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wells6860木蟲 (正式寫手)
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[求助]
求助USP37標(biāo)準(zhǔn)��！
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| 各位大俠，急求頭孢地尼（Cefdinir）膠囊和口服混懸劑的USP37標(biāo)準(zhǔn)！小弟先謝過了�。�！ |
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wells6860
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6樓2014-08-12 08:20:45
dingjinglvde
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【答案】應(yīng)助回帖
★ ★ ★ ★ ★
感謝參與，應(yīng)助指數(shù) +1
wells6860: 金幣+5, 雖然不是pdf的，但還是十分感謝��！ 2014-08-01 11:54:34
感謝參與，應(yīng)助指數(shù) +1
wells6860: 金幣+5, 雖然不是pdf的，但還是十分感謝��！ 2014-08-01 11:54:34
|
Cefdinir Capsules DEFINITION Cefdinir Capsules contain NLT 90.0% and NMT 110.0% of the labeled amount of cefdinir (C14H13N5O5S2). IDENTIFICATION • A. Ultraviolet Absorption 197U Buffer: Prepare as directed in the Assay. Blank: Use the Buffer. Standard solution: 10 µg/mL of USP Cefdinir RS in Buffer Sample solution: Equivalent to 10 µg/mL of cefdinir from Capsules in Buffer. Filter before use. Cell size: 1 cm Acceptance criteria: Sample solution maxima and minima occur at the same wavelengths as those in the Standard solution. • B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. ASSAY • Procedure Buffer: 10.7 g/L of dibasic sodium phosphate and 3.4 g/L of monobasic potassium phosphate. Adjust with phosphoric acid or sodium hydroxide to a pH of 7.0 ± 0.05 before final dilution. Solution A: 7 g/L citric acid monohydrate. Adjust with phosphoric acid to a pH of 2.0 ± 0.05. Mobile phase: Methanol, tetrahydrofuran, and Solution A (111:28:1000) System suitability solution: 50 µg/mL of USP Cefdinir RS and 175 µg/mL of m-hydroxybenzoic acid in Buffer Standard solution: 50 µg/mL of USP Cefdinir RS in Buffer Sample solution: Equivalent to 50 µg/mL of cefdinir, from Capsule contents (NLT 20) in Buffer Chromatographic system (See Chromatography 621, System Suitability.) Mode: LC Detector: UV 254 nm Column: 3.9-mm × 15-cm; 4-µm packing L1 Flow rate: 1.4 mL/min Injection size: 15 µL System suitability Samples: System suitability solution and Standard solution Suitability requirements Resolution: Greater than 3.0 between cefdinir and m-hydroxybenzoic acid, System suitability solution Tailing factor: NMT 2.0 for cefdinir, System suitability solution Relative standard deviation: NMT 1.0% for cefdinir, Standard solution Analysis Samples: Standard solution and Sample solution Calculate the percentage of the labeled amount of cefdinir (C14H13N5O5S2) in the portion of Capsules taken: Result = (rU/rS) × (CS/CU) × 100 rU = = peak response for cefdinir from the Sample solution rS = = peak response for cefdinir from the Standard solution CS = = concentration of the Standard solution (µg/mL) CU = = nominal concentration of cefdinir in the Sample solution (µg/mL) Acceptance criteria: 90.0%–100.0% PERFORMANCE TESTS • Dissolution 711 Medium: 50 mM phosphate buffer pH 6.8; 900 mL Apparatus 2: 50 rpm Time: 30 min Detector: UV 290 nm Cell length: 0.1-cm flow cell Standard solution: 0.33 mg/mL of USP Cefdinir RS in Medium Sample solution: Pass a portion of the solution under test through a suitable filter of 0.45-µm pore size. Dilute with Medium to a concentration of about 0.33 mg/mL of cefdinir. Blank: Dissolve 1 empty Capsule in 100 mL of Medium, and dilute to 900 mL. Filter if necessary. Analysis: Determine the percentage of the labeled amount of cefdinir (C14H13N5O5S2) dissolved: Result = (AU/AS) × CS × D × (V/L) × 100 AU = = absorbance of the Sample solution AS = = absorbance of the Standard solution CS = = concentration of the Standard solution (mg/mL) D = = dilution factor of the Sample solution (mL/mL) V = = volume of Medium, 900 mL L = = label claim (mg/Capsule) Tolerances: NLT 80% (Q) of the labeled amount of cefdinir (C14H13N5O5S2) is dissolved. • Uniformity of Dosage Units 905: Meet the requirements IMPURITIES Change to read: • Organic Impurities Solution A: 14.2 g/L of anhydrous dibasic sodium phosphate Solution B: 13.6 g/L of monobasic potassium phosphate Solution C: Dilute tetramethylammonium hydroxide (10% aqueous) with water to obtain a 0.1% solution. Adjust with dilute phosphoric acid (1 in 10) to a pH of 5.5 ± 0.1. Solution D: 37.2 mg/mL of edetate disodium Solution E: To 1000 mL of Solution C add 0.4 mL of Solution D. Solution F: Acetonitrile, methanol, Solution C, and Solution D (150: 100: 250: 0.2) Buffer: Combine appropriate amounts of Solution A and Solution B (about 2:1) to obtain a solution with a pH of 7.0 ± 0.1. Mobile phase: See Table 1. Table 1 Time (min) Solution E (%) Solution F (%) 0 95 5 2 95 5 22 75 25 32 50 50 37 50 50 38 95 5 58 95 5 System suitability stock solution 1: 40 µg/mL of USP Cefdinir Related Compound A RS in Solution C System suitability stock solution 2: 40 µg/mL of USP Cefdinir Related Compound B RS in Solution C System suitability solution: Transfer 37.5 mg of USP Cefdinir RS to a 25-mL volumetric flask. Add about 10 mL of Buffer. Add 5.0 mL of each of System suitability stock solution 1 and System suitability stock solution 2, and dilute with Solution C to volume. Standard stock solution: 750 µg/mL of USP Cefdinir RS in Buffer Standard solution: 15 µg/mL of USP Cefdinir RS, from the Standard stock solution in Solution C Sample solution: Transfer an equivalent to 300 mg of cefdinir from Capsule contents (NLT 20) into a 200-mL volumetric flask. Dissolve in 30 mL of Buffer, and dilute with Solution C to volume to obtain a solution having a nominal concentration of about 1.5 mg/mL of cefdinir. Chromatographic system (See Chromatography 621, System Suitability.) Mode: LC Detector: UV 254 nm Column: 4.6-mm × 15-cm; 5-µm packing L1 Column temperature: 40 Autosampler temperature: 4 Flow rate: 1 mL/min Injection size: 10 µL System suitability Samples: System suitability solution and Standard solution Suitability requirements Resolution: NLT 1.5 between cefdinir and the third peak of the USP Cefdinir Related Compound A RS, System suitability solution Tailing factor: NMT 1.5 for cefdinir related compound B, System suitability solution Relative standard deviation: NMT 2.0% for the cefdinir peak response, Standard solution Analysis Samples: Standard solution and Sample solution Calculate the percentage of each impurity in the portion of Capsules taken: Result = (rU/rS) × (CS/CU) × (100/F) rU = = peak response of each impurity from the Sample solution rS = = peak response from the Standard solution CS = = concentration of the Standard solution (mg/mL) CU = = nominal concentration of cefdinir in the Sample solution (mg/mL) F = = relative response factor (see Table 2) Acceptance criteria: See Table 2. Table 2 Name Relative Retention Time Relative Response Factor Reporting Threshold (% Cefdinir) Acceptance Criteria, NMT (%) Thiazolylacetyl glycine oximea 0.10 1.1 0.1 0.5 Thiazolylacetyl glycine oxime acetalb 0.13 1.1 0.1 0.5 Cefdinir sulfoxidec 0.36 1.0 0.05 0.2 Cefdinir thiazine analogd 0.46 1.5 0.05 0.7 3-Methyl cefdinire 0.75 1.0 0.05 0.7 Cefdinir impurity 1f 0.77 1.0 0.05 0.3 Cefdinir related compound A (cefdinir open ring lactone a)g,h 0.85 1.5 0.1 2.5 Cefdinir related compound A (cefdinir open ring lactone b)g,h 0.94 1.5 0.1 Cefdinir related compound A (cefdinir open ring lactone c)g,h 1.11 1.5 0.1 