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Description
The determination of sulphated ash is a compendial analytical method, as prescribed in the European Pharmacopoeia, for the quantification of inorganic impurities in pharmaceutical and chemical substances. This study describes the configuration and validation of a sulphated ash calculation method using the LabX laboratory software system.
The method enables automated data capture and calculation based on predefined variables and formulas, supporting data integrity throughout the data life cycle while ensuring that system-generated results comply with the ALCOA+ principle. Validation was performed independently using Microsoft Excel with experimental datasets from two samples subjected to repeated ignition. The results showed excellent agreement between LabX and Excel calculations, confirming the correctness and reliability of the configured method.
The study highlights the importance of proper configuration, traceability, and independent validation in ensuring compliance with regulatory requirements and improving analytical accuracy.