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Pharmaceutical grade sodium hydroxide 500 grams 25kg in the preparation of the role [check] alkalinity Take this product, add water to dissolve to make a solution containing 0.
1mg per 1ml, determined according to law (General 0631), the pH value shall not be less than 11.
0
.
The clarity and color of the solution Take 1.
0g of this product, add 20ml of water to dissolve, check according to law (General 0901 and General 0902), the solution should be clear and colorless
.
Chloride Take 0.
50g of this product, check according to law (General 0801), and compare with the control solution made of 2.
5ml of standard sodium chloride solution, it shall not be more concentrated (0.
005%)
.
Sulfate Take 1.
0g of this product, check according to law (General 0802), and compare with the control solution made of standard potassium sulfate solution of 1.
5ml
.
Potassium salt Take 0.
25g of this product, add 5ml of water to dissolve, add acetic acid to make it acidic, cool in an ice bath, and then add a few drops of cobalt sodium nitrite test solution, which must not produce turbidity
.
Aluminum salt and iron salt Take 5.
0g of this product, add dilute hydrochloric acid 50ml after dissolvation, boil, put cold, add ammonia test solution to make it alkaline, filtered, filter residue washed with water 500ml, and blazed to constant weight, the residual residue shall not exceed 5mg
.
Iron salt Take 1.
0g of this product, add water 10ml and hydrochloric acid 2.
5ml dissolved, add water to dissolve into 25ml, check according to law (General 0807), and compare with the control solution made of standard iron solution 1.
0ml, not more concentrated (0.
001%)
.
Heavy metals Take 1.
0g of this product, add 5ml of water and dilute hydrochloric acid 11ml after dissolvation, boil, cool, add 1 drop of phenolphthalein indicator solution and ammonia test solution to an appropriate amount until the solution appears reddish, add acetate buffer (pH 3.
5) 2ml and water to make an appropriate amount of 25ml, according to the law to check (General 0821 first method), containing heavy metals shall not exceed 20
parts per million.
【Content determination】Take 1.
5g of this product, weigh it precisely, add a new boiling and put cold water 40ml to dissolve, cool to room temperature, add 3 drops of phenolphthalein indicator solution, titrate with sulfuric acid titration solution (0.
5mol/L) until red disappears, record the volume of sulfuric acid titration solution, add 2 drops of methyl orange indicator solution, and continue to add sulfuric acid titration solution to show continuous orange-red
.
According to the volume of sulfuric acid titration solution consumed, the total base amount in the test supply amount (calculated as NaOH calculation) is calculated, and the content
of Na2CO3 in the test amount is calculated according to the volume of sulfuric acid titration solution consumed after the addition of methyl orange indicator solution.
Each 1 ml of sulfate titration solution (0.
5 mol/L) is equivalent to 40.
00 mg of NaOH or 106.
0 mg of Na2CO3
.
【Category】Pharmaceutical excipients, pH adjusters
.
【Storage】Sealed and preserved
.
Note: The fractured section of this product shows crystallinity; Strong moisture induction, easy to absorb carbon dioxide
in the air.