Cefdinir related compound A (cefdinir open ring lactone d)g,h 1.14 1.5 0.1 7S-Cefdiniri 1.18 1.1 0.05 0.2 Cefdinir lactonej 1.23 1.2 0.05 1.0 Cefdinir related compound Bk 1.28 1.1 0.05 0.2 Cefdinir isoxazole analogl 1.37 1.4 0.05 0.5 Cefdinir impurity 2 f (ERR 1-Aug-2013) 1.44 1.0 0.05 0.5 Cefdinir glyoxalic analogm 1.49 1.0 0.05 0.2 E-cefdinirn 1.51 1.1 0.05 0.7 Cefdinir decarboxy open ring lactone ao,p 1.62 1.3 0.05 1.0 Cefdinir decarboxy open ring lactone bo,p 1.64 1.3 0.05 Cefdinir impurity 3 f (ERR 1-Aug-2013) 1.82 1.0 0.05 0.2 Individual unidentified impurities — 1.0 0.05 0.2 Total impurities — — — 5.0 a N-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetyl]glycine. b (Z)-2-(2-Aminothiazol-4-yl)-N-(2,2-dihydroxyethyl)-2-(hydroxyimino)acetamide. c (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-5,8-dioxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. d (R,Z)-2-{(R)-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido](carboxy)methyl}-5-ethylidene-5,6-dihydro-2H-1,3-thiazine-4-carboxylic acid. e (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. f Cefdinir impurity 1, cefdinir impurity 2, and cefdinir impurity 3 are unidentified impurities. g Cefdinir related compound A is a mixture of 4 isomers labeled cefdinir open ring lactones a, b, c, and d. The sum of the values is reported. The limit for the sum of the 4 isomers is 2.5%. h 2(R)-2-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-2-[(2RS,5RS)-5-methyl-7-oxo-2,4,5,7-tetrahydro-1H-furo[3,4-d][1,3]thiazin-2-yl]acetic acid. i (6R,7S)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. j (Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)-N-((3RS,5aR,6R)-3-methyl-1,7-dioxo-1,3,4,5a,6,7-hexahydroazeto[2,1-b]furo[3,4-d][1,3]thiazin-6-yl)acetamide. k (6R,7R)-7-[2-(2-Amino-4-thiazolyl)acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. l (6R,7R)-7-(4-Hydroxyisoxazole-3-carboxamido)-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. m (6R,7R)-7-[2-(2-Aminothiazol-4-yl)-2-oxoacetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. n (6R,7R)-7-[(E)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. o Cefdinir decarboxy open ring lactone is a mixture of 2 isomers labeled cefdinir decarboxy open ring lactone a and b. The sum of the values is reported. The limit for sum of the 2 isomers is 1.0%. p (Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)-N-{[(2RS,5RS)-5-methyl-7-oxo-2,4,5,7-tetrahydro-1H-furo[3,4-d][1,3]thiazin-2-yl]methyl}acetamide. ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight light-resistant containers, and store at controlled room temperature. • USP Reference Standards 11 USP Cefdinir RS USP Cefdinir Related Compound A RS (2R)-2-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-2-[(2RS,5RS)-5-methyl-7-oxo-2,4,5,7-tetrahydro-1H-furo[3,4-d][1,3]thiazin-2-yl]acetic acid (three other stereoisomers are also present in this RS). C14H15N5O6S2 413.43 USP Cefdinir Related Compound B RS (6R,7R)-7-[2-(2-Amino-4-thiazolyl)acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. C14H13N4O4S2 365.41 Auxiliary Information— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee Monograph Ahalya Wise, M.S. Senior Scientific Liaison (301) 816-8161 (SM12010) Monographs - Small Molecules 1 711 Margareth R.C. Marques, Ph.D. Senior Scientific Liaison (301) 816-8106 (GCDF2010) General Chapters - Dosage Forms Reference Standards RS Technical Services 1-301-816-8129 rstech@usp.org USP37–NF32 Page 2194 Pharmacopeial Forum: Volume No. 36(6) Page 1511 Chromatographic Column— CEFDINIR CAPSULES Chromatographic columns text is not derived from, and not part of, USP 37 or NF 32. |
