Pharmaceutical grade compressible sucrose 25kg standard, Pharmacopoeia 2025

Pharmaceutical grade compressible sucrose 25kg standard, Pharmacopoeia 2025

Compressible sucrose

Keyaxing Zhetang

Compressible Sugar

This product is made by co crystallization of sucrose and other excipients, such as maltodextrin; It can also be produced by dry granulation process. Calculated as dry product, containing sucrose（C12H22O11）Should be95%～98%.

This product may contain starch, maltodextrin, invert sugar, and appropriate flow aids.

【 Appearance 】 This product is a white or off white crystalline powder or small particles.

This product is highly soluble in water.

【 Identification 】（1）Under the content determination item, the specific rotation of the non conversion solution shall not be less than+62.6°The acid conversion solution is left-handed.

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

[Inspection] Chloride: Take this product0.20gDissolve in water to form25mlInspect in accordance with the law (General Principles)0801）, compared to standard sodium chloride solution2.5mlThe comparison of the prepared control solution should not be thicker（0.0125%）.

Sulfate takes this product1.0gInspect in accordance with the law (General Principles)0802）, compared to standard potassium sulfate solution1.0mlThe comparison of the prepared control solution should not be thicker（0.01%）.

Dry weight loss: Take this product, in105℃dry4Hours, weight loss must not exceed1%(General rules)0831）.

Take the residue from the ignition and inspect it according to the law (General rules)0841）The remaining residue shall not be passed over0.1%.

Calcium salt for this product1.0gAdd water5mlDissolve and add ammonium oxalate test solution1ml, 1The solution should remain clear within minutes.

Heavy metals in this product4.0gAdd water20mlDissolve, add0.1mol/L盐酸溶液1mlMake it in moderation with water25mlInspect in accordance with the law (General Principles)0821The first law stipulates that the content of heavy metals shall not exceed 5 parts per million.

taken from105℃dry4About hours of this product26gPrecise weighing and positioning100mlAdd saturated lead acetate solution to the volumetric flask0.3mlwith water90mlShake to dissolve, dilute with water to the mark, shake well, and spread diatomaceous earth flat on a filter plate8gUse a Buchner funnel, filter under reduced pressure, and discard the initial filtrate20mlAccurately measure the continuous filtrate25mlTwo copies, keep two each50mlTake one of the measuring bottles and slowly add hydrochloric acid solution（12）6mlShake well and then add water10mlShake well before placing60℃Water bath, continuous shaking3Minutes and continue heating7Minutes, immediately cool down to20℃Dilute with water to the mark and mix well; Cool the other bottle to20℃Dilute with water to the mark and shake well. Put two measuring bottles in20℃maintain30After minutes, measure the specific rotation according to the law (general rules)0621）Calculate according to the following formula:

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In the formulaαoandHey!The specific rotation of non conversion and acid conversion solutions are respectively.

[Category] Diluents and Sweeteners.

【 Storage 】 Sealed storage.

Pharmaceutical grade compressible sucrose 25kg standard, Pharmacopoeia 2025