Benzalkonium Chloride

Benzalkonium Chloride (BKC) is a powerful antiseptic and a cationic surfactant.

What is Benzalkonium Chloride (BKC)?

Benzalkonium Chloride is a powerful antiseptic and a cationic surfactant. Benzalkonium Chloride is also known as BAC, BZK, BKC, BAK, alkyl dimethyl benzyl ammonium chloride and ADBAC.

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Novo Nordisk Pharmatech’s FeF Benzalkonium Chloride (BAK / BAC / BKC) group of products have proven efficacy against a broad spectrum of microorganisms (gram + and – & acid fast bacteria, yeasts, moulds and enveloped vira such as HIV, herpes and corona). They are effective through a wide pH range, are surface active/adhesive cationic agents and do not add unpleasant odour/colour to finished formulations.

cGMP-manufactured Benzalkonium Chloride

If uniform high quality is the key to your products, you should begin with ours. As the world’s leading supplier of quaternary ammonium compounds (Quats), we provide only the best and safest ingredients for the pharmaceutical and personal and health care industries. Our group ingredients are produced according to the highest cGMP standards and backed by complete regulatory documentation. This combination of high-purity products and regulatory services has made us an approved supplier to many of the world’s leading pharmaceutical companies.

We control and observe all aspects of our manufacturing process. When we are manufacturing, we monitor the critical parameters for each significant process. This monitoring includes for example temperature and PH level. Each finalized batch is analysed to pharmacopoeia requirements, to deliver a Certificate of Analysis at batch release by our QA. We strive for complete uniformity in our operations and everything we do is embraced by good manufacturing practices.

We are highly specialised in pharmaceutical grade Quats. The uniform quality of our finished products – and of yours – is ensured by our efficient quality control systems, computerised materials planning and rigorous laboratory quality control. In-process samples, as well as finished products, are carefully analysed in our modern, well-equipped laboratory.

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BKC Ph.Eur., USP/NF

Contains approx. 95% active ingredients and consists of

  • Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%)
  • Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%)

BKC Ph.Eur., USP/NF, JP

Contains approx. 95% active ingredients and consists of

  • Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%)
  • Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%)

BKC Solution 50% Ph.Eur., USP/NF

Contains approx. 50% active ingredients and consists of

  • Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%)
  • Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%)

BKC Solution 50% Ph.Eur., USP/NF, JP

Contains approx. 50% active ingredients and consists of

  • Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%)
  • Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%)

BKC Solution 50% (45/55) Ph.Eur., USP/NF

Custom-designed product that contains approx. 50% active ingredients and consists of

  • Benzyl (dodecyl) dimethyl ammonium chloride (approx. 45%)
  • Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 55%)

BKC Solution 50% (53/30/15/2) Ph.Eur., USP/NF

Custom-designed product that contains approx. 50% active ingredients and consists of

  • Benzyl (dodecyl) dimethyl ammonium chloride (approx. 53%)
  • Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 30%)
  • Benzyl (hexadecyl) dimethyl ammonium chloride (approx. 15%)
  • Benzyl (octadecyl) dimethyl ammonium chloride (approx. 2%)

BKC Solution 17% USP/NF

Custom-designed solution that contains approx. 17% active ingredients and consists of

  • Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%)
  • Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%)

Product attributes

  • Proven record of efficacy against a broad spectrum of microorganisms
  • Effective through a wide pH range
  • Odourless and colourless in your formulation
  • Surface active / adhesive cationic agent
  • Very stable, proven under ICH Q1 conditions
  • Five-year shelf life

Benzalkonium Chloride (BKC) applications

Our innovative synthesis process makes Novo Nordisk Pharmatech a leading supplier of quaternary ammonium compounds (Quats) for a wide range of applications. Benzalkonium Chloride (BAC / BAK / BKC) acts either as a preservative or active ingredient in many ophthalmic, nasal, oral and topical drugs and in a variety of solutions, ointments and creams.

For more information see the different areas of Benzalkonium Chloride applications below.

Ophthalmics

The safety, the purity or the efficacy of ophthalmic products are under constant threat of microbial contamination. Therefore, it is crucial to utilize an effective preservative of the purest and safest ingredients. Benzalkonium Chloride is used as a preservative in both human and veterinary ophthalmics and is the most common and effective preservative.

Our Benzalkonium Chloride (BAC / BAK / BKC) is broadly used as excipient in ophthalmic gels, ointments and solutions. The concentration generally varies from 0.001% up to 0.2%.

Read more about our Quats applications for ophthalmics here.

Nasal formulations

It is essential to preserve against contamination by employing only the purest and safest ingredients when formulations are in contact with mucosal tissue. One of the most commonly used and effective preservatives is Benzalkonium Chloride and our Benzalkonium Chloride (BAC / BAK / BKC) is extensively used as an excipient in drops, nasal sprays and ointments. Here the concentration generally varies from 0.005% up to 0.2%.

