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    48 views4 pages

    Baclofen Tablets USP

    Uploaded by

    Maria

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
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    ( usr ne Baclofen ny ot cutuCINOs 2c, 4-amino-3-(4-chloropheny/).; burynomethyyp-chlorohydrocinnamicacid_(1134-47.0), adofen contains NLT 98.0% and NMT 102.0% of baclofen {Cati,CINO,), calculated on the anhydrous bass, IDENTIFICATION VA. INFRARED ABSORPTION (197M) UBL The retention time of the Sample solution corresponds fo that of the Standard solution, as obtained in the Assay, ASSAY ‘© PROCEDURE : ‘Solution A: Dissolve 1.38 g of potassium dihydrogen ate and 1.74 g of sodium-1-pentanesulfonate in 1 Lof water. Adjust with dilute phosphoric acid to. pH of 3.0. Solution B: Acetonitrile and methanol (1:1) Diluent: Solution A and Solution B (65:35) Mobile phase: See Table 1. Table 1 Time Solution A Solution 8 (rnin) 9), oo ° a 35 5 a 35 8 45 35 25 5 35 7 gi 35 30 6 35 Standard solution: 0.2 mg/ml of USP Baclofen RS in Diluent Sample solution: 0.2 mg/mL of Baclofen in Diluent Cromatograpiic Bhar 5 ‘Suitability.) omatography (621), System Suitability. Mode: LC ees Detector: UV 225 nm Column: 4.6-mm x 25.0-cm; 5-um packing L1 Column temperature: 35° Flow rate: 0.8 mL/min Injection volume: 10 yL System suitability ‘Sample: Standard solution Suitability requirements Tailing factor: NMT 1.5 Relative standard deviation: NMT 1.0% Analysis. Samples: Standard solution and Sample solution Calculate the percentage of baclofen (CoH,2CINO,) in the portion of the Baclofen taken: Result = (r y/r.) x (CofC u) x 100 ak response from the Sample solution peak response from the Standard solution Cs = concentration of USP Baclofen RS in the Standard solution (mg/mL) Official Monographs / Baclofen 465 Cy = concentration of Baclofen in the Samy solution (mg/mL) mo ‘Acceptance criteria: 98.0%-102.0% on the anhydrous IMPURITIES * RESIDUE ON IGNITION (281): NMT 0.3% * ORGANIC IMPURITIES Solution A, Solution B, Diluent, Mobile phase, and Chromatographic system: Proceed as directed inthe say. Standard solution: 0.0015 mg/mL of USP Baclofen RS and 0.003 mg/mL of USP Baclofen Related Compound A RS in Diluent Sample soluti System suitability ‘Sample: Standard solution [Note—See Table 2 for relative retention times.] Suitablity requirements Talling fac 0.3 mg/ml of Baclofen in Diluent \ctor: NMT 1.5 for baclofen Relative standard deviation: NMT 5.0% for both ;clofen and baclofen related compound A Analysi ‘Samples: Standard solution and Sample solution ‘Calculate the percentage of baclofen related compound ‘Ain the portion of the Baclofen taken: Result = (ry/r) x (CC 4) x 100 peak response of baclofen related compound A from the Sample solution rs = peak response of baclofen related ‘compound A from the Standard solution Cs = concentration of USP Baclofen Related ‘Compound A RS in the Standard solution (mg/ml) Cy = concentration of Baclofen in the Sample solution (mg/mL) ry Calculate the percentage of any unspecified impurity in the portion of the Baclofen taken: Result = (ru/r) x (CJC) x 100 Ty = peak response of any unspecified impurity from the Sample solution 5 = peak response of baclofen from the Standard solution Cs =concentration of USP Baclofen RS in the Standard solution (mg/mL) Cy =concentration of Baclofen in the Sample solution (mg/mL) Acceptance criteria: See Table 2. Table 2 ive] Acceptance retention | “Cre Name “Time Nurs) Baclofen 19 = Baclofen elated compound A 23 10 ‘Any indvdal unspected impurity = 010 Total impure = 20 ‘SPECIFIC TESTS ‘* WATER DETERMINATION, Method (921): NMT 3.0% 466 Baclofen / Official Monographs ADDITIONAL REQUIREMENTS * PACKAGING AND STORAGE: Preserve in tight containers. Store at room temperature. ‘* USP REFERENCE STANDARDS (111) USP