Strong Cetrimide

FeF Strong Cetrimide Solution 40% BP Pharma with isopropyl alcohol

CAS No. 1119-97-7.

FeF Strong Cetrimide Solution 40% BP Pharma with isopropyl alcohol consists of dodecyl trimethyl ammonium bromide (approx. 20%) and trimethyl tetradecyl ammonium bromide (approx. 80%). FeF Strong Cetrimide Solution 40% BP Pharma contains approx. 7.5% v/v isopropyl alcohol.

The product is manufactured in accordance with the cGMP Guideline ICH Q7 for Active Pharmaceutical Ingredients and Analysed according to the current British Pharmacopoeia (BP).

The appearance of the product is clear and colourless to slightly yellow, viscous solution. The density of Strong Cetrimide Solution 40% BP Pharma with isopropyl alcohol is approx. 1.0 g/ml.

Chain length: C12: 15 – 25% w/w, C14: 75-85% w/w, C16: Max. 5% w/w.

Strong Cetrimide Solution is also known as Cetrimide / Cetrimoni bromidum / Tetradecyl trimethyl ammonium bromide (TTAB).

Applications

FeF Strong Cetrimide Solution 40% BP Pharma is an aqueous solution of quaternary ammonium compounds.

FeF Strong Cetrimide Solution 40% BP Pharma is an efficient germicide which is active against most common micro-organisms, such as bacteria and fungi. FeF Strong Cetrimide Solution 40% BP Pharma is widely used as the active ingredient (API) in pharmaceutical antiseptic liquids due to its anti-microbial effect.

You can read more about Quats applications and uses here.

All deliveries of Strong Cetrimide Solution 40% BP Pharma with IPA 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
• Change Notification Statement
• Pre-filled Supplier Questionnaires
• Impurity profile
• Description of the manufacturing process
• Process flowchart
• Packaging details
• Quality agreements

Specifications

Identification: Complies to BP

Appearance: Clear and colourless to slightly yellow, viscous solution

Chain length: C12: 15 – 25% w/w, C14: 75-85% w/w, C16: Max. 5% w/w

Acidity or alkalinity: Max. 1.0 ml 0.1M HCl or NaOH

Miscibility with ethanol: Clear

Neutral substances: Max. 0.4 g

Non-quaternised amines: Max 2.4% w/w (content of Cetrimide)

Isopropyl alcohol: Max. 10.0% v/v

Assay (Mwt: 336.4): 38.0 – 42.0% w/v

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 (ESMF/ADMF)

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. 1.0 g/ml.

Packaging: Is filled into 220 litre HDPE drums with a sealable closing system.

Shelf life: 5 years.

Storage: Store at temperatures above 15°C. Store protected from excessive heat. May form a solid gel or a viscous precipitate at low temperatures.

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