2樓2014-08-01 10:57:00
dingjinglvde
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【答案】應(yīng)助回帖
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Cefdinir for Oral Suspension DEFINITION Cefdinir for Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of cefdinir (C14H13N5O5S2). It may contain one or more suitable buffers, flavors, preservatives, stabilizing agents, sweeteners, and suspending agents. IDENTIFICATION • A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. ASSAY • Procedure Buffer: 10.7 mg/mL of anhydrous dibasic sodium phosphate and 3.4 mg/mL of monobasic potassium phosphate in water. Adjust with phosphoric acid or sodium hydroxide to a pH of 7.0 ± 0.05 before final dilution. Solution A: 7 mg/mL of citric acid monohydrate. Adjust with phosphoric acid to a pH of 2.0 ± 0.05. Mobile phase: Methanol, tetrahydrofuran, and Solution A (111:28:1000) System suitability solution: 50 µg/mL of USP Cefdinir RS and 175 µg/mL of m-hydroxybenzoic acid in Buffer Standard solution: 50 µg/mL of USP Cefdinir RS in Buffer Sample solution: Equivalent to 50 µg/mL of cefdinir from constituted Cefdinir for Oral Suspension in Buffer Chromatographic system (See Chromatography 621, System Suitability.) Mode: LC Detector: UV 254 nm Column: 3.9-mm × 15-cm; 4-µm packing L1 Flow rate: 1.4 mL/min Injection volume: 15 µL System suitability Samples: System suitability solution and Standard solution Suitability requirements Resolution: NLT 3.0 between cefdinir and m-hydroxybenzoic acid, System suitability solution Tailing factor: NMT 2.0 for cefdinir, System suitability solution Relative standard deviation: NMT 1.0% for cefdinir, Standard solution Analysis Samples: Standard solution and Sample solution Calculate the percentage of the labeled amount of cefdinir (C14H13N5O5S2) in the portion of Cefdinir for Oral Suspension taken: Result = (rU/rS) × (CS/CU) × 100 rU = = peak response of cefdinir from the Sample solution rS = = peak response of cefdinir from the Standard solution CS = = concentration of the Standard solution (µg/mL) CU = = nominal concentration of cefdinir in the Sample solution (µg/mL) Acceptance criteria: 90.0%–110.0% PERFORMANCE TESTS • Dissolution 711 Medium: 0.05 M phosphate buffer, pH 6.8; 900 mL Apparatus 2: 50 rpm Time: 30 min Detector: UV 290 nm Standard solution: 0.14 mg/mL of USP Cefdinir RS in Medium Sample solution: Transfer 5 mL, by weight, of the reconstituted Cefdinir for Oral Suspension into the vessel. After the appropriate time, withdraw a portion of the solution under test, and pass through a suitable filter of 0.45-µm pore size. Dilute a portion of each filtered sample with Medium as necessary to obtain a solution having a concentration of about 0.14 mg/mL of cefdinir. Blank: Medium Analysis Samples: Standard solution and Sample solution Determine the percentage of the labeled amount of cefdinir (C14H13N5O5S2) dissolved: Result = (AU/AS) × [(CS × d × D × V)/W × L] × 100 AU = = absorbance of the Sample solution AS = = absorbance of the Standard solution CS = = concentration of the Standard solution (mg/mL) d = = density of the Cefdinir for Oral Suspension (mg/mL) D = = dilution factor of the Sample solution (mL/mL) V = = volume of Medium, 900 mL W = = weight of Cefdinir for Oral Suspension taken (mg) L = = label claim (mg/mL) Tolerances: NLT 80% (Q) of the labeled amount of cefdinir (C14H13N5O5S2) is dissolved. • Uniformity of Dosage Units 905: Meets the requirements for solids packaged in single-unit containers • Deliverable Volume 698: For solids packaged in single-unit containers, meets the requirements IMPURITIES • Organic Impurities Solution A: 14.2 mg/mL