Chlorhexidine salts: Use in pharmaceutical products

Chlorhexidine is approved for use as a biocide according to the ECHA active substance list.

Chlorhexidine Digluconate 20%

Chlorhexidine Digluconate 20% is a high-quality antiseptic for a wide range of indications.

Uses

In different applications as anti-infective agents and desinfectant.

Topical use

• Surgical scrub and antiseptic hand rinse for healthcare personnel
• Skin cleanser for preoperative skin preparation, skin wound and general skin cleanser for patients

Oral use

• Oral rinse: Antibacterial dental rinse for gingivitis treatment
• Against periodontitis

Veterinary use

• Effective protection against mastitis pathogens for prevention of bovine mastitis
• Used in the general livestock hygiene
• The typical concentration of Chlorhexidine Digluconate 20% as desinfectant is 0,5 – 4%

Regulatory Status

API (Ph. Eur.)

• EU-GMP (Good Manufacturing Practice) / FDA approved
• CEP
• DMF (Drug Master File) issued 2006 No. 21946

Biocide (BPR)

Chlorhexidine Digluconate 20% is an active substance listed under the EU BPR regulation n°528/2012. Our partner RN Laboratories is an approved supplier according to article 95 of regulation n° 528/2012 for following product types:

• Product type 1: Human hygiene
• Product type 2: Disinfectants, that are not intended for direct application to humans or animals
• Product type 3: Veterinary and animals hygiene

Medical Devices

Chlorhexidine Digluconate 20% can also can be used as disinfectants for medical devices according to the EU regulation n°2017/745.

Cosmetic

Chlorhexidine Digluconate 20% is listed in the EU regulation n° 1223/2009. It can be used in cosmetics as a preservative with a maximum concentration of 0.3%.

Packaging

• IBC’s of 1000 kg, drums of 200 kg and 50 kg