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Publication of the revised national drug standard for riboflavin sodium phosphate for injection

Carrie Mar 05,2020 Share this post:

This product is a sterile lyophilized product of riboflavin sodium phosphate. Calculated based on the average loading. Riboflavin-containing sodium phosphate should be calculated from 90% to 110% of the labeled amount.

Properties This product is yellow or orange yellow loose block or powder


COP vials

Identify

(1) Take an appropriate amount of this product (approximately 1mg of riboflavin), add water to 100ml, the solution shows yellow and strong yellow-green fluorescence under transmitted light; add hydrochloric acid or sodium hydroxide test solution, and the fluorescence disappears.

(2) The retention time of the main peak of the test solution should be consistent with the retention time of the main peak of riboflavin sodium phosphate in the system suitability solution.

(3) Take an appropriate amount of this product (approximately 0.1g of riboflavin), add 10ml of nitric acid, evaporate to dryness in a water bath, burn, add 5ml of water to dissolve the residue, filter if necessary, and identify the sodium salt of the filtrate. Differential reaction with phosphate (Chinese Pharmacopoeia 2015 Edition Four General Rules 0301).

Check the pH Take this product, add water to make a solution containing about 5mg of riboflavin per 1ml, and measure it according to law (Chinese Pharmacopoeia 2015 Four General Rules 0601). The pH should be 5.0 ~ 6.5.

Clarity of the solution: Take 5 bottles of this product and add water to make a solution containing about 5mg of riboflavin per 1ml. The solution should be clear; if it is turbid, it should be mixed with No. 1 turbidity standard solution (China Pharmacopoeia 2015 Edition Four General Rules One method) comparison must not be thicker.

Take flavin (approximately 25.6mg of riboflavin), add 10ml of non-alcohol chloroform, shake for 5 minutes, filter, and filter the filtrate according to UV-Vis spectrophotometry (Chinese Pharmacopoeia 2015 Edition Four General Rules 0401) Measured at a wavelength of 440nm, the absorbance must not exceed 0.030.

Relevant substances were determined according to high performance liquid chromatography (Chinese Pharmacopoeia 2015 Edition Four General Rules 0512).

Test solution Take the contents under the difference in the loading amount, accurately weigh, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.2mg of riboflavin per 1ml.

Control solution Precisely measure 2ml of the test solution, place it in a 100ml volumetric flask, dilute to the mark with mobile phase, and shake well.

For reference solution, take approximately 10mg of riboflavin reference, accurately weigh and place in a 50ml volumetric flask, add 1ml of hydrochloric acid to dissolve, dilute to the mark with mobile phase, shake well, take 1mg precisely, place in 10ml volumetric flask, and use mobile phase Dilute to scale and shake well.

System suitability solution Take 10mg of riboflavin sodium phosphate mixed reference substance, put it in a 50ml volumetric flask, add mobile phase to dissolve and dilute to the mark, and shake well.

Sensitivity solution Precisely measure 5ml of the control solution, place it in a 100ml volumetric flask, dilute to the mark with mobile phase, and shake well.


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