammonia–soda (Solvay) process, then purified by crystallisation.
12Safety
At the levels used as an excipient it is of little concern. Large oral doses cause gastric irritation, nausea and vomiting and can produce metabolic acidosis; it should be avoided in patients with impaired hepatic or renal function.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and gloves are recommended; heating releases irritant fumes of ammonia and hydrogen chloride.
14Regulatory status
GRAS listed. Accepted as a food additive in Europe (E510). Used in oral medicines licensed in Europe.
15Related substances
Ammonia solution; ammonium carbonate; potassium chloride; sodium chloride.
16Comments
Ammonium chloride dissolves endothermically, so solutions cool noticeably as it dissolves. Its acidifying effect in the body comes from conversion of the ammonium ion to urea in the liver, which is why hepatic impairment is a contraindication at therapeutic doses.