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USP 35Dietary Supplements Glucosamine 1333 Staining reagent for 5 min Then stir the solution gently Ginseng American see American Ginseng for 1 min Remove the membrane and destain in 5 acetic acid until the background clears Acceptance criteria The principal spot of the Sample solution has the same migration as the principal spot of the Standard solution NOTE Document the results by taking a picture within Ginseng Asian see Asian Ginseng 15 min of completion of destaining STRENGTH CONTENT OF GLUCOSAMINE Diluent Transfer 29 L of acetic acid and 5 mL of aceto nitrile to a 100 mL volumetric flask containing 50 mL of water Dilute with water to volume Ginseng Siberian see Eleuthero Borate buffer 0 2 M 76 3 g L of sodium borate in water adjusted with hydrochloric acid TS to a pH of 9 5 Acetate buffer 6 80 g L of sodium acetate trihydrate in water adjusted with dilute acetic acid to a pH of 5 9 Derivatizing reagent In a 14 mL polypropylene culture tube dissolve 50 mg of o phthalaldehyde in 1 25 mL of Glucosamine and Chondroitin Sulfate anhydrous methanol Add 50 L of 3 mercaptopropionic Sodium Tablets acid and 11 2 mL of Borate buffer and mix gently Allow to stand in the dark for 30 min before use NOTE Rea DEFINITIONgent strength is maintained by adding 10 L of 3 mer Glucosamine and Chondroitin Sulfate Sodium Tablets arecaptopropionic acid every 2 days Storage should be in prepared from either Glucosamine Hydrochloride Gluco the dark at room temperature and can be used for NMT samine Sulfate Sodium Chloride Glucosamine Sulfate Po 2 weeks tassium Chloride or a mixture of any of them withMobile phase Methanol and Acetate buffer 1 9 Chondroitin Sulfate Sodium Tablets contain NLT 90 0 Standard solution 1 0 mg mL of USP Glucosamine Hy and NMT 120 0 of the labeled amounts of chondroitindrochloride RS in water Allow to stand at room temper sulfate sodium and glucosamine C6H13NO5 ature for 1 h NOTE Chondroitin Sulfate Sodium is extremely hygro Sample solution Transfer an equivalent to 25 mg of scopic once dried Avoid exposure to atmosphere andglucosamine from finely powdered Tablets NLT 20 to weigh promptly a 25 mL volumetric flask Dilute with Diluent to volume Mix on a vortex mixer to suspend the powder in solu IDENTIFICATION tion Sonicate in a 65 water bath for 20 min Remove A The retention time of the major peaks of the Sample from the bath stir for 5 min with the aid of a magnetic solution correspond to those of the Standard solution as stirrer and centrifuge obtained in the test for Content of Glucosamine Chromatographic system B ELECTROPHORESIS 726 See Chromatography 621 System Suitability Barium acetate buffer Dissolve 25 24 g of barium ace Mode LC tate in 900 mL of water Adjust with acetic acid to a pH Detector UV 340 nm of 5 0 and dilute with water to 1000 mL Column 3 0 mm 5 cm packing L1 Staining reagent 0 1 w v toluidine blue in 0 1 M Flow rate 1 mL min acetic acid Injection size 10 L Standard solution Use the Standard solution of middle System suitability concentration from the test for Content of Chondroitin Samples Five individual aliquots of the Standard solu Sulfate Sodium tion derivatized as directed in the Analysis Each deriva Sample solution Prepare as directed in the test for Con tized aliquot is injected only once tent of Chondroitin Sulfate Sodium NOTE The relative retention times for the anomer Analysis Fill the chambers of an electrophoresis appara and the anomer are 1 0 and 1 8 respectively The tus suitable for separations on cellulose acetate mem retention time for the anomer is NLT 4 min branes1 a small submarine gel chamber or one dedi Suitability requirements cated to membrane media with Barium acetate buffer Relative standard deviation NMT 2 0 from five Soak a cellulose acetate membrane 5 6 cm 12 14 cm replicate injections in Barium acetate buffer for 10 min or until evenly wet Analysis ted then blot dry between two sheets of absorbent pa Samples Standard solution and Sample solution per Using an applicator2 suitable for electrophoresis ap Transfer 100 L of the Derivatizing reagent and 100 L of ply equal volumes 0 5 L of the Sample solution and the Standard solution or Sample solution to a vial con Standard solution to the brighter side of the membrane taining 400 L of Borate buffer Allow the derivatization held in position in an appropriate applicator stand or on to proceed for 1 min Inject the derivatized solutions a separating bridge in the chamber Ensure that both immediately after the derivatization reaction ends of the membrane are dipped at least 0 5 1 0 cm Calculate the percentage of the labeled amount of glu deep into the buffer chambers Apply a constant 60 V 6 cosamine C6H13NO5 in the portion of Tablets taken mA at the start for 2 h NOTE Perform the application of solutions and voltage within 5 min because