Pharmaceutical grade sucrose octaacetate 1kg pharmacopoeia filing

Pharmaceutical grade sucrose octaacetate 1kg pharmacopoeia filing

Sucrose Octaacetate

Zhetang Bacusuanzhi

Sucrose Octaacetate

dandelion

C28H38O19678.59

[126-14-7]

This product isβ-D-Fructofuranosyl-α-D-Pyroglucoside Octaacetate. Calculated as anhydrous substance, includingC28H38O19no less than98%.

【 Appearance 】 This product is a white powder.

This product is easily soluble in methanol, soluble in ethanol, and extremely slightly soluble in water.

Melting point of this product (general rules)0612）Not less than78℃.

【 Identification 】（1）Take this product0.5gAdd n-butanol20mland5%sodium chloride solution20mlThe mixture (preheated to)40～60℃）Shake to dissolve, let it stand, separate the water layer, and reuse the n-butanol layer5%sodium chloride solution40ml(Preheat to40～60℃）Divide2Wash again, take about the n-butanol layer2mlPlace it in a test tube, tilt the tube, and slowly add anthrone test solution along the wall3mlTo form a layered structure, place60℃water bath heating3In minutes, blue to green appears at the contact surface between the two liquid layers.

（2）In the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with that of the main peak of the reference solution.

（3）The infrared absorption spectrum of this product should be consistent with the spectrum of the reference substance (General rules)0402）.

[Check] Acidity: Take this product1gAdd neutral ethanol20mlDissolve and add phenolphthalein indicator solution2Drop, add0.1mol/L*Solution2Drop, the color of the solution should turn red.

Take an appropriate amount of this product, accurately weigh it, and add acetonitrile to the substance-Water（75∶25）Dissolve and quantitatively dilute to make each1mlModerate content20mgThe solution is used as the test sample solution.

Accurately measure the test solution1ml, set up100mlIn a volumetric flask, use acetonitrile-Water（75∶25）Dilute to the mark, shake well, and use as a control solution.

Accurately measure the reference solution1ml, set up10mlIn a volumetric flask, use acetonitrile-Water（75∶25）Dilute to the mark, shake well, and use as a sensitivity solution.

According to the General Principles of High Performance Liquid Chromatography (HPLC)0512）Measurement. Using octadecylsilane bonded silica gel as filler and acetonitrile as mobile phaseAUsing water as the mobile phaseBThe detection wavelength is210nmThe column temperature is30℃Perform gradient elution according to the table below. Take sensitivity solution20μlInject into the liquid chromatograph, the signal-to-noise ratio of the sucrose octaacetate peak should be greater than10Accurately measure the test solution and control solution separately20μlInject into the liquid chromatograph separately and record the chromatogram until the retention time of the main peak2Twice. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak should not be greater than that of the main peak of the control solution（1%）The sum of the peak areas of each impurity shall not exceed the peak area of the main peak of the control solution2.5Multiple times（2.5%）.

dandelion

Moisture content: Take this product and follow the moisture determination method (general rules)0832The First Law1）Measurement, moisture content should not exceed1%.

Burning residue: Take this product1.0gInspect in accordance with the law (General Principles)0841）The remaining residue shall not be passed over0.5%.

According to the high-performance liquid chromatography method (general rules)0512）Measurement.

Chromatographic conditions and system suitability test using octadecylsilane bonded silica gel as filler; Acetonitrile-Water（75∶25）For the mobile phase; The detection wavelength is210nmThe number of theoretical plates calculated based on sucrose octaacetate shall not be less than2500.

Determination method: Take the approximate amount of this product0.5gPrecise weighing and positioning100mlDissolve and dilute the mobile phase to the mark in a volumetric flask, shake well, and use as the test solution. measure precisely20μlInject into the liquid chromatograph and record the chromatogram. Take another reference substance of sucrose octaacetate and measure it using the same method. Calculated by peak area using the external standard method, it is obtained.

[Category] Alcohol Denaturator.

【 Storage 】 Sealed storage.

Pharmaceutical grade sucrose octaacetate 1kg pharmacopoeia filing