Novo Nordisk Pharmatech quaternary ammonium compounds (Quats)

Innovative Danish Novo Nordisk Pharmatech is a renowned supplier of very high quality quaternary ammonium salts (Quats), Benzalkonium Chloride, Cetrimide, and Cetrimonium Bromide (CTAB), which have powerful antimicrobial properties as active ingredients or preservatives in pharmaceutical and biopharma applications, and are used as surfactants in downstream processing (DSP) biotech production.

Quaternary ammonium disinfectants have many roles across healthcare and are also valuable APIs in combating infections.

Quat applications

Quaternary ammonium compounds have a wide variety of applications across the life sciences, both as direct therapies and for research and manufacturing uses.

These applications include:

• Ophthalmics: Benzalkonium Chloride (BKC) is widely used as an excipient in ophthalmic solutions, in concentrations typically varying from 0.001% up to 0.2%. It protects multidose sterile pharmaceutical products from contamination, both from environmental and corporeal flora.
• Nasal formulations: BKC is one of the most effective preservatives in nasal formulations , helping to preserve against contamination by utilizing only the purest and safest ingredients.
• Topical formulations: Novo Nordisk Pharmatech Quats products are widely used in both human and veterinary topical formulations, such as hand sanitizers, antiseptic liquids, creams and gels. They act on a wide range of microorganisms, including enveloped viruses, gram+ and gram- bacteria, molds and yeasts. Novo Nordisk Pharmatech’s BKC, Cetrimide and CTAB Quats are odorless and colorless, and effective in all relevant pH ranges. Their ability to mix well in both aqueous and oily phases make them ideal antimicrobial ingredients in topical creams.
• Oral or dental formulations: Quats can be used either as excipients or active pharmaceutical ingredients (APIs) for oral and dental formulations. In particular, Benzalkonium Chloride (BKC) can be used as an API in lozenges to treat superficial mouth and throat infections, in gels and creams to treat herpes and cold sores infections, and in antiseptic mouth sprays. In dentistry, Quats are also used either as active antiseptics or preservatives, in rinsing fluids and antiseptic fills.
• Wound care & medical devices: The purity of Novo Nordisk Pharmatech’s pharmaceutical grade BKC makes it highly useful in dressings and medical devices that come into contact with organic tissue. Applications include gauzes/wipes/plasters/patches, skin and wound cleansing fluids, catheter disinfection, irrigation solutions, and surgical glues.
• Vaccine production: Novo Nordisk Pharmatech’s cGMP manufactured pharmaceutical grade CTAB has multiple roles in vaccine production. It can be used in downstream processing of viral vaccines, such as influenza vaccines, . As a powerful cationic surfactant, use of CTAB is WHO-recommended as a purification agent, serving as a surfactant in a buffer system, to remove membrane lipids and promote cell lysis, to “free-up” the polysaccharides. Further downstream, CTAB is used as a cationic detergent to isolate antigenic agents, such as influenza HA proteins and for purification of egg-based, cell-based and recombinant (DNA) vaccines. Sub unit isolation can be done using a mixture of Tween 80 with CTAB, to separate RNP (Ribonucleoprotein) particles from the surface antigen proteins by centrifugation.
• Personal care: Quats are well-known antiseptics and have a long history of use in topical products for personal care. They act on a wide range of microorganisms, from enveloped viruses to gram+ and gram- bacteria, moulds and yeasts.
• Contraceptive formulations: BKC is scientifically proven to be an effective spermicide and is used in various spermicidal products, such as spermicidal gels, creams, foams and solutions.
• Veterinary products: Quats are widely recognized as efficient antimicrobial actives or excipient and are used in numerous formulations for ophthalmic and topical use in animals.
• Antiseptic agents: Solutions for direct topical application will normally contain between 0.1 and 0.5% active Quat. In these concentrations, they provide both a preservative effect for the solution and also an antiseptic effect on the skin.
• Diagnostic testing: Novo Nordisk Pharmatech’s Quats have proven to be significantly superior in diagnostic reagents compared to other less pure compounds, due to their high purity and the high consistency between batches.

Novo Nordisk Pharmatech Quats benefits

Novo Nordisk Pharmatech has more than 30 years’ experience in GMP manufacturing, and is the only quaternary ammonium compound (Quat) manufacturer offering products in cGMP manufactured pharmaceutical grade, in full compliance with ICH Q7.

The company’s efficient quality management systems, dedicated equipment, well-established and fully validated processes, and rigorous laboratory quality control ensure the uniform quality of its products, including Quats. It manufactures pharmaceutical grade Quats in accordance with the cGMP Guide ICH Q7 for Active Pharmaceutical Ingredients (APIs), the highest available quality standard in the industry. It is inspected by the FDA and the Danish Medicine Agency (DMA). Other specific user benefits include:

• Full traceability
• High product purity
• Full pharmacopeial compliance to Ph. Eur, USP/NF, JP, BP, CHP
• Audit access
• Full regulatory documentation package
• Manufactured under fully validated processes

Resources

Click on Quats applications to learn more.
Click on Benzalkonium chloride as antiseptic and cationic surfactant to learn more.
Click on Cetrimide: proven effective against broad spectrum of microorganisms for further information.
Click on CTAB: surfactant and antiseptic agent with antibacterial, antifungal and antiviral properties for further information.
Click on Novo Nordisk Pharmatech pharmaceutical grade quaternary ammonium compounds to download product brochure.