The effect of pharmaceutical grade tromethamine 1kg as a regulator in preparations

1kg of pharmaceutical grade tromethamine is used as a regulator in preparations.
Relevant substances take 0.
20g of this product, put it in a 10ml measuring bottle, add 1ml of water to dissolve, dilute to the mark with methanol, shake well, and use it as the test solution (1) ; Precisely measure 1ml, put it in a 10ml measuring bottle, add methanol to dilute to the mark, shake well, and use it as the test solution (2); take another 20mg of tromethamine reference substance, put it in a 10ml measuring bottle, add methanol to dissolve and Dilute to the mark, shake well, and use it as the reference solution; accurately measure 1ml of the test solution (1), put it in a 100ml measuring bottle, dilute it to the mark with methanol, and shake well, as the control solution
.

According to the thin-layer chromatography (general rule 0502) test, draw 10 μl of each of the above four solutions, and place them on the same silica gel G thin-layer plate (such as a MERCK thin-layer plate or a thin-layer plate with equivalent performance) pre-developed in methanol, respectively.
Ammonia water-isopropanol (1:9) is used as the developing agent.
After development, after drying at 105 °C, spray with potassium permanganate color developing solution (take 0.
5 g of potassium permanganate, add 10 g/L sodium carbonate solution 100 ml Dissolve) to develop color, and check after standing for about 10 minutes
.

If the test solution (1) shows impurity spots, its color should not be darker than the main spots shown in the control solution
.

Loss on drying Take this product and dry it under reduced pressure at 80°C to constant weight, and the weight loss should not exceed 0.
6% (General Rule 0831)
.

Take 1.
0g of this product for the residue on ignition and inspect it according to the law (General Rule 0841), and the remaining residue should not exceed 0.
1%
.

Take 1.
0g of this product for iron salt, put it in a 10ml measuring bottle, add water to dissolve and dilute to the mark, and check according to the law (general rule 0807).
Compared with the control solution made of 1.
0ml of standard iron solution, it should not be deeper (0.
001%)
.

　　Take 1.
0g of this product for nickel salt, add 10ml of water to dissolve, add 1ml of ammonia test solution and 2ml of diacetyl oxime test solution, leave it for 10 minutes, if color develops, mix with standard nickel solution (accurately weigh 0.
6730g of nickel ammonium sulfate, put In a 1000ml measuring bottle, add an appropriate amount of water to dissolve and dilute to the mark, shake well, accurately measure 10ml, put it in a 100ml measuring bottle, add water to dilute to the mark, shake well) 1.
5ml of the control solution prepared in the same way, no deeper (0.
0015 %)
.

　　Heavy metals and residues left under residue on ignition shall be inspected in accordance with the law (the second method of General Rule 0821), and the heavy metals shall not exceed 10 parts per million
.

　　Bacterial endotoxin (for injection) Take this product and check it according to the law (General Rule 1143).
The amount of endotoxin contained in each 1mg tromethamine should be less than 0.
03EU
.

　　[Determination of content] Take about 0.
25g of this product, accurately weigh it, add 80ml of water to dissolve it, add 2 to 3 drops of methyl red indicator solution, and titrate with hydrochloric acid titration solution (0.
1mol/L)
.

Each 1ml of hydrochloric acid titration solution (0.
1mol/L) is equivalent to 12.
11mg of C4H11NO3
.

　　【Category】Pharmaceutical excipients, acid-base balance regulator
.

　　[Storage] shading, sealed preservation
.