IGF::OT::IGF: ANALYTICAL CHEMISTRY AND STABILITY TESTING OF TREATMENT DRUGS FOR SUBSTANCE USE DISORDERS. N01DA-14-8918. PERIOD OF PERFORMANCE: AUGUST 4, 2014 TO AUGUST 3, 2015.

开发或改进政府提供的原料药和药品的检测方法，以确保纯度、鉴定和强度，并对其进行物理和化学表征，并验证原料药和成品剂型开发的分析方法，以FDA可接受的格式，根据需要包括方法特异性、线性、准确性、精密度、检出限、定量限、回收率、坚固性和样品稳定性的文件。

Develop or improve test methods for drug substances and drug products provided by the Government to ensure the purity, identify and strength, and to characterize them physically and chemically and to validate analytical methods developed for drug substances and finished dosage forms to include documentation, as needed, of method specificity, linearity, accuracy, precision, detection limit, quantitation limit, recovery, ruggedness, and sample stability in a format acceptable to the FDA.