Pharmaceutical grade arginine for injection pharmacopoeia registration

This product isL-2-amino-5-Guanylvaleric acid. Calculated by dry product, includingC6H14N4O2no less than99%.

【 Appearance 】 This product is a white crystalline or crystalline powder, almost odorless, with a special odor.

This product is soluble in water and almost insoluble in ethanol; Easy to dissolve in dilute hydrochloric acid.

specific rotation Take this product, weigh it precisely, and add6mol/LDissolve hydrochloric acid solution and dilute it quantitatively to make each1mlModerate content80mgThe solution is determined according to the law(General rule0621)The specific rotation is+26.9° to+27.9°.

【 Identification 】(1)Take an appropriate amount of this product and an appropriate amount of arginine reference substance, and add them separately0.1mol/LDissolve and dilute hydrochloric acid solution to make each1mlModerate content10mgThe solution is used as the test solution and the control solution. According to the methods under other amino acid categories, the position and color of the main spots on the test solution should be the same as those on the control solution.

　　(2)The infrared absorption spectrum of this product should match the reference spectrum(spectral collection1075picture)agreement.

【 Check 】 Alkalinity Take this product2.5gAdd water25mlAfter dissolution, inspect according to law(General rule0631)，pHThe value should be10.5～12.0.

Transmittance of solution Take this product1.0gAdd water10mlAfter dissolution, irradiate with ultraviolet light-Visible spectrophotometry(General rule0401), in430nmThe transmittance measured at the wavelength shall not be lower than98%.

chloride Take this product0.30gInspect in accordance with the law(General rule0801), compared to standard sodium chloride solution6.0mlThe comparison of the prepared control solution should not be thicker(0.02%).

sulfate Take this product1.0gInspect in accordance with the law(General rule0802), compared to standard potassium sulfate solution2.0mlThe comparison of the prepared control solution should not be thicker(0.02%).

ammonium salt Take this product0.10gInspect in accordance with the law(General rule0808), compared to standard ammonium chloride solution2.0mlThe comparison of the prepared control solution should not be deeper(0.02%).

protein Take this product1gAdd water10mlAfter dissolution, add20%trichloroacetic acid solution5Drip, no sediment should be generated.

Other amino acids Thin layer chromatography(General rule0502)Experiment.

solvent 0.1mol/L盐酸溶液。

test solution Take an appropriate amount of this product, dissolve it in a solvent and dilute it to make each one1mlModerate content10mgThe solution.

Reference solution Accurately measure the test solution1ml, set up250mlDilute to the mark with solvent in a volumetric flask and shake well.

System suitability solution Take appropriate amounts of arginine reference substance and lysine hydrochloride reference substance, place them in the same volumetric flask, dissolve and dilute them with solvent to make each1mlContaining approximately arginine in the middle10mgAnd lysine hydrochloride0.4mgThe solution.

Chromatographic conditions Using silicone gelGThin layer plate with n-propanol-Concentrated ammonia solution(6:3)As an expanding agent.

Measurement method Extract the test solution, control solution, and system suitability solution separately5MlPlace them on the same thin plate and unfold them20cmAfterwards, air dry and then90Dry at around ℃10Minutes, cool down, spray1%A n-propanol solution of indanone, in90Heat to ℃ until spots appear, immediately inspect.

System Applicability Requirements The control solution should show a clear spot, while the system suitability solution should show two separate spots.

limit If the test solution shows impurity spots, they must not exceed1One, its color should not be darker than the main spot of the control solution(0.4%).

Loss on drying Take this product, in105Dry at ℃3Hours, weight loss must not exceed0.5%(General rule0831).

residue on ignition Not allowed to pass0.1%(General rule0841).

iron salt Take this product1.0gInspect in accordance with the law(General rule0807), compared to standard iron solution1.0mlThe comparison of the prepared control solution should not be deeper(0.001%).

heavy metal Take this product1.0gAdd water23mlCombined with acetate buffer solution(pH3.5)2mlAfter dissolution, inspect according to law(General rule0821The First Law)The content of heavy metals shall not exceed 10 parts per million.

arsenic salt Take this product2.0gAdd water23mlAfter dissolution, add hydrochloric acid5mlInspect in accordance with the law(General rule0822The First Law), should comply with regulations(0.0001%).

bacterial endotoxin Take this product and inspect it in accordance with the law(General rule1143), every1gThe amount of endotoxin in arginine should be less than10EU.(For injection use)

【 Content determination 】 Take this product approximately80mgAccurately weigh and add anhydrous formic acid3mlAfter dissolution, add ice and acetic acid50mlAccording to the potentiometric titration method(General rule0701), using perchloric acid titrant(0.1mol/L)Titrate and calibrate the titration results with a blank test. each1mlPerchloric acid titrant(0.1mol/L)equivalent to8.710mgofC6H14N4O2.

Pharmaceutical grade arginine for injection pharmacopoeia registration

Pharmaceutical grade arginine for injection pharmacopoeia registration