Solutions

FeF Benzalkonium Chloride (BKC) Ph.Eur., USP/NF, JP

CAS No. 8001-54-5.

Our Benzalkonium Chloride (BAC / BAK / BKC) product consists of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%). Contains approx. 95% active ingredients.

BKC is manufactured in accordance with the cGMP Guideline ICH Q7 for Active Pharmaceutical Ingredients. Multicompendial analyses according to the current European (Ph.Eur.), United States (USP/NF) and Japanese (JP) Pharmacopoeias. Now also analysed according to the Chinese Pharmacopoeia (ChP).

The appearance of the product is clear, or white to yellowish-white solid or viscous liquid and may contain yellowish-white fragments.. The density of Benzalkonium Chloride (BKC) Solution is approx. 0.98 g/ml.

Chain length: 60-70% w/w C12, 30-40% w/w C14 and Max. 5% w/w C16.

Item number: 7800012

Packaging size: 1kg bottle (also available in 5kg bottle – item number 7800013)

Application

FeF Benzalkonium Chloride (BKC) Ph.Eur., USP/NF, JP is a viscous liquid of quaternary ammonium compounds.

FeF BKC Ph.Eur., USP/NF, JP is a very efficient germicide which is active against most common micro-organisms, such as bacteria, fungi, algae and enveloped viruses. FeF BKC Ph.Eur., USP/NF, JP is widely used in pharmaceuticals as the active ingredient (API) due to its anti-microbial effect and as an Excipient because of its preserving properties.

5 kg bottle

7800013

1 kg bottle

7800012

Following documentation and services are included in all deliveries

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

Technical information

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

ISO45001 Occupational health and safety management.

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)

BSE/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. 0.98 g/ml.

Packaging: 1 kg rectangular HDPE plastic containers with tamper proof LDPE Caps or 5 kg round PP plastic containers with tamper proof PP lids.

Shelf life: 5 years.

Storage: Store at temperatures above 15°C. Store protected from excessive heat. May be a liquid, paste or solid depending on the storage conditions.

SDS documents