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PHR1848

Supelco

Cephalexin

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Cephalexin monohydrate
Empirical Formula (Hill Notation):
C16H17N3O4S · H2O
CAS Number:
Molecular Weight:
365.40
EC Number:
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 61
traceable to Ph. Eur. C0675000
traceable to USP 1099008

API family

cephalexin

CofA

current certificate can be downloaded

packaging

pkg of 1 g

application(s)

pharmaceutical

format

neat

storage temp.

2-30°C

InChI

1S/C16H17N3O4S.H2O/c1-8-7-24-15-11(14(21)19(15)12(8)16(22)23)18-13(20)10(17)9-5-3-2-4-6-9;/h2-6,10-11,15H,7,17H2,1H3,(H,18,20)(H,22,23);1H2/t10-,11-,15-;/m1./s1

InChI key

AVGYWQBCYZHHPN-CYJZLJNKSA-N

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.
Cephalexin is a cephalosporine which is categorized under the class of β-lactam antibiotics. It is utilized for regulating the effects of Gram-positive and Gram-negative bacteria. It favors the lysis of bacterial cell wall by inhibiting the synthesis of essential structural components. Cephalexin belongs to the safest group of broad-spectrum bactericidal antimicrobial agents.

Application

Cephalexin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and water 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, 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 LRAC0286 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

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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Application of thin layer and high performance liquid chromatography to the separation and determination of cephalexin in cephradine, in bulk powder and in pharmaceuticals.
Crombez E, et al.
Chromatographia, 11(11), 653-657 (1978)
A validated stability indicating HPTLC method for determination of cephalexin in bulk and pharmaceutical formulation.
Jeswani RM, et al.
International Journal of PharmTech Research, 1(3), 527-536 (2009)
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, Biomedical Sciences and Applications, 788(1), 147-158 (2003)
Determination of multiple pharmaceutical classes in surface and ground waters by liquid chromatography-ion trap-tandem mass spectrometry.
Grujic S, et al.
Journal of Chromatography A, 1216(25), 4989-5000 (2009)
Comparison of several methods used for the determination of cephalosporins. Analysis of cephalexin in pharmaceutical samples.
Martinez LG, et al.
Journal of Pharmaceutical and Biomedical Analysis, 29(3), 405-423 (2002)

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