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White or off-white crystalline powder; odorless, bitter; melting point 140 ~ 145 ° C; specific rotation should be -43 ° to -47 °
Identification
1) Take 10mg of this product, add 1ml of water to dissolve, add 1 ml of copper sulfate test solution and 1ml of sodium hydroxide test solution, shake it, it will be purple; add 1ml of ether to shake, the ether layer should not color. (2) Take 10mg of this product, add 1ml of water to dissolve, add 1 drop of ferric chloride test solution, which is purple. (3) Identification of the chloride in the aqueous solution of this product (Appendix III). (4) The infrared absorption spectrum of this product should be consistent with the control spectrum (spectrum set 819).
Examination pH
4.5-5.5
Solution clarity and color
Take this product 0. 20g, add water 10. O m l to dissolve, the solution should be clear and colorless
Sulfate
≤0.20%
Loss on drying
≤1.0%
Residue on ignition
≤0.2%
relative substance
Norphenylephrine≤0.10%, Phenylephrine related compound C≤0.1%,Phenylephrine related compound D≤0.10%,Phenylephrine related compound E≤0.1%,Any individual unspecified impurity≤0.10%,Total impurities≤0.2%