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Hazard Information

Questions And Answer

• Appearance

  White to Almost white powder to crystal;

• Detection Method

  Octadecanedioic acid mono-tert-butyl ester (18-(tert-Butoxy)-18-oxooctadecanoic Acid) is a preparation raw material of the side chain of the somaglutide. The technical scheme is that a purchased raw material with the main component of octadecanedioic acid mono-tert-butyl ester is detected, whether the purity of the raw material substance is within a quality control standard or not is verified, and the purpose of detecting the purity of the raw material substance is to ensure the synthesis yield of a finished product of the side chain of the later-stage somnautide. For process reasons, raw materials usually comprise impurities such as octadecanedioic acid, tetradecanedioic acid mono-tert-butyl ester, hexadecanedioic acid mono-tert-butyl ester, octadecanedioic acid mono-methyl ester and octadecanedioic acid mono-methyl ester, and the current detection method mainly bases on the general rule of the four departments of the 2015 version of Chinese pharmacopoeia, but no method for separately detecting the octadecanedioic acid mono-tert-butyl ester exists, and the product is a long-chain alkane series, has long retention time in a chromatographic column and is difficult to elute in a proper time. A method for testing octadecane dioic acid mono-tert-butyl ester comprises the following steps: S1. preparing a test solution and a system suitability solution; S2. using high performance liquid chromatography for detection, the chromatographic conditions comprising: using Agilent ZORBAX SB-C18 as a chromatographic column, using 0.1% phosphoric acid aqueous solution as mobile phase A, using acetonitrile as mobile phase B, performing gradient elution, the column temperature being 35°C, the flow rate being 1.0 mL/min, and the detection wavelength being 210 nm; S3. calculating the purity of the test sample by the area normalization method, and observing the sizes of known impurities and other unknown impurities in the chromatogram. ;

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