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There are also restrictions and limitations on coverage for these drugs
Stability testing depth Brand-name stability testing follows ICH Q1A guidelines, involving multiple storage conditions (25 degrees Celsius/60% relative humidity for long-term, 40 degrees Celsius/75% relative humidity for accelerated), multiple time points (0, 3, 6, 9, 12, 18, 24 months), and multiple analytical methods (HPLC for potency, size exclusion chromatography for aggregation, pH measurement, visual inspection, and more)
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