further Result rU rS CS CU Mr1 Mr2 100 drying of the blotted paper reduces sensitivity Place the membrane in a plastic staining tray and withrU peak response of the anomer from the the application side down float or gently immerse inderivatized Sample solution rS peak response of the anomer from the 1Suitable cellulose acetate membranes for electrophoresis are available from derivatized Standard solution Malta Chemetron SRL Milano Italy Fluka Chemical Corp Milwaukee WI and DiaSys Corp Waterbury CTCS concentration of USP Glucosamine Hydrochloride RS in the Standard solution 2Suitable applicators are available from DiaSys Corp Waterbury CT mg mL and Helena Laboratories Beaumont TX Official from May 1 2012 Copyright c 2011 The United States Pharmacopeial Convention All rights reserved Accessed from 128 83 63 20 by nEwp0rt1 on Wed Nov 30 23 38 15 EST 2011 1334 Glucosamine Dietary SupplementsUSP 35 CU nominal concentration of glucosamine in theCalculate the percentage of the labeled amount of Sample solution mg mL glucosamine C6H13NO5 dissolved Mr1 molecular weight of glucosamine 179 17 Result rU rS CS V L Mr1 Mr2 100 Mr2 molecular weight of glucosamine hydrochloride 215 63 rU peak area from the derivatized Sample solution Acceptance criteria 90 0 120 0 rS peak area from the derivatized Standard CONTENT OF CHONDROITIN SULFATE SODIUM solution Diluent Weigh about 297 mg of monobasic potassium CS concentration of USP Glucosamine phosphate 492 mg of dibasic potassium phosphate and Hydrochloride RS in the Standard solution 250 mg of polysorbate 80 and transfer into a 1 L mg mL beaker Dissolve in approximately 900 mL of water and V volume of Medium 900 mL adjust with potassium hydroxide or phosphoric acid to a L label claim of glucosamine mg Tablet pH of 7 0 0 2 Dilute with water to 1 L and mix Mr1 molecular weight of glucosamine 179 17 thoroughly Mr2 molecular weight of glucosamine Standard solutions 1 5 1 0 and 0 5 mg mL of USP hydrochloride 215 63 Chondroitin Sulfate Sodium RS in water Tolerances NLT 75 of the labeled amount of Sample solution Transfer an equivalent to 100 mg of glucosamine C6H13NO5 is dissolved chondroitin sulfate sodium from finely powdered Tablets Determine the percentage of the labeled amount of NLT 20 to 60 mL of water Shake to suspend the chondroitin sulfate sodium dissolved by using the powder in solution Sonicate in a 65 water bath for 20 following method min Remove from the bath and stir or shake for 5 min Standard solutions Titrant and Diluent Proceed as Dilute with water to 100 mL and centrifuge or pass directed in the test for Content of Chondroitin Sulfate through a suitable filter Sodium Titrimetric system Sample solution Use the solution under test See Titrimetry 541 Analysis Proceed as directed in the test for Content of Mode Photometric titration Chondroitin Sulfate Sodium Titrant 1 mg mL of cetylpyridinium chloride in water Calculate the percentage of the labeled amount of Degas before use chondroitin sulfate sodium dissolved Endpoint detection Turbidimetric with a photoelectric probe Result C V L 100 Analysis Samples Standard solutions and Sample solution C determined concentration of chondroitin Transfer 5 0 mL of each Standard solution and the sulfate sodium in the Sample solution Sample solution to separate titration vessels Add 25 mg mL mL of Diluent to each Stir until a steady reading is V volume of Medium 900 mL obtained with a photoelectric probe either at 420 L label claim of chondroitin sulfate sodium 550 or 660 nm Set the instrument to zero in mg Tablet absorbance mode Titrate with Titrant using the Tolerances NLT 75 of the labeled amount of photoelectric probe to determine the endpoint chondroitin sulfate sodium is dissolved turbidimetrically From a linear regression equation WEIGHT VARIATION OF DIETARY SUPPLEMENTS 2091 Meet calculated using the volumes of Titrant consumed the requirements versus concentrations of the Standard solutions determine the concentration of chondroitin sulfate ADDITIONAL REQUIREMENTS sodium in the Sample solution PACKAGING AND STORAGE Preserve in tight light resistant Calculate the percentage of the labeled amount of containers chondroitin sulfate sodium in the portion of Tablets LABELING The label indicates the types of glucosamine taken salts contained in the article and the species source from which the chondroitin was derived Label it to state the Result C CU 100 source s of chondroitin sulfate sodium whether bovine porcine avian or a mixture of any of them The label C determined concentration of chondroitin states on the front panel the content of chondroitin sulfate sodium in the Sample solution sulfate sodium on the dried basis mg mL USP REFERENCE STANDARDS 11 CU nominal concentration of chondroitin sulfate USP Chondroitin Sulfate Sodium RS sodium in the
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