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Perboric acid | CAS No: 14034-78-7 | GMP-certified suppliers
A medication that provides topical antiseptic and cleansing benefits for minor oral wounds, supports dry eye preservative formulations, and serves as a disinfectant in medical and personal care products.
Therapeutic categories
AcidsAlimentary Tract and MetabolismAnionsAntiinfectives and Antiseptics for Local Oral TreatmentBoric AcidsBoron Compounds
Generic name
Perboric acid
Molecule type
small molecule
CAS number
14034-78-7
DrugBank ID
DB13235
Approval status
Approved drug
ATC code
A01AB19
Primary indications
- In the industry, sodium perborate is used as a disinfectant
- It is also part of the ingredients for detergents, bleach powders, and personal care formulations
- In cosmetic products, perboric acid and mainly its salt are used as an oxidizing agent for dyeing or permanent waving
Product Snapshot
- Perboric acid is primarily available as a powder for solution, classified as an oral small molecule compound
- It is predominantly used as a disinfectant and oxidizing agent in detergents, cosmetics, dental care, and ophthalmic preservative formulations
- This compound is approved for use in the US market, including for ophthalmic preparations where it functions as a preservative
Clinical Overview
Perboric acid (CAS number 14034-78-7) is primarily encountered in its salt form as sodium perborate, which can exist as either a monohydrate or tetrahydrate. It belongs to the class of inorganic metalloid oxides, characterized by oxygen atoms bonded to metalloids with an oxidation state of -2.
Clinically and industrially, sodium perborate serves multiple functions. It is approved by Health Canada since 2004 as a disinfectant for medical instruments. The U.S. Food and Drug Administration (FDA) authorizes sodium perborate in topical ointments for the protection against poison ivy dermatitis. Additionally, it finds application in dentistry as a cleansing agent for minor oral wounds, canker sores, and in the removal of phlegm or secretions. In ophthalmic formulations, sodium perborate is utilized as a preservative in products intended for dry eye treatment, a use supported by its rapid degradation into non-toxic byproducts.
The pharmacological activity of perboric acid is based on its role as a source of active oxygen. Upon contact with water, perboric acid hydrolyzes to hydrogen peroxide and borate ions. The generation of hydrogen peroxide leads to oxidative damage of bacterial cellular components, thereby exerting antiseptic effects. Systemic absorption and effects are considered negligible due to the compound’s limited bioavailability.
From an ADME perspective, perboric acid is not anticipated to undergo systemic metabolism, and its safety profile largely derives from local, topical use and rapid degradation products. Safety concerns focus on local irritation potential rather than systemic toxicity.
In addition to medicinal uses, sodium perborate is incorporated in bleaching agents, detergents, and personal care products, where it functions as an oxidizing agent for hair dyeing and permanent waving. Its inclusion in such formulations underscores the need for stringent quality control to ensure consistent purity and concentration.
Procurement of perboric acid APIs must consider compliance with pharmacopeial standards and appropriate certification for intended uses, especially for pharmaceutical or ophthalmic applications. Batch-to-batch consistency, absence of heavy metal contaminants, and stabilizing excipients are essential quality parameters to ensure safety and performance in finished products.
Clinically and industrially, sodium perborate serves multiple functions. It is approved by Health Canada since 2004 as a disinfectant for medical instruments. The U.S. Food and Drug Administration (FDA) authorizes sodium perborate in topical ointments for the protection against poison ivy dermatitis. Additionally, it finds application in dentistry as a cleansing agent for minor oral wounds, canker sores, and in the removal of phlegm or secretions. In ophthalmic formulations, sodium perborate is utilized as a preservative in products intended for dry eye treatment, a use supported by its rapid degradation into non-toxic byproducts.
The pharmacological activity of perboric acid is based on its role as a source of active oxygen. Upon contact with water, perboric acid hydrolyzes to hydrogen peroxide and borate ions. The generation of hydrogen peroxide leads to oxidative damage of bacterial cellular components, thereby exerting antiseptic effects. Systemic absorption and effects are considered negligible due to the compound’s limited bioavailability.
From an ADME perspective, perboric acid is not anticipated to undergo systemic metabolism, and its safety profile largely derives from local, topical use and rapid degradation products. Safety concerns focus on local irritation potential rather than systemic toxicity.
In addition to medicinal uses, sodium perborate is incorporated in bleaching agents, detergents, and personal care products, where it functions as an oxidizing agent for hair dyeing and permanent waving. Its inclusion in such formulations underscores the need for stringent quality control to ensure consistent purity and concentration.
Procurement of perboric acid APIs must consider compliance with pharmacopeial standards and appropriate certification for intended uses, especially for pharmaceutical or ophthalmic applications. Batch-to-batch consistency, absence of heavy metal contaminants, and stabilizing excipients are essential quality parameters to ensure safety and performance in finished products.
