The value of antiseptics in modern healthcare
Antiseptics are a cornerstone of infection control. Unlike disinfectants, which are intended for use on non-living surfaces, antiseptics are formulated for direct application to living tissue—most often skin. In this way, they play a vital role in both everyday hygiene and high-stakes clinical settings, helping to reduce the microbial load on the skin and prevent infection before it takes hold.
Benzalkonium Chloride (BKC), a well-established quaternary ammonium compound (Quat), is widely recognised for its broad-spectrum antimicrobial activity and biocompatibility. Thanks to its unique ability to target the lipid membranes of bacteria, fungi, and enveloped viruses, BKC is used extensively as an active pharmaceutical ingredient (API) and excipient in a range of antiseptic products—from antibacterial gels and creams to wound care formulations.
As infection prevention becomes an even greater focus within healthcare systems and among consumers, the demand for safe, effective, and skin-friendly antiseptics continues to grow. BKC meets this need with a proven track record spanning decades, supported by robust pharmacopoeial recognition and extensive regulatory acceptance worldwide.
At Novo Nordisk Pharmatech, we produce pharmaceutical-grade BKC under cGMP conditions with a singular focus on quality, consistency, and compliance. In this article, we explore the role of Benzalkonium Chloride as an antiseptic—examining its scientific mechanism, clinical applications, and the value it offers as a key ingredient in modern antimicrobial formulations.
The science behind BKC as an antiseptic
BKC is a cationic surfactant belonging to the quaternary ammonium compounds—a class of molecules known for their high affinity to microbial cell membranes. What sets BKC apart as an antiseptic is not just its broad-spectrum antimicrobial activity, but its unique chemical properties.
- Stability: BKC has a positively charged nitrogen atom bonded to four organic groups. This structure contributes to its stability as the positive charge on the nitrogen is delocalized, reducing the likelihood of chemical reactivity.
- Hydrophobic and hydrophilic balance: BKC is amphiphilic, allowing for effective interactions with both polar and non-polar environments. This unique balance contributes to its stability in various formulations, preventing phase separation and degradation.
- Resistance to hydrolysis: BKC is generally resistant to hydrolysis, making it stable in aqueous solutions and preventing breakdown into potentially less effective compounds. This resistance is crucial for maintaining antimicrobial efficacy over time.
- Thermal stability: BKC exhibits thermal stability, allowing it to withstand a range of temperatures without decomposing. This is advantageous in formulations subjected to varying storage and processing conditions.
- Low pH sensitivity: BKC remains stable across a range of pH values compared to other compounds that may degrade or lose efficacy under acidic or basic conditions.
- Non-volatile: This helps maintaining its concentration in formulations without concerns related to evaporation. This characteristic preserves the effective dosage of BKC over the shelf life of the product.
These properties enable BKC’s efficacy and stability at very low concentrations, ensuring its biocompatibility and suitability for application directly onto human skin and mucosa. Leveraging these unique properties, BKC can be employed effectively in pharmaceutical applications, enhancing product performance while maintaining low toxicity and high safety profiles.
Mechanism of Benzalkonium Chloride
At the molecular level, BKC exerts its antimicrobial effect by integrating into the lipid bilayers of microbial membranes. Its positively charged ammonium group binds to negatively charged phospholipids, while the hydrophobic alkyl chain embeds within the membrane.
This dual interaction disrupts the structural integrity of the membrane, increasing its permeability and ultimately leading to leakage of cytoplasmic contents, metabolic disruption, and cell death—a process known as cytolysis.
This mechanism is effective against a wide range of pathogens, including antibiotic-resistant strains:
- Gram-positive and gram-negative bacteria (e.g., Staphylococcus aureus, Pseudomonas aeruginosa),
- Fungi and yeasts (e.g., Candida albicans),
- Enveloped viruses (e.g., herpes simplex, influenza, SARS-CoV-2).
This broad and reliable antimicrobial action makes BKC an essential ingredient across numerous medical and personal care products—from wound cleansers and surgical prep solutions to hand sanitizers and surface disinfectants.
Antiseptic gels
The widespread demand for antiseptic gels—both in clinical and consumer healthcare—has highlighted the need for active ingredients that are effective, non-irritating, and adaptable to frequent use. Benzalkonium Chloride (BKC) meets all these criteria, making it one of the most trusted actives in the formulation of skin-safe antiseptic gels.
Unlike alcohol-based products, which can dry out or irritate the skin, BKC provides a gentler, non-volatile alternative with proven antimicrobial efficacy. It is particularly valuable in healthcare settings, where personnel are required to perform frequent hand antisepsis and need a product that balances performance with tolerability.
