Arzneibuch

Arzneibuch is the term used for an official pharmacopoeia, a reference work that sets the standards for medicines, active substances, dosage forms, and related materials. It serves as the legal and technical basis for quality control in pharmaceutical manufacturing, dispensing, and regulation. Pharmacists, manufacturers, and regulatory authorities rely on its monographs and general chapters to ensure the safety, efficacy, and consistency of medicinal products.

A typical Arzneibuch contains monographs for medicinal substances and finished dosage forms, as well as entries for excipients and ancillary materials. It also includes general chapters with methods for identification, assay, impurity and contaminant testing, dissolution, microbiological tests, and stability assessments. Packaging, labeling, storage conditions, and handling instructions are often specified. The document provides limits and acceptance criteria for quality attributes, and it outlines procedures for documentation and compliance.

Regulatory role and scope: Medicines marketed within a country or region must meet the standards published in the relevant Arzneibuch. In German-speaking countries, the Deutsches Arzneibuch is the national reference, while the European Pharmacopoeia (Ph. Eur.) serves as a harmonized standard across the European Union. National authorities may incorporate these standards into licensing and quality-control requirements.

Global context: Numerous pharmacopoeias exist worldwide, such as the United States Pharmacopeia (USP), the British Pharmacopoeia, and the Japanese Pharmacopoeia. These documents are periodically updated to reflect new scientific knowledge, methods, and regulatory needs, and efforts toward harmonization aim to align testing and specifications across jurisdictions.