Cetrimide

FeF Cetrimide Ph.Eur.

CAS No. 1119-97-7.

Cetrimide consists of Trimethyl tetradecyl ammonium bromide and contains approx. 99% active ingredients.

FeF Cetrimide Ph.Eur. is manufactured in accordance with the cGMP Guideline ICH Q7 for Active Pharmaceutical Ingredients and analysed according to the current European Pharmacopoeia (Ph.Eur.).

The density of FeF Cetrimide Ph.Eur. is approx. 0.5 g/ml.

Chain length: Min. 95% w/w C14.

Application

FeF Cetrimide Ph.Eur. is a white or almost white, crystalline powder.

As a quaternary ammonium compound, FeF Cetrimide Ph.Eur., is a very efficient germicide which is active against most common micro-organisms, such as bacteria and fungi.

FeF Cetrimide Ph.Eur. is widely used in the pharmaceutical industry as an active ingredient (API) in antiseptic creams and ointments, and in the cosmetic industry as a preservative.

You can read more about Quats applications and uses here.

All deliveries of Cetrimide Ph.Eur. includes the following documentation and services

• Certificate of Suitability (CEP/COS)
• 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
• Change Notification Statement
• Pre-filled Supplier Questionnaire
• Impurity profile
• Description of the manufacturing process
• Process flowchart
• Packaging details
• Quality agreements

Specifications

Identification: Complies to Ph.Eur.

Appearance of solution: Max. as reference suspension 1, Max. as reference solution B9

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

Amines and amine salts: Max. 0.40 ml/g

Loss on drying: Max. 0.5% w/w

Sulphated ash: Max. 0.5% w/w

Assay (Mwt: 336.4): 99.0 – 101.0% w/w

Residual acetone: Max. 500 ppm

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: Certificate of Suitability (CEP), Drug Master File (DMF)

TSE: Does not contain materials of animal origin.

Solubility: Miscible with water or lower alcohols, such as methanol, ethanol and propanol in all ratios. Not miscible with benzene nor ether.

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

Density: Approx. 0.5 g/ml.

Melting point: 245 – 250 °C

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

Shelf life: 5 years.

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

You can find more information about our Cetrimide products here. Please contact us for information about price and delivery.