of anhydrous dibasic sodium phosphate Solution B: 13.6 mg/mL of monobasic potassium phosphate Buffer: Combine appropriate amounts of Solution A and Solution B (about 2:1) to obtain a solution with a pH of 7.0 ± 0.1. Solution C: Dilute tetramethylammonium hydroxide (10% aqueous) with water to obtain a 0.1% solution. Adjust with dilute phosphoric acid (1 in 10) to a pH of 5.5 ± 0.1. Solution D: 37.2 mg/mL of edetate disodium Solution E: To 1000 mL of Solution C add 0.4 mL of Solution D. Solution F: Acetonitrile, methanol, Solution C, and Solution D (150: 100: 250: 0.2) Mobile phase: See Table 1. Table 1 Time (min) Solution E (%) Solution F (%) 0 95 5 2 95 5 22 75 25 32 50 50 37 50 50 38 95 5 58 95 5 System suitability stock solution 1: 40 µg/mL of USP Cefdinir Related Compound A RS in Solution C System suitability stock solution 2: 40 µg/mL of USP Cefdinir Related Compound B RS in Buffer System suitability solution: Transfer 37.5 mg of USP Cefdinir RS to a 25-mL volumetric flask, and add about 10 mL of Buffer. Add 5.0 mL each of System suitability stock solution 1 and System suitability stock solution 2, and dilute with Solution C to volume. Standard stock solution: 750 µg/mL of USP Cefdinir RS in Buffer Standard solution: 15 µg/mL of USP Cefdinir RS from the Standard stock solution in Solution C Sample solution: Transfer a quantity equivalent to 150 mg of cefdinir from the constituted Cefdinir for Oral Suspension to a 100-mL volumetric flask. Dissolve in 30 mL of Buffer, and dilute with Solution C to volume. Chromatographic system (See Chromatography 621, System Suitability.) Mode: LC Detector: UV 254 nm Column: 4.6-mm × 15-cm; 5-µm packing L1 Temperatures Column: 40 Autosampler: 4 Flow rate: 1 mL/min Injection volume: 10 µL System suitability Samples: System suitability solution and Standard solution Suitability requirements Resolution: NLT 1.5 between cefdinir and the third peak for USP Cefdinir Related Compound A RS, System suitability solution Tailing factor: NMT 1.5 for cefdinir related compound B, System suitability solution Relative standard deviation: NMT 2.0% for the cefdinir peak, Standard solution Analysis Samples: Standard solution and Sample solution Calculate the percentage of each impurity in the portion of Cefdinir for Oral Suspension taken: Result = (rU/rS) × (CS/CU) × 100/F rU = = peak response of each impurity from the Sample solution rS = = peak response of cefdinir from the Standard solution CS = = concentration of the Standard solution (mg/mL) CU = = nominal concentration of cefdinir in the Sample solution (mg/mL) F = = relative response factor (see Table 2) Acceptance criteria: See Table 2. Table 2 Name Relative Retention Time Relative Response Factor Reporting Threshold (% Cefdinir) Acceptance Criteria, NMT (%) Thiazolylacetyl glycine oximea 0.10 1.1 0.1 0.5 Thiazolylacetyl glycine oxime acetalb 0.13 1.1 0.1 0.6 Cefdinir sulfoxidec 0.36 1.0 0.05 0.2 Cefdinir thiazine analogd 0.46 1.5 0.05 0.3 3-Methyl cefdinire 0.75 1.0 0.05 0.7 Cefdinir impurity 1f 0.77 1.0 0.05 0.2 Cefdinir related compound A (cefdinir open ring lactone a)g,h 0.85 1.5 0.1 3.3 Cefdinir related compound A (cefdinir open ring lactone b)g,h 0.94 1.5 0.1 Cefdinir related compound A (cefdinir open ring lactone c)g,h 1.11 1.5 0.1 Cefdinir related compound A (cefdinir open ring lactone d)g,h 1.14 1.5 0.1 7S-Cefdiniri 1.18 1.1 0.05 0.2 Cefdinir lactonej 1.23 1.2 0.05 0.8 Cefdinir related compound Bk 1.28 1.1 0.05 0.2 Cefdinir isoxazole analogl 1.37 1.4 0.05 0.5 Cefdinir impurity 2f 1.44 1.0 0.05 0.2 Cefdinir glyoxalic analogm 1.49 1.0 0.05 0.2 E-Cefdinirn 1.51 1.1 0.05 1.2 Cefdinir decarboxy open ring