1, pharmaceutical water (process water: water used in the production process of pharmaceuticals, including drinking water, purified water, water for injection) Classification
1) Drinking water (Potable-Water): usually tap water or deep well water supplied by the water supply company, also known as raw water, the quality of which must meet the national standard GB5749-85, "Drinking Water Hygiene Standards". The quality must meet the national standard GB5749-85 "Health Standard for Drinking Water". According to the 2000 Chinese Pharmacopoeia, drinking water can not be used directly as preparation or test water.
2) Purified Water (Purified Water): Raw water by distillation, ion exchange, reverse osmosis or other suitable methods of pharmaceutical water, without any additional agents. Purified water can be used as a solvent for the preparation of ordinary pharmaceutical preparations or test water, shall not be used for the preparation of injections using ion exchange, reverse osmosis, ultrafiltration and other non-thermal treatment of purified water is generally known as deionized water. The use of specially designed distillers with distillation of purified water prepared by the distillation method is generally known as distilled water.
3) Water for Injection (Water for Injection): purified water as raw water, distilled by specially designed distillers, condensation and cooling prepared by membrane filtration and water. Water for Injection can be used as a solvent for the preparation of injections.
4) Sterilization of water for injection (Sterile Water for Injection): water for injection prepared in accordance with the production process of injectable water. Sterile Water for Injection is used as a solvent for sterilized powder or diluent for injection.
2, pharmaceutical water quality standards
1) Drinking water: should be consistent with the People's Republic of China *** and the national standard "Drinking Water Hygiene Standards" (GB5749-00)
2) purified water: should be consistent with the "2000 Chinese Pharmacopoeia," contained in the purified water standards. In the water production process is usually used in the online detection of the size of the resistivity value of purified water to reflect the concentration of various ions in the water. Pharmaceutical industry, the resistivity of purified water is usually ≥ 0.5MΩ.CM/25 ℃, for injections, eye drops container rinse of purified water resistivity should be ≥ 1MΩ.CM/25 ℃.
3) water for injection: should be in line with the 2000 Chinese Pharmacopoeia contained in the standard of water for injection. Purified water in the pharmaceutical and health industry as one of the most widely used raw materials, due to the universality and importance of its application, has been the Chinese Pharmacopoeia contained. As a raw material, according to its preparation process and quality characteristics, after continuous modification and demonstration, since the publication of the Pharmacopoeia, are listed as one of the mandatory nitrate inspection items.
Chemical indicators: in line with the People's Republic of China *** and the National Pharmacopoeia 2010 version of the pharmaceutical purified water requirements
Hygienic inspection: microorganisms 10CFU/100ml
Endotoxin 0.25EU/ml
Conductivity ≤ 2 μS/cm ( Resistivity ≥ 0.5 M Ω * CM)
These products are potable water by distillation This product is a pharmaceutical water made from drinking water by distillation, ion exchange, reverse osmosis or other suitable methods, and does not contain any additives.
1, properties:
This product is a colorless clarified liquid; odorless, tasteless.
2, check the acidity and alkalinity:
Take 10ml of this product, add 2 drops of methyl red indicator solution, it shall not show red color; another 10ml, add 5 drops of bromo musk vanillin blue indicator solution, it shall not show blue color.
3, nitrate:
Take 5ml of this product in a test tube, cooled in a water bath, add 10% potassium chloride solution 0.4ml and 0.1% diphenylamine sulfuric acid solution 0.1ml, shaking well, slowly add drops of sulfuric acid 5ml, shaking well, will be placed in a 50 ℃ water bath for 15 minutes, the blue color produced by the solution and the standard nitrate solution [take 0.163g of potassium nitrate. Add water to dissolve and dilute to 100 ml, shake well, precision measurement of 1 ml, add water to dilute to 100 ml, and then precision measurement of 10 ml, add water to dilute to 100 ml, shake well, that is (every 1 ml is equivalent to 1ugNO3)] 0.3 ml, plus 4.7 ml of water without nitrate, with the same method of treatment of color comparisons, shall not be darker (0.000006%).
