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Boric acid
اسید بوریک
1Nonproprietary names
- BPBoric Acid
- JPBoric Acid
- Ph. Eur.Boric Acid
- USP–NFBoric Acid
2Synonyms and trade names
Acidum boricum; boracic acid; orthoboric acid; trihydroxyborane; E284
3Chemical name and CAS Registry Number
Orthoboric acid · [10043-35-3]
UNII R57ZHV85D4 · PubChem CID 7628
4Empirical formula and molecular weight
H3BO3 · 61.83
5Functional category
Antimicrobial preservative, pH adjuster, buffering agent
Typical concentrations: — · Dosage forms: Sterile (parenteral/ophthalmic)
6Applications in pharmaceutical formulation
Used mainly as a buffering agent, with sodium borate, in ophthalmic preparations and contact-lens solutions, and to adjust tonicity; it has weak antimicrobial activity and may contribute to preservation. It is also used in some eye washes, otic and topical preparations. It should not be used in products for internal use, on broken skin or in infants.
7Description
Colourless, odourless, lustrous crystals or a white crystalline powder or granules that feel slightly unctuous.
8Typical properties
- pKa
- ≈ 9.2 (a weak Lewis acid; acidity is increased by polyols such as glycerol and mannitol)
- Behaviour on heating
- loses water above about 100 °C, forming metaboric acid and eventually boron trioxide
- Solubility
- soluble in water (about 1 in 20 at room temperature) and freely soluble in boiling water and in glycerol; soluble in ethanol
- pH
- weakly acidic in aqueous solution (about pH 3.8–4.8 for a 3.3% solution)
9Stability and storage conditions
Stable and slightly hygroscopic. Store in an airtight container.
10Incompatibilities
Incompatible with alkali carbonates and hydroxides, and forms complexes with polyhydric alcohols (glycerol, mannitol, sorbitol), which increases its acidity. It can form complexes with polyvinyl alcohol and some other polyols, causing gelation, and it is incompatible with tannins.
11Method of manufacture
Prepared by treating borax (sodium tetraborate) or other borate minerals with sulfuric or hydrochloric acid, followed by crystallisation.
12Safety
Boric acid is toxic if swallowed or absorbed in quantity, for example from large areas of damaged skin or in infants, causing gastrointestinal, skin, CNS and renal effects. It is classified in the EU as a reproductive toxicant (Category 1B), and EU product information requires warnings and limits for medicines containing boron compounds, particularly for children under 2 years. At the concentrations used in eye drops it is generally well tolerated.
13Handling precautions
Avoid ingestion and inhalation of the dust; use gloves, eye protection and a dust mask. Because of its reproductive-toxicity classification, exposure of workers should be minimised.
14Regulatory status
Included in the FDA Inactive Ingredient Database (ophthalmic, otic and topical preparations) and in non-parenteral medicines licensed in Europe. In the EU it is permitted as a food additive (E284) only for sturgeon roe (caviar).
15Related substances
Sodium borate (borax); sodium perborate.
16Comments
Borate buffers are useful in the pH range of about 7–9 and are well suited to ophthalmic products, but they should not be combined with polyvinyl alcohol or with high levels of polyols without checking for complexation or gelation.