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PHR1763

Supelco

Cefepime hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Cefepime hydrochloride, Cefepime dihydrochloride monohydrate

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1 G
€226.00

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1 G
€226.00

About This Item

Linear Formula:
C19H25N6O5S2Cl · HCl · H2O
CAS Number:
Molecular Weight:
571.50
UNSPSC Code:
41116107
NACRES:
NA.24

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grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to Ph. Eur. Y0000633
traceable to USP 1097636

API family

cefepime

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

[s]1[c]([nH]c(c1)\C(=N\OC)\C(=O)N[C@H]2[C@H]3SCC(=C(N3C2=O)C(=O)[O-])C[N+]4(CCCC4)C)=N.Cl.Cl.O

InChI

1S/C19H24N6O5S2.2ClH.H2O/c1-25(5-3-4-6-25)7-10-8-31-17-13(16(27)24(17)14(10)18(28)29)22-15(26)12(23-30-2)11-9-32-19(20)21-11;;;/h9,13,17H,3-8H2,1-2H3,(H3-,20,21,22,26,28,29);2*1H;1H2/b23-12-;;;/t13-,17-;;;/m1.../s1

InChI key

LRAJHPGSGBRUJN-OMIVUECESA-N

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General description

Cefepime hydrochloride is one of the fourth-generation, semisynthetic, broad-spectrum, cephalosporin β-lactam antibiotic drugs administered parenterally in patients with moderate-to-severe infections like pneumonia, uncomplicated urinary tract infections, skin and soft tissue infections, etc. Its mode of action involves the penetration of outer cell wall of gram negative bacteria.[1]
Pharmaceutical secondary standard for application in quality control. Provides pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Cefepime hydrochloride has been used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by spectrophotometry[2] and chromatography[3][1][4] techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB8503 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Certificates of Analysis (COA)

Lot/Batch Number

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Analysis of N-methylpyrrolidine in cefepime hydrochloride by ion chromatography using suppressed conductivity detection with solid-phase extraction pre-treatment
Page N, et al.
Analytical Methods for Therapeutic Drug Monitoring and Toxicology, 6(4), 1248-1253 (2014)
Spectrophotometric determination of cefepime hydrochloride, cefoperazone sodium, ceftazidime pentahydrate. cefuroxime sodium and etamsylate using ammonium molybdate
Elazazy M, et al.
Scientia Pharmaceutica, 71(3), 211-228 (2003)
RP-HPLC method for simultaneous estimation of cefepime hydrochloride and tazobactam sodium in bulk and pharmaceuticals
Tamboli SR and Patil DD
Journal of Chemistry, 2013(4), 1248-1253 (2013)
Development and validation of a green analytical method of RP-HPLC for quantification of Cefepime hydrochloride in pharmaceutical dosage form: Simple, sensitive and economic
Rodrigues DF and Salgado HRN
Current Pharmaceutical Analysis, 12(4), 306-314 (2016)
Lokender Kumar et al.
Frontiers in microbiology, 12, 598498-598498 (2021-02-16)
Pseudomonas aeruginosa utilizes the quorum sensing (QS) system to strategically coordinate virulence and biofilm formation. Targeting QS pathways may be a potential anti-infective approach to treat P. aeruginosa infections. In the present study, we define cephalosporins' anti-QS activity using Chromobacterium

Questions

1–2 of 2 Questions  
  1. I'd like to know hos I can solubilize thie product (Cefepime PHR1763) and what is the solubility limit. Thanks in advance.

    1 answer
    1. Cefepime hydrochloride is soluble in several solvents. It is highly soluble in water and normal saline and it can also be dissolved in dextrose solutions. It is also easily soluble in methanol and diethylether and slightly soluble in ethanol, but concentrations will need to be determined empirically in all cases, as solubility is not tested internally.

      Helpful?

  2. May I know what is the recommended media for reconstitution? I would also like to know if there is any information pertaining to the estimated shelf life for both the neat and the working solution.

    1 answer
    1. PHR1763, Cefepime hydrochloride is a Pharmaceutical Secondary Standard, intended for use in compendial testing. The preparation of the standard is per the relevant compendial monograph. The shelf life for the solid neat product is per the expiration date on the accompanying COA - a sample COA can be found in the document section of the product webpage (linked below). Shelf life of the prepared solutions is per the applicable monograph or general chapter.
      https://www.sigmaaldrich.com/CA/en/product/sial/phr1763#product-documentation

      Helpful?

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