Cetyl Trimethyl Ammonium Bromide (CTAB), USP/NF

Use of CTAB

As a quaternary ammonium compound, FeF CTAB USP/NF is a very efficient germicide which is active against most common micro-organisms, such as bacteria, fungi and enveloped viruses. FeF CTAB USP/NF is widely used in the pharmaceutical industry as an active ingredient (API) and is an antiseptic agent with strong antibacterial, antifungal and antiviral properties. CTAB is used in antiseptic creams and ointments, and in the cosmetic industry as a conditioner and/or preservative.

CTAB is used in various products such as throat lozenges and antiseptic topical gels and creams. As a processing aid or auxiliary/ancillary, it can be used as a surfactant in the downstream vaccine manufacturing process, for both bacterial polysaccharide vaccines and viral vaccines (e.g. influenza).

In bioprocesses, CTAB is a cationic surfactant and is crucial in breaking up cell membrane, initiating cell lysis to isolate antigenic material. It protects from co-precipitated membrane lipids, allowing for efficient antigen isolation with high yields.

CTAB is also well established as a surfactant for use in purification steps in vaccine downstream processing. Read more about CTAB in vaccines here.

CTAB is employed in DNA extraction / isolation and in manufacturing of novel Gene Therapies, e.g. as a non-viral vector. As a processing aid or auxiliary/ancillary, it is used as a surfactant in the downstream vaccine manufacturing process, for both bacterial polysaccharide vaccines and viral vaccines (e.g. influenza).

CTAB in polysaccharide (bacterial) vaccines

Cetrimonium bromide / Cetyltrimethylammonium bromide / hexadecyltrimethylammonium bromide is recommended by the World Health Organisation (WHO) as a purification agent in the downstream vaccine processing of polysaccharide vaccines. These vaccines are used to prevent for example pneumococcal disease, meningococcal disease, and Salmonella Typhi. Polysaccharide vaccines are a type of inactivated subunit vaccine that are included in many child vaccination programmes.

During the purification process, Cetrimonium bromide / CTAB can be used within the buffer system of polysaccharide vaccines. The cationic surfactant removes membrane lipids and promotes cell lysis, thus ‘freeing-up’ the polysaccharides. This is referred to as precipitation and enables the manufacturer to obtain higher yields of polysaccharides.

CTAB in viral vaccines

Our CTAB can also be used in the downstream processing of viral vaccines. After the inactivation of the live virus, manufacturers of viral vaccines must isolate the virus antigens from the culture media, and remove any contaminants and undesired proteins, thereby increasing immunogenicity.

During centrifugation, CTAB can be applied to separate the virus from the remaining components. In the manufacturing of influenza vaccines, CTAB will solubilise the viral antigens such as influenza hemagglutinin (HA) surface proteins. This can also be carried out using a mixture of CTAB with Polysorbate / Tween 80.

Influenza vaccines are typically egg-based but further production methods include cell-based and recombinant (DNA). CTAB can be used across all three of these and is also utilised in the genomic DNA extraction and in the manufacturing of novel gene therapies.

Pharmaceutical grade CTAB

In vaccine manufacturing, every potential risk must be eliminated or minimised, and one way manufacturers can achieve this is through the use of the safest and most pure materials. Whenever possible, manufacturers should aim to source processing aids of pharmaceutical-grade, that have been manufactured to cGMP standards.

Novo Nordisk Pharmatech is the only manufacturer offering CTAB in cGMP pharmaceutical grade for APIs. Our FeF CTAB USP/NF product is produced in full compliance with ICH Q7, meaning:

• Full traceability
• Full USP/NF compliance
• High product purity
• Complete regulatory documentation package
• Complete audit access

FeF CTAB USP/NF is manufactured to a consistent high quality as a result of our well-established processes and thorough quality control, with inspection from the Danish Medicine Agency (DMA).

Customers using this pharma-grade CTAB are assured that it is has been manufactured to the highest quality standards and methods, using the best raw ingredients under a fully validated process where critical parameters are constantly monitored.

Uniform quality

Our FeF CTAB USP/NF product has proven efficacy against a broad spectrum of microorganisms (gram + and – & acid fast bacteria, yeast, moulds). It is effective through a wide pH range, is surface active/adhesive cationic and does not add unpleasant odour/colour to finished formulations.

The uniform quality and purity of our products – and of our customers’ products – is ensured by our efficient quality management systems and protocols, dedicated equipment, well established processes and rigorous laboratory quality control.

Packing information and distribution

CAS No. 57-09-0.

We keep stock of our pharmaceutical products and our entire product range is offered in a variety of packing solutions, meeting demands for small- and large-size packaging. Our Quats products, CTAB included, are also distributed in line with GDP and Known Consignor.

All of our Quats products are sold globally. We sell Quats in more than 70 countries across Europe, the Middle East, Asia, North America, South America and Africa. We are supported by a global network of distributors ranging across India, Europe, Asia, Australasia and North America. Our global distributor network provides our customers access to a local supplier and point of contact for their products.

Please note that product Item no. 7800023 is only manufactured to order.

All deliveries of Cetyl Trimethyl Ammonium Bromide (CTAB) includes the following documentation and services

• European Drug Master File (ASMF)
• GMP Certificate (enter Certificate number DK API-H 00073316 and choose Denmark in the country field list)
• Certificate of Analysis (current version of pharmacopoeia)
• Datasheet
• Customer audits
• Stability results
• Declarations, statements (TSE/BSE, residual solvents, GMO, allergens, animal testing, etc.)
• Reach compliance
• Change Notification Statement
• Pre-filled Supplier Questionnaire
• Impurity profile
• Description of the manufacturing process
• Process flowchart
• Packaging details
• Quality Agreements

Specifications

Identification: Complies USP/NF

Appearance of solution: Clear and colorless

Total Aerobic Microbial Count: Max. 1000 CFU/g

Total comb. Yeast/Mould Count: Max. 10 CFU/g

Acidity or alkalinity: Max. 0.1 ml 0.1M HCl or NaOH

Loss on drying: Max. 0.5% w/w

Residue on ignition: Max. 0.5% w/w

Amines and amine salts: Max. 0.4 ml/g

Assay: 96.0 – 101.0%

Technical information

Standards: The quality system meets DS/EN ISO 9001. The environmental system meets DS/EN ISO 14001 and 45001.

Grade: Pharmaceutical grade.

Quality: The product is manufactured in accordance with the cGMP Guide for Active Pharmaceutical Ingredients (API) ICH Q7.

Documentation: Drug Master File (EDMF/ASMF)

TSE: Does not contain materials of animal origin.

Solubility: Soluble in water and lower alcohols, such as methanol, ethanol and propanol in all ratios. Also insoluble in benzene and ether.

Compatibility: Mixing with ordinary soaps and/or with anionic detergents may decrease the activity.

Density: Approx. 0.5 g/ml.

Melting point: Approx. 230 °C

Packaging: Consist of double plastic bags made of transparent blue LDPE in either a cardboard box or a plastic drum.

Shelf life: 5 years.

Storage: Avoid conditions causing condensation. Store protected from excessive heat. The product may compact during storage.

With more than 70 years of Danish based experience, Novo Nordisk Pharmatech is the leading supplier of pharma grade Quats. You can find more information about our Quaternary ammonium compounds products here. Please contact us for information about price and delivery.

Buy CTAB (Cetrimonium Bromide)

If you want to buy Cetrimonium Bromide (CTAB), please contact us for information about price and delivery. We sell Cetrimonium Bromide to customers worldwide.