Analytical method scope expanded

The expansion means the laboratory now carries validated procedures across a fuller stability-indicating profile for its oral solid and injectable ranges. Related-substances methods characterise degradation products and process-related impurities, while dissolution testing provides a measure of drug release from oral solid dosage forms. Together with the assay and identification methods already in routine use, these additions allow a single analytical package to support batch release, ongoing stability studies and investigational testing under one validated framework.

“A stability-indicating related-substances method lets us quantify degradation directly, giving expiry dating a firmer analytical foundation than assay alone.”

Each method has been validated in line with the ICH Q2(R2) analytical-procedure guidance and the relevant United States Pharmacopeia general chapters. Related-substances and assay procedures are qualified for specificity, linearity, accuracy, precision and the limits of detection and quantitation appropriate to their purpose; dissolution testing follows the apparatus and acceptance-criteria conventions of USP <711>. Impurity acceptance thresholds are framed against the reporting, identification and qualification limits set out in ICH Q3A for drug substances and Q3B for drug products.

Validated related-substances methods are integral to Ergopharm's stability programme, which runs under ICH Q1A(R2) conditions: long-term storage at 25 °C/60% RH, intermediate at 30 °C/65% RH and accelerated at 40 °C/75% RH. Because these procedures are stability-indicating, they resolve and quantify degradation products that emerge over the shelf-life study, giving the laboratory a direct, numerical basis for setting and defending expiry dating rather than relying on assay alone.

The wider scope reduces reliance on external contract testing and shortens the analytical path from sampling to Certificate of Analysis, supporting Qualified Person release with data generated and reviewed in-house. All results are recorded and reviewed under ALCOA+ data-integrity principles, and any out-of-specification result is handled through the laboratory's established OOS, deviation and CAPA procedures. The practical benefit is tighter control of impurity and release-rate trends across the product range, with fewer hand-offs and clearer traceability from raw data to released batch.