Introduction of the Updated Content of Tests of Fats and Fatty Oils in the Chinese Pharmacopoeia 2020 Edition and Determination Examples of Trans Fatty Acids

OBJECTIVE To introduce updated content in the general principle 0713 "tests of fats and fatty oils" in Chinese Pharmacopoeia 2020 Edition. METHODS Compared the updated items with foreign pharmacopoeias, introduced the concepts, measurement principles and applications of the updated items, and determined the trans fatty acids in soybean oil(for injection) using the trans fatty acid determination method. RESULTS The updated content unsaponifiable matter, alkaline impurities, fatty acid composition, anisidine value, sterol composition and trans fatty acids reflected the new concepts, new methods and new technologies in the field of test of fat and fatty oil in China in recent years. Verification of trans fatty acid determination method showed that typical trans fatty acid methyl esters had good linear relationship within the ranges of 20-450 μg·mL^-1(all R² ≥ 0.998 0), and the RSD of repeatability test was of 0.7%^-10.2%, the limit of detection was of 5^-10 μg·mL^-1 and the limit of quantitation was of 15-34 μg·mL^-1. The results of 20 batches of soybean oil(for injection) based on the normalization method were basically consistent with the internal standard method. The content of trans fatty acids in the products of domestic enterprises was higher than that of foreign enterprises. CONCLUSION This edition of the general principle closely follows the development trend of the international advanced pharmacopoeias, and at the same time has achieved self-innovation and breakthroughs. Its implementation is beneficial to better improve the technical ability and management level of ester substance inspection. The trans fatty acid determination method can be used to determine the content of trans fatty acids in soybean oil(for injection).