lactone ao,p 1.62 1.3 0.05 1.1 Cefdinir decarboxy open ring lactone bo,p 1.64 1.3 0.05 Cefdinir impurity 3f 1.82 1.0 0.05 0.2 Individual unidentified impurities — 1.0 0.05 0.2 Total impurities — — — 6.2 a N-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetyl]glycine. b (Z)-2-(2-Aminothiazol-4-yl)-N-(2,2-dihydroxyethyl)-2-(hydroxyimino)acetamide. c (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-5,8-dioxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. d (R,Z)-2-{(R)-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido](carboxy)methyl}-5-ethylidene-5,6-dihydro-2H-1,3-thiazine-4-carboxylic acid. e (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. f Cefdinir impurity 1, cefdinir impurity 2, and cefdinir impurity 3 are unidentified impurities. g Cefdinir related compound A is a mixture of four isomers labeled cefdinir open ring lactones a, b, c, and d. The sum of the values is reported; the limit for the sum of the four isomers is 3.3%. h 2(R)-2-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-2-[(2RS,5RS)-5-methyl-7-oxo-2,4,5,7-tetrahydro-1H-furo[3,4-d][1,3]thiazin-2-yl]acetic acid. i (6R,7S)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. j (Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)-N-((3RS,5aR,6R)-3-methyl-1,7-dioxo-1,3,4,5a,6,7-hexahydroazeto[2,1-b]furo[3,4-d][1,3]thiazin-6-yl)acetamide. k (6R,7R)-7-[2-(2-Amino-4-thiazolyl)acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. l (6R,7R)-7-(4-Hydroxyisoxazole-3-carboxamido)-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. m (6R,7R)-7-[2-(2-Aminothiazol-4-yl)-2-oxoacetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. n (6R,7R)-7-[(E)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. o Cefdinir decarboxy open ring lactone is a mixture of two isomers labeled cefdinir decarboxy open ring lactone a and b. The sum of the values is reported; the limit for the sum of the two isomers is 1.1%. p (Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)-N-{[(2RS,5RS)-5-methyl-7-oxo-2,4,5,7-tetrahydro-1H-furo[3,4-d][1,3]thiazin-2-yl]methyl}acetamide. SPECIFIC TESTS Change to read: • pH 791: 3.2–4.8 (RB 1-Jun-2013) ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight, light-resistant containers, and store at controlled room temperature. • Labeling: The label specifies the directions for the constitution of the powder and states the equivalent amount of cefdinir (C14H13N5O5S2) in a given volume of Cefdinir for Oral Suspension after constitution. • USP Reference Standards 11 USP Cefdinir RS USP Cefdinir Related Compound A RS (2R)-2-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-2-[(2RS,5RS)-5-methyl-7-oxo-2,4,5,7-tetrahydro-1H-furo[3,4-d][1,3]thiazin-2-yl]acetic acid (three other stereoisomers are also present in this RS). C14H15N5O6S2 413.43 USP Cefdinir Related Compound B RS (6R,7R)-7-[2-(2-Amino-4-thiazolyl)acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo](4.2.0)]oct-2-ene-2-carboxylic acid. C14H13N4O4S2 365.41 Auxiliary Information— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee Monograph Ahalya Wise, M.S. Senior Scientific Liaison (301) 816-8161 (SM12010) Monographs - Small Molecules 1 711 Margareth R.C. Marques, Ph.D. Senior Scientific Liaison (301) 816-8106 (GCDF2010) General Chapters - Dosage Forms Reference Standards RS Technical Services 1-301-816-8129 rstech@usp.org USP37–NF32 Page 2196 Pharmacopeial Forum: Volume No. 36(6) Page 1515 Chromatographic Column— CEFDINIR FOR ORAL SUSPENSION Chromatographic columns text is not derived from, and not part of, USP 37 or NF 32. |
3樓2014-08-01 10:57:39
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