β- Cyclodextrin detection

A. Generally, the reagents and water used in this standard, unless otherwise specified, refer to analytical pure reagents and Grade III water as specified in GB/T6682. The standard solutions used in the experiment, impurity determination standard solutions, formulations, and products shall be prepared in accordance with the provisions of GB/T601, GB/T602, and GB/T603 unless otherwise specified. The solution used in the experiment refers to aqueous solution when no specific solvent is specified for preparation. A. 2 Identification test A.2.1 Specific rotation test Weigh 1 g of the sample and dissolve it in 100 mL of water. Measure according to the method specified in GB/T 613. The specific rotation should be between+160 ° and+164 *. A. 2.2 Chromatographic test In the 9-cyclodextrin content determination test, the retention time of the main peak in the sample solution chromatogram should be consistent with the retention time of the main peak in the standard solution chromatogram three β- Determination of cyclodextrin content (on a dry basis) A.3.1 Reagents and materials A.3.1.1 Methanol: Chromatographic purity A.3.1.2 Water: Grade I water according to GB/T 6682. A. 3.1.3 β Cyclodextrin standard: purity ≥ 99% A. 3.1.4 Internal standard solution: 20 mg/ml. glycerol solution, filtered through 0.45 pm microporous filter membrane. A. 3.2 Instruments and equipment: High performance liquid chromatograph: equipped with a differential refractive detector. A. 3.3 Reference Chromatographic Conditions A.3.3.1 Chromatographic Column: 10p with Bonded Aminopropylsiloxane as Filler μ M porous silica gel chromatographic column (4.6mmX25cm), or other equivalent chromatographic column. A. 3.3.2 Mobile phase: water+methanol=94+6. A.3.3.3 Column temperature: 30C. A. 3.3.4 Detector temperature; 35C. A. 3.3.5 Flow rate: 1.5 mL/min. A.3.3.6 Injection volume: 50 puL

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