Viitevalmiste

Viitevalmiste, in English often translated as reference preparation, is a well-characterized material used as a standard to calibrate analytical methods, validate procedures, and ensure traceability of results. It can take the form of a certified reference material, a standard solution, or other reference substances provided by producers or laboratories. Each lot is evaluated for identity and purity, and a certificate of analysis accompanies the material stating the assigned value and the associated measurement uncertainty.

Viitevalmiste serves to provide a known quantity of the target analyte, enabling accurate quantification through calibration curves, method validation, and routine quality control. It supports interlaboratory comparability and regulatory compliance across sectors such as pharmaceutical, clinical, environmental, and food testing.

Production and characterization involve controlled manufacturing processes and validated analytical characterization. Key properties include chemical identity, purity, content, stability, and homogeneity. Documentation typically includes the material name, lot or batch number, certificate or CRM (certified reference material) number, expiry date, and recommended handling and storage conditions. A certificate of analysis records the assigned value, uncertainty, and traceability to higher-order standards.

Types commonly include primary reference materials, certified reference materials, and in-house reference materials used for internal QA. Handling and storage requirements aim to preserve integrity, often specifying temperature, light protection, and humidity controls; reconstitution and use follow the certificate’s instructions to maintain accuracy.

Regulatory and quality frameworks govern the production and use of viitevalmiste, with guidance from pharmacopoeias and international standards for reference materials. Proper documentation and traceability to higher-order units are essential for regulatory acceptance and reliable analytical results.