APISAL®

Pharmaceutical salt (API) in highest purity

Farmacja

For the exceptionally high requirements in pharmaceutical manufacturing processes, we produce pure pharmaceutical salt exceeding the purity requirements stipulated in the pharmacopoeias. All steps of production, analysis, and quality control comply with these strict principles.

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Security of supply

FDA / US DMF

CEP

GMP-ICH Q7

Informacje o produktach

For the exceptionally high requirements in pharmaceutical manufacturing processes, we produce pure pharmaceutical salt exceeding the purity requirements stipulated in the pharmacopoeias. All steps of production, analysis, and quality control comply with these strict principles. APISAL® is obtained from a particularly pure brine by a sophisticated evaporated salt process. APISAL® consists of sodium chloride of the highest quality, is of particular chemical purity and does not contain any additives.

Product properties

Low content of by minerals
Highest purity
Good Manufacturing Practice (GMP)—ICH Q₇
Complies with the requirements of the following pharmacopoeias: Ph. Eur., USP, BP, JP
CEP certificate
FDA registration
US Drug Master File (DMF)
Kosher and HALAL certification

Areas of application

Dialysis solutions, production of enteral and parenteral applications

All areas of application

Packaging

APISAL® sodium chloride is packaged and stored separately from all other production facilities under GMP/GDP conditions. It is produced in individual batches and subsequently analyzed. An individual certificate of analysis is sent with each delivery.