Stability testing is utilized to determine if the quality of a drug substance or drug product is altered over time by various environmental factors, such as light, temperature, and humidity. A drug “substance,” often referred to as an Active Pharmaceutical Ingredient (API), is defined as the unformulated material that may subsequently be formulated with excipients to produce a dosage form. A drug “product” is the formulated mixture of the drug substance and excipients comprising the final marketed dosage form.
For a drug substance, stability testing determines the “re-test period,” the timeframe during which the drug substance is expected to remain within its specification, and therefore can be used in the manufacture of a given drug product. After the established re-test period has elapsed, a drug substance can only be used if additional specification testing is performed, the material passes inspection, and the substance is distributed soon after meeting acceptance criteria.
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