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icewolf7388

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[交流] 【助已完结】头孢克肟颗粒质量标准

各位大哥，大姐：谁有头孢克肟颗粒的最新质量标准！！！

多谢了！！！

[ Last edited by junjun517 on 2010-1-29 at 15:36 ]

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小木虫(金币+0.5):给个红包，谢谢回帖交流
junjun517(金币+2):谢谢回帖交流 2010-01-28 16:18

Re:,头孢克肟质量标准

盐酸头孢吡肟 |ggtb\W
Cefepime Hydrochloride REcKfJTj
qfAnMBM1@
C19H25ClN6O5S2 ·HCl· H2O 571.50 SH" Pyrrolidinium, 1-[[7-[[(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methyl-, chloride, monohydrochloride, monohydrate, [6R -[6,7(Z)]]-. AL& 1-[[(6R, 7R )-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 72 -(Z)-(O-methyloxime), monohydrochloride, monohydrate [123171-59-5]. VqD_FS;E
» Cefepime Hydrochloride contains the equivalent of not less than 825 µg and not more than 911 µg of cefepime (C19H24N6O5S2 ) per mg, calculated on the anhydrous basis. n0K+/}m
Packaging and storage— Preserve in tight, light-resistant containers, and store at controlled room temperature. ,'<
Labeling— Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms. I"8Z'<|/\q
USP Reference standards 11 — USP Cefepime Hydrochloride RS. USP Cefepime Hydrochloride System Suitability RS. USP Endotoxin RS. fS8Pi,!
Identification, Infrared Absorption 197M . Qi qRx
Test specimen— Proceed as directed in the chapter, but do not dry. c8_,S[W
Crystallinity 695 : meets the requirements. E+ XR[p
Bacterial endotoxins 85 — Where the label states that Cefepime Hydrochloride is sterile or that it must be subjected to further processing during the preparation of injectable dosage forms, it contains not more than 0.04 USP Endotoxin Unit per mg of cefepime hydrochloride. V sL*&Fk
Water, Method I 921 : between 3.0% and 4.5%. E=bZ4 /
Residue on ignition 281 : not more than 0.1%. 8@6*d.+e
Heavy metals, Method II 231 : 0.002%. PKGqu,J,
Limit of N -methylpyrrolidine— dry%aT
Mobile phase— Prepare a filtered and degassed mixture of 0.01 N nitric acid and acetonitrile (100:1). Make adjustments if necessary (see System Suitability under Chromatography 621 ). y#O/Xw
Standard solution— Transfer about 0.16 mL of N-methylpyrrolidine, accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with water to volume, and mix. Transfer 4.0 mL of this solution to a 100-mL volumetric flask, dilute with 0.01 N nitric acid to volume, and mix. This solution contains about 0.05 mg of N-methylpyrrolidine per mL. '81Rwp
Test solution— Transfer about 100 mg of Cefepime Hydrochloride, accurately weighed, to a 10-mL volumetric flask, dissolve in and dilute with 0.01 N nitric acid to volume, and mix. [ NOTE— Use this solution within 30 minutes. ] &Ci_wDJ
Chromatographic system (see Chromatography 621 )— The liquid chromatograph is equipped with a conductivity detector and a 4.6-mm × 5-cm column that contains 5-µm packing L52. The flow rate is about 1 mL per minute. Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the retention time of N-methylpyrrolidine is not less than 8 minutes, and the relative standard deviation for replicate injections is not more than 5.0%. LG?b]'#
Procedure— Separately inject equal volumes (about 100 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the peak responses for N-methylpyrrolidine. Calculate the percentage of N-methylpyrrolidine in the portion of Cefepime Hydrochloride taken by the formula: S;{[];
1000(C/W)( r U / r S), On@p5YRwW
in which C is the concentration, in mg per mL, of N-methylpyrrolidine in the Standard solution; W is the quantity, in mg, of Cefepime Hydrochloride taken to prepare the Test solution; and r U and r S are the N-methylpyrrolidine peak responses obtained from the Test solution and the Standard solution, respectively: not more than 0.3% is found. `ih#>i_ &
Related compounds— s6oIj$
Potassium phosphate solution— Dissolve 0.68 g of monobasic potassium phosphate in 1000 mL of water. NE@P8pQ>
Solution A— Prepare a mixture of Potassium phosphate solution and acetonitrile (9:1). Adjust with a potassium hydroxide solution (2 in 100) to a pH of 5.0, filter, and degas. tqU8>d0^
Solution B— Prepare a mixture of Potassium phosphate solution and acetonitrile (1:1). Adjust with a potassium hydroxide solution (2 in 100) to a pH of 5.0, filter, and degas. d5=yAn-+=
Mobile phase— Use variable mixtures of Solution A and Solution B as directed for Chromatographic system. Make adjustments if necessary (see System Suitability under Chromatography 621 ). fydQaxCND
