Krull I S, Goff U, Silvergleid A, Fine D H
Arzneimittelforschung. 1979;29(6):870-4.
73 pharmaceutical products, consisteing of both prescription and over-the-counter drugs have been analyzed by gas chromatography-thermal energy analysis (GC-TEA) and high-pressure liquid chromatography-thermal energy analysis (HPLC-TEA) for the presence of N-nitroso compound contaminants. The methods used were designed to detect both volatile and non-volatile N-nitroso compounds at levels down to 1 ng/g (1 ppb). Results presented here indicate that N-nitroso compound impurities are absent from the majority of the products tested. However, for 3 of the drugs, our analysis suggests the possible presence of N-nitroso compounds at levels up to 81 ng/g (81 ppb). The identity of the suspect N-nitroso compounds have not yet been established. In the case of the over-the-counter drugs, two of these have been shown to contain TEA responsive materials (126 ppb, 406 ppb), that may appear to be O-nitroso compounds rather than N-nitroso.
采用气相色谱 - 热能分析（GC - TEA）和高压液相色谱 - 热能分析（HPLC - TEA）对73种药品（包括处方药和非处方药）进行分析，以检测其中是否存在N - 亚硝基化合物污染物。所采用的方法旨在检测挥发性和非挥发性N - 亚硝基化合物，检测限低至1 ng/g（1 ppb）。此处给出的结果表明，大多数受试产品中不存在N - 亚硝基化合物杂质。然而，对于其中3种药品，我们的分析表明可能存在含量高达81 ng/g（81 ppb）的N - 亚硝基化合物。可疑N - 亚硝基化合物的身份尚未确定。在非处方药中，其中两种已被证明含有对TEA有响应的物质（126 ppb，406 ppb），这些物质可能看起来是O - 亚硝基化合物而非N - 亚硝基化合物。
