Chlorhexidine salts: Use in pharmaceutical products

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

REACH registration no. 01-2119946568-22-0005

Chlorhexidine HCl

Chlorhexidine HCl is a high quality antiseptic, disinfectant and preservative used for a broad field of indications.

Uses

Antiseptic
Chlorhexidine HCl is typically used in combination with other APIs for sore throat tablets.

Preservative
In the cosmetic field Chlorhexidine HCl is used as a preservative in creams, ointments and gels.

Regulatory Status

API (Ph. Eur.)

• GMP (Good Manufacturing Practice) / FDA approved
• DMF (Drug Master File) issued 2011 No. 25070

Medical Devices
Chlorhexidine HCl can also can be used as disinfectants for medical devices according to the EU regulation n°2017/745.

Cosmetic
Chlorhexidine HCl 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
Drums of 25 kg, other packaging on request

Chlorhexidine Acetate

Chlorhexidine Acetate is a high quality antiseptic used for a broad field of indications.

Uses

Veterinary uses
Chlorhexidine Acetate is also used for many veterinary applications in certain geographical areas instead of Chlorhexidine Gluconate.

Others
Chlorhexidine Acetate is used to manufacture antacid tablets.

Regulatory Status

API (Ph. Eur.)

• GMP (Good Manufacturing Practice) / FDA approved

Medical Devices
Chlorhexidine Acetate can also can be used as disinfectants for medical devices according to the EU regulation n°2017/745.

Cosmetic
Chlorhexidine Acetate 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
Drums of 25 kg, other packaging on request

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