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Alarelin Acetate is a white or almost white powder; odorless, hygroscopic This product is dissolved in methanol, slightly soluble in 1% acetic acid solution dissolved specific rotation of this product, accurately weighed, add 1% acetic acid solution, dissolved and diluted quantitatively per 1ml solution containing 5mg, determined by law (Appendix Ⅵ E), by water, no matter acetate calculated specific rotation of -46 ° to -56 °. Absorption coefficient of this product, accurately weighed, dissolved in water and diluted quantitatively containing 0.1mg per 1ml of the solution, according to the UV - visible spectrophotometry (Appendix Ⅳ A), the absorbance was measured at a wavelength of 279nm by water, No acetic acid was calculated, the absorption coefficient (E 1% / 1cm) of 52-57.
Clarity and color of solution of this product 20mg, 2ml dissolved in water, the solution should be clear and colorless; such as color, with yellow on the 2nd standard colorimetric solution (Appendix Ⅸ A), not deeper. Take some acetic acid, accurately weighed, add diluent [Mobile phase A-mobile phase B (95:5)] dissolved and diluted 1ml each containing about 10mg solution as the test solution; Another ice acetic acid amount, accurately weighed, add Diluent 1ml each containing about 0.60mg solution as the reference solution. High performance liquid chromatography Governance (Appendix Ⅴ D) determination, with octadecylsilane bonded silica as a filler, phosphoric acid (phosphate take 0.7ml, add water 1000ml, with sodium hydroxide to adjust pH to 3.0) as mobile phase A, methanol as mobile phase B, gradient elution, detection wavelength was 210nm. Number of theoretical plates calculated peak acetate, not less than 2000. Gradient elution procedure is as follows: Time (min) Mobile phase A (%) mobile phase B (%) 0 95 5 5 50 50 20 50 50 25 95 5 precise amount of the reference solution and the test solution 20μl, were injected liquid chromatograph, record the chromatograms, the external standard method with peak area calculation. Acetic acid containing not more than 7.5%. Amino acid ratio of this product, plus 6mol / L hydrochloric acid solution at 110 ℃ after 24 hours hydrolysis with a suitable amino acid analysis ceremony measured by HPLC, the test with each amino acid alanine molar ratio should meet the following requirements : 0.7 to 1.0 of serine, glutamic acid is 0.9 to 1.1, proline 0.8 to 1.0, 0.9 to 1.1 leucine, tyrosine 0.9 to 1.1, 0.9 to 1.1 histidine, arginine 0.9 to 1.1. For substances of this product, add water containing 0.5mg per 1ml of solution as the test solution; precise amount of 1ml, 100ml flask, diluted with water to the mark, shake, as the control solution. According to the determination under chromatographic conditions, take control solution 20μl into the liquid chromatograph, adjust the sensitivity, the principal component chromatographic peak height of about 50 per cent of full scale; precise amount of the reference solution and the test solution 20μl , were injected into the liquid chromatograph, record the chromatograms to the main component peak retention time of 2 times, the test solution chromatogram, except the solvent peak, a single impurity peak area no larger than the control solution peak area of 2 times. The impurity peak area and peak area shall not be greater than the control solution 5 times (the main component of any less than the control solution peak area 0.05 times the peak to be negligible). Water to remove the goods, according to the determination (Appendix Ⅷ M first method A). Water containing not more than 7.0%.
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