Clarity and color of solution to take this product 1.0g, 10ml ethanol dissolved, the solution should be clear and colorless; such as color, with a yellow or yellow-green on the 1st standard colorimetric solution (Appendix Ⅰ Ⅹ A first law), shall not be deeper.
Acidity solution 2ml under “Clarity and color of solution” item, namely ethanol 2ml, water, 5ml, shake, bromocresol green indicator solution add 2 drops of sodium hydroxide (0.1mol / L) titrated to was blue, consume titrant (0.1mol / L) should be not more than 0.1ml.
Chloride take this product 2.0g, add water 50ml, heated to 80 ℃, let cool, filtered; the filtrate 5.0ml, check (Appendix Ⅷ A) according to the law, with a standard solution of sodium chloride solution 7.0ml compare and contrast made, shall not be thicker (0.035%).
Sulfate take the above filtrate 25ml, according to inspection (Appendix Ⅷ B), potassium sulfate solution 2.4ml comparison with the standard control solution made no thicker (0.024%).
Take some relevant material, plus the mobile phase and dilute containing 1mg per 1ml solution as the test solution; take Butylparaben reference amount, plus the mobile phase and dilute made per 1ml 0.01mg solution as the reference solution; another methylparaben and Ethylparaben amount, plus mobile phase and diluted into a mixed solution containing 0.01mg per 1ml of. High performance liquid chromatography (Appendix Ⅴ D) was measured. Octadecylsilane bonded phase silica as a filler; in 1% acetic acid – methanol (40:60) as the mobile phase; detection wavelength of 254nm. Take a mixed solution 20μl into the liquid chromatograph, record the chromatogram separation, Methylparaben Ethylparaben peak and peak should meet the requirements. Reference solution 20μl, into the liquid chromatograph, adjust the sensitivity, the principal component peak height of about 20% to 25% of full scale; then the precise amount of the test solution and reference solution 20μl, injection liquid chromatograph, record the chromatograms to 2 times the peak retention time. Test solution chromatogram as significant impurity peaks, a single impurity peak area no larger than the reference solution 0.4 times the area of the main peak (0.4%), the impurity peak area no larger than the reference solution and the main peak area of 0.8 times (0.8%).
Drying of this product with silica gel desiccant, vacuum drying to constant weight, weight loss shall not exceed 0.5% (Appendix Ⅷ L).
Residue on ignition to take this product 1.0g, according to the determination (Appendix Ⅷ N), no residue left over 0.1%.
Heavy metals residue left over residue on ignition under, according to the determination (Appendix Ⅷ H Second Law), containing heavy metals must not exceed twenty millionths.
Arsenic take this product 1.0g, calcium hydroxide 1.0g, mix, add water, stir, after drying, the first small fire burning so carbonized, and then at 500 ~ 600 ℃ ignition completely gray, immediately put in an ice bath in let cool, add 5ml of hydrochloric acid and water, 23ml, according to inspection (Appendix Ⅷ J first law), shall meet the requirements (not more than 0.0002%