System suitability solution— Prepare a solution of USP Cefepime Hydrochloride System Suitability RS in Solution A containing about 1.4 mg per mL. 9kas]zQ%=P
Test solution— Transfer about 70 mg of Cefepime Hydrochloride, accurately weighed, to a 50-mL volumetric flask, dissolve in and dilute with Solution A to volume, sonicate, and mix. [ NOTE— Inject this solution immediately, or store in a refrigerator and inject within 12 hours. ] S ^@# %>
Chromatographic system (see Chromatography 621 )— The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1. The flow rate is about 1 mL per minute. The chromatograph is programmed as follows. I#CS;Yh95
Time -k3WY&9,
(minutes) Solution A Eqt>_n8
(%) Solution B :,MI,SwnS
(%) Elution toC|vn&P
0–10 100 0 isocratic Qkg([q4
10–30 100®50 0®50 linear gradient wRE2rsXoU
30–35 50 50 isocratic \'Ca%j
35–36 50®100 50®0 linear gradient 'J#uD|9)
%967#XI[y
Chromatograph the System suitability solution, and record the peak responses as directed for Procedure: the relative retention times are about 2.7 for cefepime related compound A, 4.3 for cefepime related compound B, and 1.0 for cefepime; and the resolution, R, between cefepime and cefepime related compound A is not less than 5 and between cefepime related compound A and cefepime related compound B is not less than 10. Chromatograph the Test solution, and record the peak responses as directed for Procedure: the capacity factor, k¢, is more than 0.6; the column efficiency is not less than 4000 theoretical plates; and the tailing factor is not more than 1.1. 6T A2
Procedure— Inject a volume (about 10 µL) of the Test solution into the chromatograph, record the chromatogram, and measure the peak responses. Calculate the percentage of each impurity in the portion of Cefepime Hydrochloride taken by the formula: 0XrOOYmx
100( r i / r s ), H6-{(: *<
in which r i is the peak response for each impurity; and r s is the sum of the responses for all the peaks: not more than 0.3% of cefepime related compound A is found; not more than 0.2% of cefepime related compound B is found; and not more than 0.1% of any other impurity is found. =`BPGfC b
Residual solvents 467 : meets the requirements. I K Dh)Zm
(Official January 1, 2007) "0l7%@z*)q
Other requirements— Where the label states that Cefepime Hydrochloride is sterile, it meets the requirements for Sterility under Cefepime for Injection. l j*J|%~
Assay— [=I==?2`X
Mobile phase— Dissolve 5.76 g of sodium 1-pentanesulfonate in 2000 mL of water. Adjust with glacial acetic acid to a pH of 3.4, and then with potassium hydroxide TS to a pH of 4.0. Prepare a filtered and degassed mixture of this solution and acetonitrile (94:6). Make adjustments if necessary (see System Suitability under Chromatography 621 ). q5(Z
Standard preparation— Dissolve an accurately weighed quantity of USP Cefepime Hydrochloride RS in Mobile phase to obtain a solution having a known concentration of about 1.4 mg per mL. r<L>~S>yb
Assay preparation— Transfer about 70 mg of Cefepime Hydrochloride, accurately weighed, to a 50-mL volumetric flask, dissolve in and dilute with Mobile phase to volume, and mix. 2VNfnk
Chromatographic system (see Chromatography 621 )— The liquid chromatograph is equipped with a 254-nm detector and a 3.9-mm × 30-cm column that contains packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the column efficiency is not less than 1500 theoretical plates; the tailing factor is not more than 1.7; and the relative standard deviation for replicate injections is not more than 2.0%. .Qeml4(`3
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in µg, of cefepime (C19H24N6O5S2 ) in each mg of Cefepime Hydrochloride taken by the formula: g?caE)
50(CP/W)( r U / r S ), -'!%\E;5
in which C is the concentration, in mg per mL, of USP Cefepime Hydrochloride RS in the Standard preparation; P is the content, in µg per mg, of cefepime in USP Cefepime Hydrochloride RS; W is the weight, in mg, of Cefepime Hydrochloride taken to prepare the Assay preparation; and r U and r S are the peak responses obtained from the Assay preparation and the Standard preparation, respectively. i\?P>

Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist UPkD^D,
Expert Committee : (MDANT05) Monograph Development-Antibiotics <KDl2>O
USP29–NF24 Page 409 J12 ZdC'O
Pharmacopeial Forum : Volume No. 29(5) Page 1437 zSi SZMP"
Phone Number : 1-301-816-8223