500g/bottle pharmaceutical grade trehalose 2025 edition pharmacopoeia quality standard

500g/bottle pharmaceutical grade trehalose 2025 edition pharmacopoeia quality standard

trehalose

C₁₂H₂₂O₁₁　342.30　[99-20-7]C₁₂H₂₂O₁₁·2H₂O　378.33　[6138-23-4]

This product is hydrolyzed by edible grade amylase. For two pyranose ring glucose moleculesNon reducing disaccharides formed by 1,1-glycoside bonds can be divided into anhydrous and dihydrate forms. Calculated as anhydrous substance, containing C₁₂H₂₂O₁₁should be98.0% to 102.0%.

Anhydrous trehalose is soluble in water and almost insoluble in methanol or ethanol. Dihydrate trehalose is soluble in water, slightly soluble in methanol, and almost insoluble in ethanol.

Take this product for specific rotation, accurately weigh it, dissolve it in water and dilute it quantitatively to make each one1ml contains approximately 100mg of solution, determined according to the method（General rule0621）The specific rotation is+197 ° to+201 °.

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

Take this product separately and measure the moisture content）Determination, the moisture content should be9.0%～11.0%； If it is anhydrous, the moisture content should not exceed 1.0%.

Take this product from the residue of ignition and inspect it according to the law（General rule0841）The remaining residue shall not be passed over0.1%.

Heavy metals in this product4.0g， After dissolving in 23ml of water, add 2ml of acetate buffer solution (pH 3.5) and check according to the method（General rule0821The first law stipulates that the content of heavy metals shall not exceed 5 parts per million.

Microbial limit: Take this product and inspect it according to the law（General rule1105andGeneral rule1106）, everyThe total number of aerobic bacteria in 1g of the test sample shall not exceed 10³cfu， The total number of molds and yeasts shall not exceed 10²cfu， Do not detect Escherichia coli; Salmonella should not be detected in every 10g of the test sample.

Bacterial endotoxin (for injection): Take this product and check it according to the law（General rule1143）, everyThe amount of endotoxin in 1mg trehalose should be less than 0.05EU.

According to high-performance liquid chromatography method（General rule0512）Measurement.

[Category] Flavoring agents, sweeteners, freeze-drying protectants, diluents, thickeners, and moisturizers, etc.

【 Storage 】 Store in a sealed, cool, and dry place.

500g/bottle pharmaceutical grade trehalose 2025 edition pharmacopoeia quality standard