Final answer:
The three standards for drug purity and content are Validation of Analytical Methods, Compliance with Regulatory Requirements like purity and effective labeling, and Adherence to Pharmaceutical Act Standards such as the Pure Food and Drug Act of 1906.
Step-by-step explanation:
The three standards for drug purity and content are important aspects of pharmaceutical analysis and quality control. The main purposes of these standards are to ensure the safety, efficacy, and consistency of pharmaceutical products. Here are the three standards:
- Validation of Analytical Methods: This includes a series of processes like intra and interday precision and accuracy assessment, effect of dilution on precision and accuracy, and assessment of extraction recovery for both the parent drug and its metabolites, as well as any internal standard used.
- Compliance with Regulatory Requirements: The Center for Drug Evaluation and Research enforces laws that guarantee the purity, effectiveness, and truthful labeling of the drugs. These requirements differ for new drugs, generic drugs, and over-the-counter drugs. Each type must undergo specific protocols and, in the case of new drugs, a New Drug Application (NDA).
- Adherence to Pharmaceutical Act Standards: Acts like the Pure Food and Drug Act of 1906 set various standards for drug purity and content, which include requiring drug makers to list ingredients and ensuring intensive inspection and sanitation of drug-making processes.
For accurate and precise drug content determination, a quality control chemist may use analytical techniques such as chromatography and detection conditions, full method validation (selectivity, linearity, lower limit of quantification (LLOQ), the limit of detection (LOD), accuracy, precision, and recovery), and stability testing. Stability assessments of stock solutions and sample extractions are integral to maintaining drug purity.