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wells6860

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[求助] 求助USP37标准！！

各位大侠，急求头孢地尼（Cefdinir）胶囊和口服混悬剂的USP37标准！小弟先谢过了！！！
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nick123

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【答案】应助回帖

★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ★ ...
感谢参与，应助指数 +1
wells6860: 金币+55, ★★★★★最佳答案, 谢谢兄弟！要的就是pdf的，但不知道什么原因，最近迅雷网盘总下不下来，再加5个币，能不能劳烦兄弟向邮箱里发一份啊！wzquan132@163.com，谢谢啊！ 2014-08-01 11:57:18
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dingjinglvde

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【答案】应助回帖

★ ★ ★ ★ ★
感谢参与，应助指数 +1
wells6860: 金币+5, 虽然不是pdf的，但还是十分感谢啊！ 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.
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dingjinglvde

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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.
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4楼: Originally posted by nick123 at 2014-08-01 11:11:32
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不好意思兄弟，刚又试了以下能下载了，不用发邮箱了，谢谢啊！
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