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PHR1283

Cefaclor

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Cefaclor monohydrate

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About This Item

Empirical Formula (Hill Notation):
C15H14ClN3O4S · H2O
CAS Number:
70356-03-5
Molecular Weight:
385.82
UNSPSC Code:
41116107
EC Number:
258-909-5
NACRES:
NA.24

Key Documents

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SMILES string

S1[C@H]2N(C(=C(C1)Cl)C(=O)O)C(=O)[C@H]2NC(=O)[C@H](N)c3ccccc3.O

InChI key

WKJGTOYAEQDNIA-IOOZKYRYSA-N

InChI

1S/C15H14ClN3O4S.H2O/c16-8-6-24-14-10(13(21)19(14)11(8)15(22)23)18-12(20)9(17)7-4-2-1-3-5-7;/h1-5,9-10,14H,6,17H2,(H,18,20)(H,22,23);1H2/t9-,10-,14-;/m1./s1

grade

certified reference material, pharmaceutical secondary standard

agency

USP 1096906, traceable to Ph. Eur. C0630000

API family

cefaclor

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Quality Level

300

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General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Cefaclor belongs to the class of second generation semi-synthetic cephalosporin antibiotic drugs that is normally administered orally. With its broad-spectrum antibacterial action, cefaclor is effective against several gram-positive as well as gram-negative bacteria.

Application

Cefaclor may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and biological samples by various chromatography 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 and EP 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.
To see an example of a Certificate of Analysis for this material enter LRAC3323 in the slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class

11 - Combustible Solids

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

涉药品监管产品
This item has

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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The use of a monolithic column to improve the simultaneous determination of four cephalosporin antibiotics in pharmaceuticals and body fluids by HPLC after solid phase extraction-a comparison with a conventional reversed-phase silica-based column
Samanidou VF, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 809(1), 175-182 (2004)
Determination of cefaclor in human plasma by a sensitive and specific liquid chromatographic-tandem mass spectrometric method
Chen X, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 784(1), 17-24 (2003)
Simultaneous determination of cefpirome, cefaclor, ceftazidime, and cephradine in pharmaceutical formulations by reversed phase HPLC
Nawaz M, et al.
Acta Chromatographica , 23(2), 205-213 (2011)
Determination of process-related impurities and degradation products in cefaclor by high-performance liquid chromatography
Lorenz LJ, et al.
Journal of Chromatographic Science, 30(6), 211-216 (1992)
Rapid and sensitive high-performance liquid chromatographic determination of four cephalosporin antibiotics in pharmaceuticals and body fluids
Samanidou VF, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 788(1), 147-158 (2003)
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