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美國USP35文檔求助，道客巴巴上的，有鏈接，誰幫忙下載下
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http://www.doc88.com/p-641608680989.html [ Last edited by shaolei1986 on 2012-9-8 at 09:19 ] |
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shaolei1986: 金幣+4 2012-09-08 11:02:12
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BRIEFING Powdered Andrographis. A new USP Dietary Supplement monograph is proposed— See briefing under Andrographis published elsewhere in this issue of PF. (DSB: M. Sharaf.) RTS—C66624 Add the following: Powdered Andrographis DEFINITION Powdered Andrographis is Andrographis reduced to a fine or very fine powder. IDENTIFICATION • A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST 201 Standard solution 1: Use Standard solution A, prepared as directed in the test for Content of Diterpene Lactones. Standard solution 2: Sonicate an amount of USP Powdered Andrographis Extract RS, equivalent to about 15 mg of diterpene lactones, for 10–15 min in 25 mL of methanol, centrifuge, and use the supernatant. Sample solution: Use Sample stock solution, prepared as directed in the test for Content of Diterpene Lactones. Adsorbent: Chromatographic silica gel mixture with an average particle size of 10–15 µm (TLC plates) Application volume: 10 µL, as 5–10 mm bands Developing solvent system: Chloroform, acetone, and toluene (2:2:1) Spray reagent: A mixture of 1% vanillin in alcohol and 10% sulfuric acid in alcohol (1:1) Analysis Samples: Standard solution 1, Standard solution 2, and Sample solution Use a saturated chamber. Develop the chromatograms until the solvent front has moved about 90% of the length of the plate. Remove the plate from the chamber, dry, spray with the Spray reagent, heat for 5–10 min at 100 , and examine under visible light. Acceptance criteria: The Sample solution exhibits three main grayish blue zones with RF values of approximately 0.4, 0.6, and 0.8 that correspond in position and color to the main zones of Standard solution 2. Standard solution 1 exhibits a grayish blue zone due to andrographolide at an RF of about 0.4. The Sample solution exhibits a zone similar in color and RF value to that due to andrographolide in Standard solution 1. • B. The retention time of the main peak of the Sample solution obtained in the test for Content of Diterpene Lactones corresponds to that of andrographolide in Standard solution A. Identify other diterpene lactone peaks in the Sample solution by comparison with Standard solution B and the reference chromatogram provided with the lot of USP Powdered Andrographis Extract RS. The Sample solution shows additional peaks corresponding to neoandrographolide, 14-deoxy-11,12- didehydroandrographolide, and andrograpanin. COMPOSITION • CONTENT OF DITERPENE LACTONES Solution A: Dissolve 0.14 g of potassium dihydrogen phosphate in 900 mL of water, add 0.5 mL of phosphoric acid, dilute with water to 1000 mL, mix, filter, and degas. Solution B: Use filtered and degassed acetonitrile. Standard solution A: Dissolve a weighed quantity of USP Andrographolide RS in methanol to obtain a solution having a known concentration of about 1.0 mg/mL. Transfer 5.0 mL of this solution to a 10-mL volumetric flask, dilute with acetonitrile to volume, and mix. Standard solution B: Transfer an amount of USP Powdered Andrographis Extract RS, equivalent to about 25 mg of diterpene lactones, to a 50-mL volumetric flask, add 25 mL of methanol, heat gently for 15–20 min, dilute with acetonitrile to volume, and mix. Before injection, pass through a membrane filter having a 0.45-µm or finer porosity, discarding the first 5 mL of the filtrate. Sample stock solution: Transfer about 2.0 g of Powdered Andrographis to a 250-mL flask fitted with a reflux condenser. Add 50 mL of methanol, reflux on a water bath for 15 min, cool to room temperature, and decant the supernatant. Repeat until the last extract is colorless. Combine the extracts, filter, concentrate under vacuum, and adjust the volume to 50.0 mL using methanol. Transfer 25.0 mL of this solution to a 50-mL volumetric flask, dilute with acetonitrile to volume, and mix. Before injection, pass through a membrane filter having a 0.45-µm or finer porosity, discarding the first 5 mL of the filtrate. Sample solution: Transfer 25.0 mL of Sample stock solution to a 50-mL volumetric flask, dilute with acetonitrile to volume, and mix. Before injection, pass through a membrane filter having a 0.45-µm or finer porosity, discarding the first 5 mL of the filtrate. Mobile phase: See the