2 English reference sodium alginate [2 1 century bilingual dictionary of science and technology]
3 Pharmacopoeia standard of sodium alginate 3. 1 Chinese name 3. 1. 1 sodium alginate
3. 1.2 Chinese phonetic alphabet sodium alginate
3. 1.3 English name Na A 1ginate
3.2 CAS number [9005383]
3.3 Source and Content This product is extracted and refined from brown algae with dilute alkali, and its main component is sodium alginate.
3.4 Properties This product is white to light brown powder; Almost odorless and tasteless.
This product swells into colloidal solution in water and is insoluble in ethanol.
3.5 Identification (1) Take 0.2g of this product, add 20ml of water, and shake it from time to time until it is evenly dispersed. Take 5ml of solution and add 1ml of 5% calcium chloride solution, which will produce a lot of colloidal precipitation.
(2) Take 5ml of test solution (1) and add 1ml dilute sulfuric acid to generate a large number of colloidal precipitates.
(3) Take about 10mg of this product, add 5ml of water, add1%,3-dihydroxynaphthalene ethanol solution 1ml and 5ml of hydrochloric acid, shake well, boil for 3min, cool, add 5ml of water and 15ml of isopropyl ether, and shake well. At the same time, do blank test. The upper solution should be dark purple.
(4) Take the residue from residue on ignition, add 5ml of water to dissolve it, and show the sodium salt identification reaction (Appendix III of Pharmacopoeia Part II, 20 10 edition).
3.6 Check 3.6. 1 chloride Take 2.5g of this product, weigh it accurately, put it in a 100ml volumetric flask, add 50ml of dilute nitric acid, shake it evenly 1 hour, dilute it to scale with dilute nitric acid, shake it evenly and filter it; Accurately measure 50ml of continuous filtrate, accurately add 10ml silver nitrate titration solution (0. 1mol/L), 5ml toluene and 2ml ammonium ferric sulfate indicator solution, titrate with ammonium thiocyanate titration solution (0. 1mol/L), and shake violently when dropping to the end. Every 1ml silver nitrate titration solution (0. 1mol/L) is equivalent to 3.545mg Cl. Chloride content shall not exceed 65438 0.0%.
3.6.2 loss on drying takes 0.5g of this product and dries it at 105℃ for 4 hours. The weight loss shall not exceed 15.0% (Appendix VIII L of Pharmacopoeia II 20 10).
3.6.3 Take 0.5g of this product from residue on ignition and check it according to law (Appendix VIII N of Pharmacopoeia II, 20 10 Edition). Calculated by dry product, the residue should be 30.0% ~ 36.0%.
3.6.4 Take the residue under heavy metal residue on ignition, check it according to law (the second method in Appendix VIII H of Pharmacopoeia 20 10, and filter it if necessary), and the content of heavy metal shall not exceed 40 parts per million.
3.6.5 Take 1.0g of arsenic salt, add 1.0g of calcium hydroxide, mix well, add water for wetting, dry, first heat with low fire to make the reaction complete, then gradually increase the fire to make it burn and carbonize, then ignite at 500 ~ 600℃ to make it completely ashed, cool, and add 8ml of hydrochloric acid and 23ml of water to make it completely carbonized.
3.6.6 Take this product for microbial limit and check it according to law (Appendix J, Pharmacopoeia II, 20 10 version). The number of bacteria, molds and yeasts in each 1g sample shall not exceed 1000, and Escherichia coli shall not be detected; Salmonella should not be detected in every 10g sample.
Class 3.7 pharmaceutical excipients, suspending agents and release blockers, etc.
3.8 Storage, sealing and protection.
Version 3.9