Identification & chemistry
| Generic name | Perboric acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 14034-78-7 |
| UNII | HC4C3M1FO2 |
| DrugBank ID | DB13235 |
Pharmacology
| Summary | Perboric acid serves as a source of active oxygen, releasing hydrogen peroxide upon hydrolysis to exert oxidative antimicrobial effects. It primarily targets bacterial cellular components to achieve antiseptic activity without systemic absorption. Common applications include disinfectants, bleaching agents, and preservatives in personal care and ophthalmic products. |
|---|---|
| Mechanism of action | Perboric acid acts as a source of active oxygen. In contact with water, perboric acid hydrolyzes to hydrogen and borate. As an antiseptic, the formation of hydrogen peroxide oxidizes the cellular components of the surrounding bacteria and kills them. |
| Pharmacodynamics | No systemic effects are expected as it is highly unlikely that the substance will be systemically available. |
ADME / PK
| Absorption | Dermal absorption is assumed to be very low due to the high hydrophilicity of perboric acid and its ionic nature. |
|---|---|
| Half-life | As perboric acid and its sodium salt are rapidly degraded in the body, this pharmacokinetic property is studied in the terms of [DB09460] and [DB11091]. |
| Protein binding | As perboric acid and its sodium salt are rapidly degraded in the body, this pharmacokinetic property is studied in the terms of [DB09460] and [DB11091]. |
| Metabolism | If perboric acid or its sodium salt get in touch with body fluids, they will rapidly dissociate into hydrogen peroxide, carbonate and sodium ions which are naturally present in the body. The produced hydrogen peroxide is rapidly degraded in blood and tissues. As carbonate is part of the normal buffer system of the body it is unlikely to be absorbed in amounts that could disturb the normal balance of the body. The rest of the dissociation products are also not thought to produce any significant systemic modifications. |
| Route of elimination | As perboric acid and its sodium salt are rapidly degraded in the body, this pharmacokinetic property is studied in the terms of [DB09460] and [DB11091]. |
| Volume of distribution | As perboric acid and its sodium salt are rapidly degraded in the body, this pharmacokinetic property is studied in the terms of [DB09460] and [DB11091]. |
| Clearance | As perboric acid and its sodium salt are rapidly degraded in the body, this pharmacokinetic property is studied in the terms of [DB09460] and [DB11091].[ |
Formulation & handling
- Perboric acid is administered orally as a powder for solution, indicating formulation as an oral dosage form.
- As a small molecule inorganic compound, it does not exhibit peptide or biologic characteristics.
- Formulations should consider its solid state and moderate hydrophilicity (LogP 0.48) for dissolution and stability in solution.
Regulatory status
| Lifecycle | The API’s primary patent protection in the US expired recently, allowing for generic competition and increased market availability. The product is currently in a mature market stage with multiple approved generic formulations. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for perboric acid includes originator companies producing branded products primarily for the US market, exemplified by Amosan Oral Wound Cleanser and Amosan Wound Cleanser Cherry Flavour. These branded products demonstrate established presence in the US, with limited indication of significant activity in EU or other regions. Patent expiry status suggests potential or existing generic competition in the market. |
|---|
Safety
| Toxicity | Acute oral and dermal LD50 are 1500 mg/kg and >2000 mg/kg, respectively. The toxicity of perboric acid and its salt is thought to be local and reported to be slight irritation of the skin which can be explained by the release of hydrogen peroxide. Mutagenicity, fertility and carcinogenicity studies have not been performed but it is thought that the potential of perboric acid to produce mutagenic, fertility or carcinogenic effects is unlikely. |
|---|
High Level Warnings:
- 1
- Perboric acid and its salts may cause slight skin irritation due to hydrogen peroxide release
- Appropriate protective equipment is recommended during handling
Perboric acid is a type of Dental and Oral Agents
Dental and oral agents belong to the pharmaceutical API category, playing a crucial role in oral health care. These agents are specifically designed to address various dental and oral conditions, ranging from tooth decay and gum diseases to oral infections and inflammation.
One of the primary types of dental and oral agents is antimicrobial APIs. These active pharmaceutical ingredients are known for their ability to inhibit the growth of bacteria and fungi in the oral cavity, helping to prevent and treat infections. Common antimicrobial APIs used in dental and oral care include chlorhexidine, cetylpyridinium chloride, and triclosan.
Another important category is analgesic APIs, which provide pain relief in dental and oral procedures. These agents work by blocking pain signals and reducing inflammation. Popular analgesic APIs in dental care include lidocaine, benzocaine, and ibuprofen.
Fluoride APIs are widely used in dental products to strengthen tooth enamel and prevent tooth decay. These APIs aid in remineralization, making teeth more resistant to acid attacks from bacteria and sugary foods.
Furthermore, there are APIs specifically formulated for treating specific oral conditions such as dry mouth or halitosis. These agents help restore moisture in the mouth and neutralize odor-causing compounds.
Dental and oral agents are typically formulated into various dosage forms, including mouthwashes, toothpaste, gels, and oral sprays. These formulations ensure convenient and effective delivery of the APIs to the affected areas in the oral cavity.
In summary, dental and oral agents are a vital component of oral health care, offering antimicrobial, analgesic, remineralizing, and specific therapeutic benefits. Incorporating these pharmaceutical APIs into dental products helps individuals maintain optimal oral health and prevent dental problems.