4, nitrite:
Take 10ml of this product, placed in a nano tube, p-aminobenzenesulfonamide dilute hydrochloric acid solution (1→100) 1ml with naphthalene ethylenediamine hydrochloric acid solution (0.1→100) 1ml, produce pink color, with standard nitrite solution [take sodium nitrite 0.75g (calculated as dry product), add water to dissolve, dilute to 100ml. Shake well, precision measurement of 1ml, diluted to 100ml with water, shake well, and then precision measurement of 1ml, diluted to 50ml with water, shake well, that is (every 1ml is equivalent to 1ugNO2)] 0.2ml, add 9.8ml of water without nitrite, with the same method of treatment of color comparisons, shall not be darker (0.000002%).
5, ammonia:
Take 50ml of this product, add alkaline potassium mercuric iodide test solution 2ml, leave it for 15 minutes; if the color develops, compare it with ammonium chloride solution (take ammonium ammonium 31.5mg, add appropriate amount of ammonia-free water to make it dissolve and dilute it into 1,000ml) 1.5ml, add 48ml of ammonia-free water with alkaline potassium mercuric iodide test solution made of 2ml, it shall not be darker ( 0.00003%).
6, total organic carbon:
Not more than 0.50mg/L (0.5ppm, 500ppb)
7, easy to oxidize:
Take 100ml of this product, add 10ml of dilute sulfuric acid, boil, add potassium permanganate titrant (0.02mol/L) 0.10ml, then boil for 10 minutes, pink shall not disappear completely.
Note: The above total organic carbon and easy to oxidize two optional one.
8, non-volatile substances:
Take 100ml of this product, put in 105 ℃ constant weight evaporation dish, evaporate on a water bath, and dry at 105 ℃ to a constant weight, the residue shall not be more than 1mg.
9, heavy metals:
Take 100ml of this product, 19ml of water, evaporate to 20ml, cool and add acetate buffer ( pH3.5), and then boil for 10 minutes, the pink color shall not disappear completely. pH3.5) 2ml and water to make 25ml, add 2ml of thioacetamide test solution, shake well, let stand for 2 minutes, and standard lead solution 1.0ml plus water 19ml with the same method of color comparison after treatment, shall not be darker (0.000 01%).
10, conductivity:
(10 ℃, ≦3.6 ??‰/cm), (20 ℃, ≦4.3 ??‰/cm), (25 ℃, ≤5.1 ??‰/cm)
11, microbial limit:
Take the product, using membrane filtration method of treatment, according to the law, inspection (Appendix Ⅺ J), the total number of bacteria, molds and yeast per 1ml Shall not exceed 100. Hospital water purification pure equipment characteristics, purified water storage cycle should not be greater than 24 hours, its tank should be made of stainless steel or verified non-toxic, corrosion-resistant, non-leaching contaminating ions of other materials. Protect its air vent should be installed without shedding fibers of hydrophobic sterilization filter. The inner wall of the tank should be smooth, and the receiver and welds should not have dead ends and trachoma. Purified water indicators Chemical indicators: in line with the People's Republic of China **** and the National Pharmacopoeia 2005 version of the pharmaceutical purified water requirements
Sanitary inspection: microbial 10CFU/100ml
Endotoxin 0.25EU/ml
Conductivity ≤ 2μS/cm (resistivity ≥ 0.5 M Ω * CM) equipment basic technical characteristics (1) system using (1)The system adopts full-automatic control (manual control is also available), and automatic backwashing and regeneration programs can be set when the system is running; (2)The primary reverse osmosis and secondary reverse osmosis are equipped with reflux pipelines, and the reverse osmosis equipment is equipped with chemical cleaning devices and disinfection devices; (3)There is a PH adjusting device between the primary reverse osmosis and the secondary reverse osmosis, so as to ensure that the conductivity of the water produced by the equipment is in line with the requirements of the pharmacopoeia; (4)The secondary reverse osmosis membrane is made of positively charged anti-pollution reverse osmosis membrane, and the conductivity of water produced by the equipment meets the requirements of the Pharmacopoeia. Positively charged anti-pollution reverse osmosis membrane to ensure that the reverse osmosis equipment for long-term stable operation; (5) the first reverse osmosis pipeline using 304 stainless steel, secondary reverse osmosis using 316L stainless steel materials; purified water quality standards:
Resistivity: ≥ 0.5MΩ.CM
Conductivity: ≤ 2μS
Ammonia ≤ 0.3μg / ml
Nitrate ≤0.06μg/ml
Heavy metals ≤0.5μg/ml
Microorganisms 10CFU/100ml
Endotoxin 0.25EU/ml Water for the production of medical I.V., pharmaceutical preparations, biological preparations, etc. Water for genetic engineering and kidney dialysis.