Purified water standard, Chinese pharmacopoeia, 2010

This product is pharmaceutical water obtained from drinking water by distillation, ion exchange, reverse osmosis or other suitable methods without any additives.

[properties] this product is a colorless clear liquid;Odorless, tasteless.

[inspection] take 10ml of this product, add 2 drops of methyl red indicating liquid, do not show red;Take another 10ml, add 5 drops of bromothymol blue indicator solution, do not show blue.

Nitrates get a 5 ml tube, of the product in the cooled in water bath, and 10% potassium chloride solution 0.4 ml with diphenylamine 0.1% sulfuric acid solution 0.1 ml, shake well, slowly add sulfuric acid 5 ml, shake well, placing tube in 50 ℃ water bath for 15 minutes, the solution produced by blue and standard of nitrate solution (0.163 g, potassium nitrate and water dissolved and diluted to 100 ml, shake well, precision measuring 1 ml, water to 100 ml, precision measuring 10 ml, water to 100 ml, shake well,(each 1ml is equivalent to 1 g NO3)) 0.3ml, add 4.7ml nitrate-free water, the color after the same treatment should not be darker (0.000.006%).

Nitrite, 10 ml, proper nessler's tube, plus a dilute hydrochloric acid solution of amino benzene sulfonamide (1-100) with 1 ml solution of hydrochloric acid naphthalene ethylenediamine 1 ml (0.1-100), the pink, with standard take sodium nitrite nitrate solution (0.750 g (calculated on dry goods), add water dissolved, diluted to 100 ml, shake well, precision measuring 1 ml, water to 100 ml, shake well, precision measuring 1 ml, again add water dilute into 50 ml, shake well, for a quick (each 1 ml of 1 mu gNO2)) 0.2 ml,Add 9.8ml nitrate-free water, and the color after the same treatment should not be darker (0.000002%).

Take 50ml of ammonia, add 2ml of basic iodide mercury-potassium test solution, and leave it for 15 minutes.For color development, it should not be deeper (0.00003%) than the ammonium chloride solution (31.5mg of ammonium chloride, plus ammonia free water to dissolve and dilute to 1000ml), or the control solution made by adding 48ml ammonia free water and 2ml basic iodide mercury-potassium test solution.

Conductivity (appendix Ⅷ S) should comply with the regulations.

Total organic carbon May 0.50 mg/L (appendix Ⅷ R).

Take 100ml of this product, add 10ml of dilute sulfuric acid, boil it, add 0.10ml of potassium permanganate titrant (0.02mol/L), boil it for another 10 minutes, the pink cannot completely disappear.

The two terms of total organic carbon and easy oxide can be chosen as one of them.

Take 100ml of non-volatile substance, place it in an evaporation dish of constant weight at 105℃, steam it dry on the water bath, and dry it at 105℃ to a constant weight, leaving residue not more than 1mg.

Take 100ml of the heavy metal, add 19ml of water, evaporate to 20ml, cool it, add 2ml of acetate buffer (pH3.5) and water to make 25ml, add 2ml of thioacetamide test solution, shake well, leave it for 2 minutes, compared with standard 1.0ml of lead solution with 19ml of water after the same treatment, should not be darker (0.00001%).

Microbial limit for this product, use the membrane filtration method after processing, in accordance with the inspection (appendix Ⅺ J), the total number of bacteria, mould and yeast each 1 ml shall not be over 100.

Category: solvent and diluent.

Store in close storage.

China pharmacopoeia for water for injection (2010)

This product is purified water obtained from distilled water.

[properties] this product is a colorless clear liquid;Odorless, tasteless.

PH check 】 【 take this 100 ml, add 0.3 ml, saturated KCL solution determination (appendix Ⅵ H) in accordance with the law and the pH value should be 5.0 ~ 7.0.

Take 50ml of ammonia and check it according to the method under purified water, but change it to 1.0ml with ammonium chloride solution for the control, which should meet the requirements (0.00002%).

Nitrate and nitrite, electrical conductivity, total organic carbon, nonvolatile matter and heavy metal should be inspected by the method under purified water.

Bacterial endotoxin in this product, check (appendix Ⅺ E) in accordance with the law, each 1 ml of endotoxin content should be less than 0.25 in the EU.

Microbial limit for this product at least 200 ml, the membrane filtration method after processing, in accordance with the inspection (appendix Ⅺ J), the total number of bacteria, mould and yeast per 100 ml May 10.

[class] solvent.

Store in close storage.

Chinese pharmacopoeia of water for sterilized injection (2010)

This product is prepared by the production process of water for injection.

[properties] this product is a colorless clear liquid;Odorless, tasteless.

PH check 】 【 take this 100 ml, add 0.3 ml, saturated KCL solution determination (appendix Ⅵ H) in accordance with the law and the pH value should be 5.0 ~ 7.0.

Chloride, sulfate and calcium salt were separated into three test tubes, each tube was 50ml, the first tube was added with 5 drops of nitric acid and 1ml of silver nitrate reagent, the second tube was added with 5ml of barium chloride reagent, and the third tube was added with 2ml of ammonium oxalate test solution. Turbidity was not allowed.

Take 25ml of carbon dioxide, place it in a 50ml measuring cylinder with a plug, add 25ml of calcium hydroxide test solution, shake the dense plug, place it, and do not cause turbidity within 1 hour.

Take 100ml of this product, add 10ml of dilute sulfuric acid, boil it, add 0.10ml of potassium permanganate titrant (0.02mol/L), boil it for another 10 minutes, the pink cannot completely disappear.

Nitrate and nitrite, ammonia, electrical conductivity, nonvolatile substances, heavy metals and bacterial endotoxins shall be inspected in accordance with the method under water for injection.

Other should comply with the relevant injection under the provisions of (appendix Ⅰ B)

[category] solvents, rinsing agents.

Specification (1) 1ml (2) 2ml (3) 3ml (4) 5ml (5) 10ml (6) 20ml (7) 50ml (8) 500ml (9) 1000ml (10) 3000ml (for washing)

Store in close storage.