Introduction to Injection Grade Dextran 20 Low endotoxin Pharmacopoeia

Introduction to Injection Grade Dextran 20 Low endotoxin Pharmacopoeia

Dextran20is a kind of‌Pharmaceutical excipients‌, mainly used for‌Plasma substitutes‌Widely used in injections to expand blood volume and improve microcirculation. Here is a summary of its key information:

‌Basic properties‌

‌Chinese name‌: Dextran20

‌English name‌：Dextran 20

‌CASnumber‌：9004-54-0

‌molecular formula‌：(C₆H₁₀O₅)ₙ

‌source‌: Made from sucrose‌Leuconostoc mesenteroidesL.-M-1226Number bacteria‌（Leuconostoc mesenteroides）High molecular weight glucose polymer refined after fermentation‌

‌理化特性‌

‌appearance‌White or off white amorphous powder,‌Odorless and tasteless‌ ‌

‌solubility‌：‌Easy to dissolve in hot water‌，‌Insoluble in ethanol‌ ‌

‌specific rotation‌：+190°to+200°（25℃，10 mg/mLAqueous solution)‌

‌Weight average molecular weight（Mw）‌：‌16,000～24,000‌, belonging to small molecule dextran20

Youxuantanggan 20

Dextran 20

This product is Saccharomyces cerevisiae, a type of sugar producing bacterium with intestinal membrane morphologyL.-M-1226Number bacteria（Leuconostoc mesenteroides）The high molecular weight glucose polymer generated after fermentation is refined through processing. Dextran20The weight average molecular weight（Mw）Should be16 000~24 000.

【 Appearance 】 This product is a white powder; Odorless.

This product is soluble in hot water and insoluble in ethanol.

Take this product for specific rotation, accurately weigh it, dissolve it in water and dilute it quantitatively to make each one1mlModerate content10mgThe solution, in25℃When measured in accordance with the law (General Principles)0621）The specific rotation is+190°to+200°.

【 Identification 】 Take this product0.2gAdd water5mlAfter dissolution, add the test solution2mlAdd a few drops of copper sulfate solution to generate a light blue precipitate; After heating, it turns into a brown precipitate.

【 Inspection 】 Molecular Weight and Molecular Weight Distribution According to Molecular Exclusion Chromatography (General Rules)0514）Measurement.

Take an appropriate amount of the test sample solution, dissolve it in the mobile phase, and dilute it to make each sample1mlModerate content10mgShake the solution and let it sit overnight.

Reference solution extraction4~5Dissolve and dilute a known molecular weight dextran reference substance in the mobile phase to prepare each1mlEach containing10mgThe solution.

System suitability solution（1）Take an appropriate amount of glucose, dissolve it in mobile phase and dilute it to make each1mlModerate content10mgThe solution.

System suitability solution（2）Take pectin2000Moderate amount, dissolve and dilute with mobile phase to make each1mlModerate content10mgThe solution.

Chromatographic conditions using hydrophilic spherical polymers as fillers（TSK G PWXLColumnShodex OHpak SB HQColumn or other suitable chromatographic column); with0.71%Solution (containing0.02%Sodiumproclin 300Or other suitable preservatives) as the mobile phase; Column temperature is35℃The flow rate is per minute0.5mlDifferential refractive index detector; injection volume20μl.

System Applicability Requirements System Applicability Solution（1）In the chromatogram, the retention time of glucose istTSystem Applicability Solution（2）In the chromatogram, glucan2000The retention time ist0The retention time of the main peak in the chromatogram of the test solution and the reference solutiontRAll should be intTandt0between. The number of theoretical plates calculated based on the glucose peak shall not be less than5000In the chromatogram of the reference solution, with retention time as the x-axis and the logarithm of peak position molecular weight as the y-axis, useGPCThe software calculates a regression equation once, and the correlation coefficient should not be less than0.990.

Measurement method: Precisely measure the test solution and control solution, inject them into the liquid chromatograph separately, and record the chromatogram. fromGPCThe software calculates the regression equation of the reference solution and the weight average molecular weight and molecular weight distribution of the test sample separately.

The limit weight average molecular weight should be16 000~24 000，10%The weight average molecular weight of the macromolecular portion shall not exceed70 000，10%The weight average molecular weight of the small molecule portion shall not be less than3500.

Chloride takes this product0.10gAdd water50mlAfter heating and dissolving, let it cool and take the solution10mlInspect in accordance with the law (General Principles)0801）, compared to standard sodium chloride solution5mlThe comparison of the prepared control solution should not be thicker（0.25%）.

Nitrogen extract from this product0.20g, set up50mlAdd sulfuric acid to the Kjeldahl flask1mlHeat and digest until the test sample turns into a black oily substance, then let it cool and add30%solution2mlHeat and digest until the solution is clear (if not clear, add the above hydrogen solution)0.5~1.0mlContinue heating and cool down until20℃Below, add water10mlAdd dropwise5%The solution becomes alkaline and moves to50mlIn the colorimetric tube, wash the flask with water, merge the washing solution into the colorimetric tube, dilute with water to the mark, and slowly add alkaline test solution2mlAdd and shake well as needed (keep the solution temperature at20℃(Below); If color is visible, compare it with standard ammonium sulfate solution (accurately weighed)105℃Ammonium sulfate dried to constant weight0.4715g, set up100mlDissolve in water and dilute to the mark in a volumetric flask, mix well, and use as a storage solution. Accurately measure the storage solution before use1ml, set up100mlDilute with water to the mark in a volumetric flask and shake well. each1mlequivalent to10μgofN）1.4mlAdd sulfuric acid0.5mlComparing the colors processed by the same method, they should not be darker（0.007%）.

Dry weight loss: Take this product, in105℃dry6Hours, weight loss must not exceed5%(General rules)0831）.

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

The residue left under the ignition residue of heavy metals shall be inspected in accordance with the law (General Rules)0821The second method requires that the content of heavy metals should not exceed one million

Introduction to Injection Grade Dextran 20 Low endotoxin Pharmacopoeia