Baclofen RS USP Baclofen Related Compound A RS 4-(4-Chlorophenyl)-2-pyrrolidinone, CahigCINO 195.65 Baclofen Compounded Oral Suspension DEFINITION Baclofen Compounded Oral Suspension contains NLT 90.0% ‘and NMT 110.0% of the labeled amount of baclofen (Gotts:CINO,). re Baclofen Compounded Oral Suspension 5 mg/mL as lows (see Pharmaceutical Compounding—Nonsterile Preparations (795). Up se from the Sample solution ak response jrom the Standard soliton ae in of USP — RS in the . ion (g/m Stondard sur gin of baclofen in the Co = nore solution (wg/mL) ‘samp! ‘Acceptance criteria: 90.0%-110.0% SPECIFIC TESTS = PH (791): 4.25.2 ais ADDITIONAL REQUIREMED Package egy + PACKAGING ANY a refrigerator containers, tore 3 "95 days after the day oni * evens in stored in a refrigerator Rotlerene state that iis to Be Wel shaken 5 : t j-Use Date. v to state the Beyon aOs “any < USP USP Baclofen RS If using Baclofen Tablets, place the Tablets in a suitable mortar and comminute to a fine powder, or add Baclofen powder. Add 5 ml of the Vehicle to wet the powder, and triturate the powder to form a fine paste. Add the Vehicle in small portions almost to volume, and mix thoroughly after each addition. Transfer, stepwise and quantitatively, the contents of the mortar to a calibrated bottle. Add sufficient Vehicle to bring to final volume, and mix well. ASSAY ‘* PROCEDURE Mobile phase: Acetonitrile and 0.05 M monobasic sodium phosphate (20:80). Adjust with phosphoric acid to a pH of 3.5. Standard solution: 5 g/mL of USP Baclofen RS in water Sample solution: Shake thoroughly by hand each bottle of Oral Suspension. Pipet 0.5 mL of Oral Suspension from each bottle to a 500-mL volumetric flask, dilute with water to volume to obtain a concentration of 5 g/mL, and pass through a 0.22-um polyvinylidene fluoride (PVDF) filter. Chromatographic system (See Chromatography (621), System Suitability.) Mode: LC Detector: UV 220 nm Column: 4.6-mm x 25-cm; 5-1 packing L1 Flow rate: 1 mL/min Injection volume: 15 pL System suitability ‘Sample: Standard solution iene retention time of baclofen is about 5.5 min, Suitability requirements Relative standard deviation: NMT 2.0% for replicate jections Analysis Samples: Standard solution and Sample solution Calculate the percentage of the labeled amount of baclofen (C,gH,CINO,) in the portion of Oral Suspension taken: Result = (ral) x (Cy/C,) x 100 ae. Em Vehicle: a 1:1 mixture of Vehicle for Oral lets ic gol agua on Veh for Baclofen Tablets Sree eae aie | aaa DEFINITION Tablets contain NLT 90.0% and NMT 110.0% of Bacto jcled ammount of baclofen (C,oH1,CINO). IDENTIFICATION : * A. The retention time of the Sample solution corresponds ‘to that of the Standard solution, as obtained in the #B. The UV spectrum of the major peak of the S solution corresponds to that of the Standard solution, as obtained in the Assay. ASSAY * PROCEDURE Solution A: 1.4 g/L of monobasic sodium phosphate and 1.7 g/L of sodium 1-pentanesulfonate in water. Adjust with 1.5 M phosphoric acid TS to a pH of 3.0. Solution B: Acetonitrile and methanol (50:50) Mobile phase: See Table 1. Table 1 Time Solution A Solution | rie) 8) | ° : 6 x 6 8 5 sor] ss Eee zi ss 35 ae 65. 38. a 6s 35 Diluent: Solution A Standard cition A and Solution B (65:35) Diluent lon: 200 \ug/mL of USP Baclofen R59 Sample solution: Nomin: rally 2¢ yaclofen trator Solow. Finely powder NET So tapi 2 Volumetie gion of the powder to an appropriate, Volume, sonst Add Diluent to about 8056 of the fs) means for 3 16 f0F and shake by mecha Centrifuge a per Dilute with Diluent to volume: Supernat Pottion ofthis solution and use the usp 42 hic system cx ttaanhy (621), System Suitability.) ec Mode: ¢ UV 225 nm. For Identification B, use a diode eertgetector in the range of 200-400 nim, chars 46-m » 25-

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