This substance is fructose-1,6-diphospate trisodium salt or fructose-1,6-diphospate trisodium salt octahydrate. The content of C6H11Na3O12P2 in anhydride shall not be less than 95.0%.
[Property] This substance, a white or off-white crystalline powder, has slight odor and slight salty taste; fructose-1,6-diphospate trisodium salt has high hygroscopicity.
This substance is freely soluble in water, and practically insoluble in sulfuric ether, alcohol or dimethylketone.
[Identification]
(1) Take appropriate amount of this substance and Fructose Sodium Diphosphate control sample, respectively add water to dissolve, dilute them to the solutions containing about 50mg solute per 1ml solution, and use them respectively as tested solution and control sample solution. As stated in the thin layer chromatography (Chinese Pharmacopoeia, Edition 2010, Part II, AppendixⅤB), take respectively 10μl of the solutions above, place them on same thin microcrystalline cellulose layer plate (about 0.5mm in thickness), and apply the developing agent n-butyl alcohol- acetic acid glacial- water- dimethylketone- 10% ammonia solution (35: 20: 22.5: 15: 7.5) before flash it off; spray with metaphenylendiamine hvdrochloride ethanol solution (take 0.36g of metaphenylendiamine hvdrochloride, add 10ml of 76% ethanol solution to dissolve), and heat at 105℃ for 30min for color development. The position of the principal spot developed from the tested solution shall be same to that developed from the control sample solution; continue to spray with dimethylketone- 12.5% ammonium molybdate solution- hydrochloric acid- perchloric acid (86: 8: 3: 3), and the position and color of the principal spot developed from the tested solution shall be same to that developed from the control sample solution.
(2) Take about 50mg of the tested sample, place it in a crucible, add 2g of anhydrous sodium carbonate, mix them up, and scorch it to cinefaction; cool it up, add 10ml of water to dissolve; add nitric acid to acidify; filter the solution; add ammonium molybdate test solution in the filtrate, heat it, yellow precipitation appears; add excessive amount of ammonia test solution and the precipitation dissolves.
(3) The infra-red reference spectra of this substance shall be consistent with the control sample spectra given in "Chinese Pharmacopoeia, Edition 2010, Part II, Appendix IV C".
(4) Identification of sodium salt property of this substance's water solution (Chinese Pharmacopoeia, Edition 2010, Part II, Appendix III).
[Determination]
Acidity: Take 1.0g of C6H11Na3O12P2 or 1.3g of C6H11Na3O12P2•8H2O, add 10ml of water for dissolution; and determinate them as stated in "Chinese Pharmacopoeia, Edition 2010, Part II, Appendix VI H"; the pH value shall be 5.5~6.5.
Clarity and color of solution: Take 1.5g of C6H11Na3O12P2 or 2.0g of C6H11Na3O12P2•8H2O, and add 10ml of water for dissolution; the solution shall be clear and colorless. If the solution shows color, compare it with yellow, orange or green-yellow No.2 standard colorimetric solution (Chinese Pharmacopoeia, Edition 2010, Part II, Appendix IX A, Method 1); the color shall not be darker than that of the colorimetric solution.
This substance is fructose-1,6-diphospate trisodium salt or fructose-1,6-diphospate trisodium salt octahydrate. The content of C6H11Na3O12P2 in anhydride shall not be less than 95.0%.
[Property] This substance, a white or off-white crystalline powder, has slight odor and slight salty taste; fructose-1,6-diphospate trisodium salt has high hygroscopicity.
This substance is freely soluble in water, and practically insoluble in sulfuric ether, alcohol or dimethylketone.
[Identification]
(1) Take appropriate amount of this substance and Fructose Sodium Diphosphate control sample, respectively add water to dissolve, dilute them to the solutions containing about 50mg solute per 1ml solution, and use them respectively as tested solution and control sample solution. As stated in the thin layer chromatography (Chinese Pharmacopoeia, Edition 2010, Part II, AppendixⅤB), take respectively 10μl of the solutions above, place them on same thin microcrystalline cellulose layer plate (about 0.5mm in thickness), and apply the developing agent n-butyl alcohol- acetic acid glacial- water- dimethylketone- 10% ammonia solution (35: 20: 22.5: 15: 7.5) before flash it off; spray with metaphenylendiamine hvdrochloride ethanol solution (take 0.36g of metaphenylendiamine hvdrochloride, add 10ml of 76% ethanol solution to dissolve), and heat at 105℃ for 30min for color development. The position of the principal spot developed from the tested solution shall be same to that developed from the control sample solution; continue to spray with dimethylketone- 12.5% ammonium molybdate solution- hydrochloric acid- perchloric acid (86: 8: 3: 3), and the position and color of the principal spot developed from the tested solution shall be same to that developed from the control sample solution.
(2) Take about 50mg of the tested sample, place it in a crucible, add 2g of anhydrous sodium carbonate, mix them up, and scorch it to cinefaction; cool it up, add 10ml of water to dissolve; add nitric acid to acidify; filter the solution; add ammonium molybdate test solution in the filtrate, heat it, yellow precipitation appears; add excessive amount of ammonia test solution and the precipitation dissolves.
(3) The infra-red reference spectra of this substance shall be consistent with the control sample spectra given in "Chinese Pharmacopoeia, Edition 2010, Part II, Appendix IV C".
(4) Identification of sodium salt property of this substance's water solution (Chinese Pharmacopoeia, Edition 2010, Part II, Appendix III).
[Determination]
Acidity: Take 1.0g of C6H11Na3O12P2 or 1.3g of C6H11Na3O12P2•8H2O, add 10ml of water for dissolution; and determinate them as stated in "Chinese Pharmacopoeia, Edition 2010, Part II, Appendix VI H"; the pH value shall be 5.5~6.5.
Clarity and color of solution: Take 1.5g of C6H11Na3O12P2 or 2.0g of C6H11Na3O12P2•8H2O, and add 10ml of water for dissolution; the solution shall be clear and colorless. If the solution shows color, compare it with yellow, orange or green-yellow No.2 standard colorimetric solution (Chinese Pharmacopoeia, Edition 2010, Part II, Appendix IX A, Method 1); the color shall not be darker than that of the colorimetric solution.
