Final answer:
A medical reference summarizing drug purity standards discusses the extensive bioanalysis and method validation required in the drug development process, including the history of regulatory acts like the Pure Food and Drug Act of 1906. The high cost of drugs can be attributed in part to the substantial loss of material during their purification.
Step-by-step explanation:
A medical reference summarizing standards of drug purity typically deals with the rigorous steps and procedures involved in ensuring that pharmaceuticals meet specific standards before they can be deemed safe for consumption. This involves bioanalysis and method validation during drug discovery and development, which includes the finalization of extraction, chromatographic, and detection conditions, along with a full validation process that tests for selectivity, linearity, lower limit of quantitation (LLOQ), limit of detection (LOD), accuracy, precision, recovery, and stability experiments for parent drugs and metabolites.
The Pure Food and Drug Act of 1906 was an early example of legislation that required drug makers to meet certain purity standards. Additionally, the act mandated that drug makers list ingredients in their products, which was a response to muckraking exposés that highlighted issues with adulterated foods and dangerous patent medicines.
Only about one-fourteenth of the original material may be turned into a purified drug, which is one reason for the high cost of pharmaceuticals. The loss of material during the purification process, which ensures the production of high-purity pharmaceuticals, ultimately contributes to the overall expenses.