In antiseptic gels, BKC is typically used at a 0.1-0.13% concentration—a level that is both clinically effective and dermally safe. At this concentration, BKC delivers rapid action against a broad range of pathogens including Staphylococcus, E. coli, Pseudomonas, Candida, and enveloped viruses such as coronavirus and influenza. Its mode of action—targeting and disrupting the microbial cell membrane—ensures a fast onset of antimicrobial activity while also providing residual protection on the skin’s surface.
This residual effect is one of the key differentiators of BKC-based gels. Once applied, BKC forms a persistent antimicrobial barrier that remains active long after the product has dried, reducing the need for constant reapplication and lowering the risk of cross-contamination between uses. This is especially relevant in clinical workflows, where recontamination risk between patient interactions must be minimised.
BKC’s surfactant characteristics facilitate the solubilization of active ingredients, enhancing their bioavailability and stability. Its formulation stability is another advantage in gel products. Its compatibility with common gelling agents, humectants, and emollients allows formulators to develop products that not only meet regulatory efficacy requirements but also address user comfort—offering skin-friendly, non-sticky textures with a clean finish. Furthermore, the molecule’s non-flammable, odourless, and colourless properties contribute to greater safety in handling and ease of patient acceptance.
In both hospital and outpatient environments, BKC gels are used in hand hygiene stations, surgical prep routines, and patient room sanitation protocols. Outside of clinical practice, these gels are increasingly used by the general public in portable formats—providing convenient antimicrobial protection in schools, offices, travel kits, and homes.
From its high safety margin to its regulatory standing, BKC continues to be the active of choice for developers seeking a reliable, alcohol-free gel antiseptic. Backed by Novo Nordisk Pharmatech’s pharmaceutical-grade quality, BKC ensures the consistency and purity needed to develop effective and compliant gel-based antiseptic products.
Antiseptic creams
Semi-solid formulations—such as creams and ointments—represent one of the most established and trusted formats for delivering antiseptic care directly to compromised or sensitive skin. Benzalkonium Chloride (BKC), with its dual role as both an active pharmaceutical ingredient and a functional excipient, plays a central role in enhancing the safety and efficacy of these topical products.
Antiseptic creams and ointments containing BKC are widely used for treating and preventing infection in minor wounds, cuts, abrasions, burns, and for managing dermatological conditions such as acne, eczema, psoriasis, and nappy rash. In these applications, BKC is typically formulated at concentrations ranging from 0.01% to 1%, depending on the severity of microbial threat, the condition being treated, and regulatory guidelines.
In cream-based formulations, BKC is often used in oil-in-water emulsions, where it provides broad-spectrum antimicrobial activity while maintaining skin hydration and barrier function. Its compatibility with common emollients, humectants, and stabilisers ensures that the formulation remains both effective, safe and cosmetically acceptable. In ointments—typically more occlusive and oil-rich—BKC helps preserve sterility and prevent microbial growth in long-contact applications, such as overnight treatments or dressings.
One of the defining advantages of BKC in these formats is its low irritancy profile. Unlike certain alcohols or peroxide-based agents, BKC at medically approved concentrations is non-stinging, making it ideal for use on sensitive or broken skin and in paediatric and geriatric care. Moreover, its residual activity continues to inhibit microbial colonisation even after application, reducing the need for frequent reapplication and contributing to patient compliance.
The molecule’s high stability across pH and temperature variations also enables formulators to develop multi-functional products, that not only treat infection but also support healing, reduce inflammation, and restore the skin’s microbiological balance.
For over-the-counter (OTC) antiseptic creams, BKC offers formulators a pharmacopoeia-recognised, globally compliant antimicrobial active that can be confidently marketed in both regulated and emerging markets. For prescription-strength products, its documented efficacy and safety make it an ideal candidate for inclusion in first-line topical treatments used in clinical dermatology and hospital wound care.
Antiseptic sprays and foams
Sprays and foams are increasingly favoured in antiseptic applications for their ability to deliver broad, even, and touch-free coverage—a critical advantage in both clinical and emergency care settings. Benzalkonium Chloride (BKC), with its proven efficacy, formulation flexibility, and excellent skin tolerability, is an ideal antimicrobial agent for these delivery systems.
BKC-based sprays and foams are commonly used in first-aid treatments, pre-procedural skin preparation, and post-operative care—particularly when rapid application, minimal contact, and coverage over larger surface areas are required. Their use ranges from household medicine cabinets to ambulatory care units, where hygiene and speed are equally important.
