微晶纤维素标准-USP38.docVIP

Microcrystalline Cellulose Cellulose?????[9004-34-6]. DEFINITION Microcrystalline Cellulose is purified, partially depolymerized cellulose prepared by treating alpha cellulose, obtained as a pulp from fibrous plant material, with mineral acids. IDENTIFICATION ???A. Procedure Iodinated zinc chloride solution:??Dissolve 20 g of zinc chloride and 6.5 g of potassium iodide in 10.5 mL of water. Add 0.5 g of iodine, and shake for 15 min. Sample:??10 mg Analysis:??Place the?Sample?on a watch glass, and disperse in 2 mL of?Iodinated zinc chloride solution. Acceptance criteria:??The substance takes on a violet-blue color. Change to read: ???B. Procedure Sample:??1.3 g of Microcrystalline Cellulose, accurately weighed to 0.1 mg Analysis:??Transfer the?Sample?to a 125-mL conical flask. Add 25.0 mL of water and 25.0 mL of 1.0 M cupriethylenediamine hydroxide solution. Immediately purge the solution with nitrogen, insert the stopper, and shake on a wrist-action shaker, or other suitable mechanical shaker, until completely dissolved. Transfer an appropriate volume of the?Sample solution?to a calibrated number 150 Cannon-Fenske, or equivalent, viscometer. Allow the solution to equilibrate at 25 ± 0.1?for NLT 5 min. Time the flow between the two marks on the viscometer, and record the flow time, t1, in s. Calculate the kinematic viscosity, (KV)1, of the Microcrystalline Cellulose taken: Result = t1?× k1 t1 = = flow time (s) k1 = = viscometer constant (see??Viscosity—Capillary Methods?911?(CN 1-May-2015)?) Obtain the flow time, t2, for 0.5 M cupriethylenediamine hydroxide solutions using a number 100 Cannon-Fenske, or equivalent, viscometer. Calculate the kinematic viscosity, (KV)2, of the solvent: Result = t2?× k2 t2 = = flow time for 0.5 M cupriethylenediamine hydroxide solutions (s) k2 = = viscometer constant Determine the relative viscosity,?rel, of the Microcrystalline Cellulose specimen taken: Result = (KV)1/(KV)2 (KV)1 = = kinematic viscosity of the Microcrystalline Cell