and guarantee the smoothness of purified water inspection.
2. Applicable Scope: The procedure is applicable to inspection of purified water.
3. Responsibilities:QC lab technician shall be responsible for implementation of the procedure,
and lab director shall be responsible for supervising and inspecting the effective
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implementation of the procedure.
4. Contents:
4.1 Inspection basis: Chine Pharmacopoeia 2010 Part 2.
4.2 Source: The product is medicinal water which is obtained in distillation method and ion
exchange method and contains no additive.
4.3 Character: This product is colorless clear liquid; odorless and tasteless.
4.4 Inspection
4.4.1 PH value
4.4.1.1 Instruments and tools: Test tube and dropper.
4.4.1.2 Reagents and test solutions: Methyl red indicator solution, bromthymol blue indicator
solution.
4.4.1.3 Operation method, result and judgment: Take 10ml the product, add two drops of methyl red
indicator solution, and it isn’t red; take another 10ml the product, add five drops of bromthymol blue indicator solution, and it isn’t blue, and then it can be judged that the product is qualified.
4.4.2 Nitrate
4.4.2.1 Instruments and tools: electric-heated thermostatic water bath, measuring cylinder, test tube,
transfer pipette, analytical balance, and volumetric flask.
4.4.2.2 Reagents and test solutions: 10% potassium chloride solution, 0.1% diphenylamine sulfuric
acid solution, and standard nitrate solution.
4.4.2.3 Operation method: Take 5ml this product, put it in the test pipe, and cool it in ice bath, then
add 0.4ml 10% potassium chloride solution and 0.1ml 0.1% diphenylamine sulfuric acid solution, and shake them evenly, then slowly add 5ml sulfuric acid, shake them evenly, and put the test tube in 50℃water bath for 15min, and compare the blue color generated by this solution with the color generated by 0.3ml standard nitrate solution [which is prepared in the method: take 0.163g potassium nitrate, add water to dissolve and dilute it to be 100ml, then shake it evenly, and measure
1ml accurately, and add water to dilute it to be 100ml, and measure 10ml accurately, and add water to dilute it again to be 100ml, shake it evenly, and obtain the standard nitrate solution (1ml is equivalent to 1μgNO3)] added with 4.7ml water
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without nitrate and treated in the same method.
4.4.2.4 Result and judgment: Compare the color of test solution with the color of control solution,
and if it is not deeper (0.000006%), it can be judged qualified.
4.4.3 Nitrite
4.4.3.1 Instruments and tools: Nessler tube, measuring cylinder, transfer pipette, and volumetric悠然自得
flask.
聊斋辛十四娘4.4.3.2 Reagents and solutions: Diluted hydrochloric acid added with aminobenzenesul fonamide,
N-ethylenediamine solution (0.1→100), and standard nitrite solution
里字的笔顺4.4.3.3 Operation method: Take 10ml purified water, put it in the Nessler tube, add 1ml diluted
hydrochloric acid added with aminobenzenesul fonamide (1→100)to 1ml N-ethylenediamine (0.1→100), and compare the pink color generated by it, with the color generated by 0.2ml standard nitrite solution [which is prepared in the method: take 0.750g sodium nitride (calculated on the basis of dry goods), dissolve it with water and dilute it to be 100ml, shake it evenly, then accurately measure 1ml, add water to dilute it to be 100ml, shake it evenly, and accurately measure 1ml again, add water to dilute it to be 50ml, shake it evenly, and obtain the standard nitrite solution (1ml is equivalent to 1μgNO2)] added with卸妆棉怎么用
9.8ml water without nitrite and treated in the same method.
4.4.3.4 Result and judgment: Compare the color of test solution with the color of control solution,
and if it is not deeper (0.000002%), it can be judged qualified.
4.4.4 Ammonia
4.4.4.1 Instruments and tools: Measuring cylinder, test tube, and Nessler tube
4.4.4.2 Reagents and solutions: alkali potassium mercuric iodide test solution, ammonium chloride
solution, and volumetric flask
4.4.4.3 Operation method: Take 50ml purified water, add 2ml alkali potassium mercuric iodide test
solution, and keep it still for 15min; if its color is developed, compare it with the control solution prepared by 1.5ml ammonium chloride solution added with 48ml non-ammonia water and 2ml alkali potassium mercuric iodide test solution.
4.4.4.4 Result and judgment: Compare the color of test solution with the color of control solution,
and if it is not deeper (0.00003%), it can be judged qualified.
4.4.5 Conductivity
4.4.
5.1 Measure the conductivity of purified water according to the conductivity inspection method,
and it shall conform to the conductivity of purified water at corresponding temperature.
4.4.6 Readily oxidizable substance
4.4.6.1 Instruments and tools: Measuring cylinder, electric furnace, and beaker.
4.4.6.2 Reagents and test solutions: Diluted sulfuric acid, and potassium permanganate titrant
(0.02mol/L).
4.4.6.3 Operation method: Take 100ml purified water, add 10ml diluted sulfuric acid, and after
boiling, add 0.10ml potassium permanganate titrant (0.02mol/L), and then boil them for 10min.
4.4.6.4 Result and judgment: If the pink color doesn’t disappear completely, it can be judged
qualified.
4.4.7 Nonvolatile matter
4.4.7.1 Instruments and tools: Evaporating dish, water bath, electric thermostatic drying over, and
measuring cylinder.
4.4.7.2 Operation method: Take 100ml of purified water, put it in 105℃constant-weight
evaporating dish, and evaporate it on water bath, and dry it at 105℃until reaching constant weight.
4.4.7.3 Result and judgment: If the residue is not more than 1mg, it can be judged qualified.
4.4.8 Heavy metal
4.4.8.1 Instruments and tools: Measuring cylinder, Nessler tube, and transfer pipette.
4.4.8.2 Reagents and test solutions: acetate buffer solution (pH3.5), thioacetamide test solution, and
standard lead solution.
4.4.8.3 Operation method: Take 100ml purified water, add 19ml water, evaporate them till 20ml,
keep it cool, and then add 2ml acetate buffer solution (PH3.5) and add an appropriate amount of water to reach 25ml, then add 2ml thioacetamide test solution, shake them evenly, and then place them for 2min, and compare its color with the color of 1.0ml standard lead solution added with 19ml water and treated in the same method.
4.4.8.4 Result and judgment: Compare the color of test solution with the color of control solution,
and if it is not deeper (0.00001%), it can be judged qualified.
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4.4.9 Microbial limit inspection:
4.4.9.1 Take the purified water, and filter it in the membrane filtration method, and the
water-soluble filter membrane with the aperture of filter membrane not greater than 0.45µm and with the diameter of around 50mm shall be adopted. After filtering directly, take out the filter membrane, and put them on the plate of nutrient medium, and culture them for 48h.物业维修
4.4.9.2 Criterion: The total count of bacteria, moulds and yeasts cannot be more than 100 per ml. 4.4.9.3 Precautions: The filter and filter membrane shall be sterilized in appropriate method before
u, and their integrity before and after filtering shall be guaranteed in u
5. Supplementary Provisions:
6. The document is drafted by QC, reviewed by QC director, and approved by Quality
Department head.