gradient table below. Time (min) Solution A (%) Solution B (%) 0 95 5 18 55 45 25 20 80 28 20 80 35 55 45 40 95 5 45 95 5 Chromatographic system (See Chromatography 621 , System Suitability.) Mode: LC Detector: UV 223 nm Column: 4.6-mm × 25-cm; 5-µm packing L1 Flow rate: 1.5 mL/min Injection size: 20 µL System suitability Samples: Standard solution A and Standard solution B Suitability requirements [ NOTE— The chromatogram from Standard solution B is similar to the Reference chromatogram provided with the lot of USP Powdered Andrographis Extract RS. ] Column efficiency: NLT 5000 theoretical plates, Standard solution A Tailing factor: NMT 1.5 for the andrographolide peak, Standard solution A Relative standard deviation: NMT 2.0%, determined from the andrographolide peak for replicate injections, Standard solution A Resolution: NLT 5 between neoandrographolide and 14-deoxy-11,12- didehydroandrographolide peaks, Standard solution B Analysis Samples: Standard solution A, Standard solution B, and Sample solution Using the chromatogram of Standard solution A, Standard solution B, and the reference chromatogram provided with the lot of USP Powdered Andrographis Extract RS, identify the retention times of the peaks corresponding to the different diterpene lactones. The approximate relative retention times of the different diterpene lactones are provided in the following table: Analyte Relative Retention Time Andrographolide 1.00 Neoandrographolide 1.16 14-Deoxy-11,12-didehydroandrographolide 1.31 Andrograpanin 1.50 Separately calculate the percentages of andrographolide, neoandrographolide, 14- deoxy-11,12-didehydroandrographolide, and andrograpanin in the portion of Powdered Andrographis taken: Result = 10(CS /W)(rU /rS ) × F rU = peak response for each diterpene lactone from the Sample solution rS = peak response for andrographolide from Standard solution A CS = concentration of USP Andrographolide RS in the Standard solution A (mg/mL) W = weight of Powdered Andrographis taken to prepare the Sample solution (g) F = conversion factor for each analyte (1.00 for andrographolide, 3.90 for neoandrographolide, 1.45 for 14-deoxy-11,12-didehydroandrographolide, and 2.65 for andrograpanin) Acceptance criteria: NLT 1.0%, on the dried basis, of the sum of the percentages of andrographolide, neoandrographolide, 14-deoxy-11,12-didehydroandrographolide, and andrograpanin IMPURITIES Inorganic Impurities • ARTICLES OF BOTANICAL ORIGIN, Acid-Insoluble Ash 561 : NMT 3.0% • HEAVY METALS, Method II 231 : NMT 20 ppm Organic Impurities • PROCEDURE: ARTICLES OF BOTANICAL ORIGIN, General Method for Pesticide Residues Analysis 561 : Meets the requirements SPECIFIC TESTS • BOTANIC CHARACTERISTICS Macroscopic: It is a grayish brown powder. Histology Microscopic examination: It reveals cells of the upper and lower epidermis of the leaves, some cells containing large cystoliths, up to 36 µm in diameter and 180 µm long, with a hilum-shaped scar in the large end; 1–4 celled nonglandular hairs; disk-shaped glandular hairs, 8-celled head and very short stalk; diacytic stomata mostly on the lower epidermis; stem epidermal cells, some cells containing cystoliths, stomata, nonglandular hairs and glandular hairs similar to those of the leaves; thin-walled parenchyma cells; collenchyma cells; acicular phloem fibers; tracheids; vessels, with spiral and scalariform thickening. • LOSS ON DRYING 731 : Dry 1.0 g of finely Powdered Andrographis at 105 for 3 h: it loses NMT 12.0% of its weight. • ARTICLES OF BOTANICAL ORIGIN, Total Ash 561 : NMT 15%, determined on 1.0 g of finely Powdered Andrographis • ARTICLES OF BOTANICAL ORIGIN, Alcohol-Soluble Extractives, Method 2 561 : NLT 8.0% • MICROBIAL ENUMERATION TESTS—NUTRITIONAL AND DIETARY SUPPLEMENTS 2021 : The total aerobic bacterial count does not exceed 105 cfu/g; the total combined moldsand yeasts count does not exceed 103 cfu/g; and the bile-tolerant Gram-negative bacteria does not exceed 103 cfu/g. ABSENCE OF SPECIFIED MICROORGANISMS—NUTRITIONAL AND DIETARY SUPPLEMENTS 2022 : Meets the requirements of the tests for absence of Salmonella species and Escherichia coli ADDITIONAL REQUIREMENTS • PACKAGING AND STORAGE: Preserve in well-closed containers, protected from light andmoisture, and store at room temperature. • LABELING: The label states the Latin binomial and, following the official name, the parts of the plant contained in the article. • USP REFERENCE STANDARDS 11 USP Andrographolide RS USP Powdered Andrographis Extract RS 2S (USP33) |
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