Read more about our Quats applications in nasal formulations here.

Topical formulations

Quats act on a wide range of microorganisms and are popular antiseptics with a broad history of use in topical products such as antiseptic liquids, hand sanitizers, gels and creams.

Our Benzalkonium Chloride (BAC / BAK / BKC) is used in both human and veterinary topicals such as hand sanitizers, skin cleansing solutions, surgical wash, antiseptic creams and in spermicides foams, creams and ampoules.

Read more about our Quats applications in topical formulations here.

Oral or dental formulations

It is necessary to employ only the purest and safest ingredients when formulations are in contact with buccal tissue. Benzalkonium Chloride can be used as excipient or as active pharmaceutical ingredient (API) for oral and dental formulations.

Novo Nordisk Pharmatech’s Benzalkonium Chloride (BAC / BAK / BKC) can be used as an API in lozenges to treat superficial infections in the mouth and throat. BKC can for example be found in gels and creams for herpes treatment and cold sores infections. BKC are also quite commonly used in antiseptic mouth sprays.

Read more about our Quats applications in oral and dental formulations here.

Wound care and medical devices

Pure and safe ingredients are vital when medical devices are in contact with either healthy or damaged organic tissue.

Our Benzalkonium Chloride (BAC / BAK / BKC) is used for a wide variety of applications such as:

  • Gauzes, wipes, plasters and patches with typical concentrations of 0.01 to 1%
  • Skin and wound cleansing with solutions of 0.01 to 1%
  • Catheters
  • Irrigation solutions with aqueous solutions of 0.005 to 0.02% and 0.0025 to 0.005% solutions for retention lavage of the bladder.
  • Surgical glues

Read more about our Quats applications in wound care and medical devices here.

Personal care

Our Quats are odourless and colourless, and with their efficacy in all pH ranges they are famed antiseptics with a lasting history of use in topical personal care products such as facial scrubs, creams and cleansing gels.

Our Benzalkonium Chloride (BAC / BAK / BKC) is used for skin cleansing solutions, wounds, mucous membranes with a concentration of 0.01 to 0.1%.

Read more about our Quats applications in personal care here.

Contraception formulations

Benzalkonium Chloride is scientifically proven to be a successful spermicide. Our Benzalkonium Chloride (BAC / BAK / BKC) is used in various spermicidal products with a concentration of active Quat that generally varies from 0.1 to 1.5%.

These products include spermicidal gels, creams, soft capsule, foams, sponges, solutions and vaginal tables and suppositories

Read more about our Quats applications in Contraception formulations here.

Antiseptic agents

Benzalkonium Chloride is greatly used in formulations for direct topical application that normally contain between 0.1 and 0.5% active Quat. This concentration contributes both with a preservative effect for the solution and an antiseptic effect on the skin.

Read more about our Quats applications in antiseptic agents here.

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Antimicrobial effect

Novo Nordisk Pharmatech’s Quats are effective at all pH levels. Our Quats effectiveness increases when the pH increases which means that the higher the pH levels, the lower the concentration needed to secure an antimicrobial effect. Quats are bactericidal & fungicidal and are therefore able to eliminate micro-organisms whether in a growth phase or not.

Through tests against a number of chosen strains, our Benzalkonium Chloride (BAC / BAK / BKC) has revealed to be successful against a broad range of harmful bacteria and yeast.

Benzalkonium Chloride is likewise effective in deactivating enveloped viruses such as corona, influenza, herpes and hepatitis, at low concentrations. Various publications back the usage of Benzalkonium Chloride as an effective anti-viral, for example against type A influenza, SARS-CoV, M31yxo- and related viruses, measles, herpes simplex, adenovirus type 5, canine distemper, feline pneumonitis, meningopneumonitis agents, HIV-1 and more.

Extensive documentation

We offer an extensive range of documentation to help you meet registration and regulatory requirements for your products or group of products including multicompendial analysis and access to regulatory documentation. We ensure the best possible service and fast preparation of documentation, such as Drug Master Files. To further facilitate your drug registration requirements, we offer access to our Certificates of Suitability according to the Monographs of the European Pharmacopoeia for Benzalkonium chloride solution 50% and Benzalkonium chloride.

We also make sure to network with European companies and organisations like ourselves and frequently participate in conferences to stay updated. We have access to information databases and libraries, and specialists are available to help us adapt to new regulations and trends in the market.

Our quality system meets DS/EN ISO 9001 and the ICH Guide Q7 for Active Pharmaceutical Ingredients (ICH Q7). We offer complete QA/QC documentation for our cGMP manufactured Quats.

Mette Borgaard
Customer Support Assistant

Phone: +45 2429 4134
Email: [email protected]