Medical grade maltodextrin experiment application for research and development test

Medical grade maltodextrin experiment application for research and development of maltodextrin Maiya Hujing Maltodextrin [9050-36-6] This strain of starch is refined by enzymatic or acid hydrolysis
.

【Properties】This product is white or off-white powder or granules; Slightly smelly
.

This product is easily soluble in water and almost insoluble
in absolute ethanol.

【Identification】Take about 1g of this product, add 10ml of water to dissolve, slowly drop into the alkaline copper tartrate test solution, heat, that is, generate red precipitation
.

【Check】Acidity Take 2.
0g of this product, add 10ml of water to dissolve, and determine according to law (General 0631), the pH value should be 4.
5 ~ 6.
5
.

Insoluble matter in water Take 5.
0g of this product (according to the dry product), put it in a beaker, add 35 ~ 40 ° C water 50ml dissolved, while hot with 105 ° C dried to constant weight No.
3 vertical melting crucible filtered, beaker with 35 ~ 40 ° C water 50ml washed in parts, filtered, filter residue at 105 ° C to constant weight, the residual residue shall not exceed 1.
0%.
Protein Take about 1g of this product, precision weighing, placed in a Kai flask, add potassium sulfate 1.
5g and copper sulfate 0.
15g, slowly add 5ml of sulfuric acid (if necessary, appropriate supplementation of sulfuric acid to complete digestion), according to the nitrogen determination method (general 0704 second method or third method) to determine the nitrogen content, and then multiply by a coefficient of 6.
25 to obtain
.

Protein content must not exceed 0.
1%.
Sulfur dioxide Take 5g of this product, precision weighing, placed in a 250ml iodine bottle, add 100ml of water to dissolve, add 5ml of hydrochloric acid and starch indicator solution 1ml, immediately use iodine titration solution (0.
01mol/L) titration to the solution from light yellow to light blue to purple red, and the titration results are corrected
with blank tests.

Each 1 ml of iodine titration solution (0.
01 mol/L) is equivalent to 0.
6406 mg of SO2, containing no more than 0.
004%
sulfur dioxide.

Loss on drying Take this product, dry at 105 ° C to constant weight, and the weight loss shall not exceed 6.
0% (General 0831).
Blazing residue Take 2.
0g of this product, check according to law (General Rule 0841), and the residual residue shall not exceed 0.
5%.
Heavy metals: Take the residues left under the incineration residue and inspect them according to law (General Rule 0821 Second Law), and the heavy metals shall not exceed 5
parts per million.

Arsenic salt Take 2.
0g of this product, add 21ml of water, boil, put it cold, add 5ml of hydrochloric acid, check according to law (General 0822 First Law), should comply with the provisions (0.
0001%)
.

DE value Take 0.
5g of anhydrous glucose control, weigh it precisely, place it in a 250ml measuring flask, add water to dissolve and dilute to the scale, shake well, as a glucose control solution
.

When pre-titring, take 10ml of basic copper tartrate test solution with precision, place it in a Erlenmeyer flask, add 20ml of water, add 3 glass beads, add 24ml of glucose control solution with a 50ml burette, shake well, place on an electric furnace and heat it to boil, and keep it slightly boiling, add 2 drops of 1% methylene blue solution, continue to titrate with glucose control solution, until the blue just disappears (the entire titration process is completed in 3 minutes); For formal titration, pre-add a control solution 0.
5 ml less than the pre-titrated glucose control solution
.

The operation is the same as pre-titration, and parallel tests are performed
.

Take another appropriate amount of this product (attached table), precision weighing, placed in a 250ml measuring bottle, heated water to dissolve, cool, diluted with water to the scale, shake well, as a test solution
.

When pre-titring, take 10ml of basic copper tartrate test solution with precision, place it in a Erlenmeyer flask, add 20ml of water, add 3 glass beads, add a certain amount of test solution with a 50ml burette, and operate
according to the same method as the glucose control solution.

When formally titring, pre-add 0.
5ml of the test solution less than pre-titration, operate the same as pre-titration, and do parallel tests
.

Calculate the amount of glucose equivalent to this product as follows; According to the calculation of dried products, the glucose equivalent value (DE value) must not exceed 20
.

Microbial limit Take this product, check according to law (General Rule 1105 and General Rule 1106), the total number of aerobic bacteria per 1g of test product shall not exceed 103cfu, the total number of molds and yeasts shall not exceed 102cfu, and Escherichia coli
shall not be detected.

【Category】Pharmaceutical excipients, coating materials; Diluents, binders, thickeners, etc
.

【Storage】Sealed and stored
in a dry place.