These formats typically feature BKC concentrations from 0.1% to 0.2%, offering fast-acting, broad-spectrum protection against bacteria, fungi, and enveloped viruses. The antimicrobial action is immediate upon contact and continues to provide residual protection, helping to reduce the risk of secondary infection after minor injuries or procedures.
BKC’s water solubility and stability make it exceptionally well-suited for use in sprayable solutions and aqueous foams. It remains effective in high-humidityenvironments, allowing sprays and foams to maintain performance even under challenging conditions. Additionally, BKC’s compatibility with non-alcoholic systems enables the creation of non-flammable, low-odour products suitable for use in oxygen-rich or paediatric settings—where alcohol-based antiseptics may pose risks.
Foams, in particular, offer added user control and reduced runoff, making them ideal for application to curved, irregular, or vertical skin surfaces. Combined with emollients or moisturising excipients, BKC foams can deliver antimicrobial efficacy while maintaining skin integrity, even with repeated use.
Because BKC does not evaporate like alcohol, these products provide a longer-lasting barrier to microbial invasion—without the need for frequent reapplication. This makes BKC-based sprays and foams especially valuable in high-traffic clinical environments, emergency response kits, and field medicine, where sterility and convenience must go hand in hand.
Antiseptic wipes and towelettes
Impregnated wipes and towelettes offer a practical, portable, and highly effective method for delivering antiseptic treatment—particularly in environments where convenience, sterility, and single-use hygiene are paramount. Benzalkonium Chloride (BKC), with its fast-acting antimicrobial properties, formulation stability, and skin compatibility, is an ideal active for these pre-saturated delivery systems.
BKC-based antiseptic wipes are used extensively in clinical, surgical, and consumer healthcare settings for skin cleansing prior to injections, wound care, and general hygiene maintenance. They are also widely adopted in field medicine, first aid kits, and emergency response applications, where reliable disinfection must be delivered without access to running water or conventional topical products.
The typical BKC concentration in impregnated wipe solutions ranges from 0.1% to 0.2%, depending on the intended use and required contact time. These concentrations are sufficient to inactivate a broad spectrum of pathogens—including Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, and enveloped viruses such as coronavirus and herpes simplex—within seconds of application.
BKC’s non-volatile nature ensures that the impregnated liquid remains within the fabric matrix of the wipe, rather than evaporating prematurely, as seen with alcohol-based solutions. This not only improves product shelf life and handling safety but also contributes to sustained antimicrobial activity on the skin—an important feature in reducing recontamination risk.
The molecule’s stability across a broad pH range and its compatibility with both hydrophilic and lipophilic ingredients allow manufacturers to tailor wipe formulations for specific needs: from gentle cleansing in paediatric and elderly care, to more concentrated clinical-grade applications for pre-surgical or catheter-related skin prep.
Furthermore, BKC’s low irritation profile makes it particularly well-suited for repeated or frequent use, reducing the likelihood of dermatitis or barrier disruption—a concern in healthcare professionals who rely on such products throughout their daily routines.
Explore BKC’s Role in topical formulations
Want a deeper dive into how BKC delivers safe, effective, and persistent antimicrobial protection in topical products? Our white paper covers formulation strategies, regulatory insights, and performance data for BKC in topicals.
Pharmaceutical-grade BKC you can trust
At Novo Nordisk Pharmatech, we have dedicated more than 75 years to the development and production of high-purity Benzalkonium Chloride—supporting the world’s leading healthcare and pharmaceutical companies with an ingredient they can rely on.
Our Benzalkonium Chloride is manufactured under strict cGMP conditions to ensure the quality, consistency, and regulatory compliance required for antiseptic formulations. Whether used in gels, creams, foams, wipes, or sprays, our BKC delivers proven antimicrobial efficacy and excellent formulation safety and stability.
Odourless, colourless, and effective across a broad pH range, our BKC is designed to integrate seamlessly into both over-the-counter and prescription antiseptic products. It is available in multiple concentrations and packaging formats to support formulation flexibility and production scalability. With a five-year shelf life and a strong global supply chain, our BKC is a solid asset for critical healthcare applications.
In addition, we offer a comprehensive regulatory documentation package—including full pharmacopoeial compliance (Ph. Eur., USP/NF, JP), stability data, and impuritystatements—to simplify your product registration process and accelerate your time to market.
When safety, efficacy, and compliance matter most, Benzalkonium Chloride from Novo Nordisk Pharmatech delivers the confidence you need to bring world-class antiseptic solutions to life.
