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PHR1038

Supelco

Clarithromycin

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):
CLM
Empirical Formula (Hill Notation):
C38H69NO13
Número CAS:
Peso molecular:
747.95
Número MDL:
ID de substância PubChem:
NACRES:
NA.24

Nível de qualidade

300

grau

certified reference material
pharmaceutical secondary standard

Certificado de análise (CofA)

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

formato

neat

rastreabilidade da farmacopeia

traceable to BP 833
traceable to PhEur Y0000320
traceable to USP 1134379

temperatura de armazenamento

-10 to -25°C

SMILES string

O[C@@H]([C@@](O)(C)[C@@H](CC)OC([C@H](C)[C@H]1O[C@@H]2O[C@@H](C)[C@H](O)[C@](C)(OC)C2)=O)[C@@H](C)C([C@H](C)C[C@@](C)(OC)[C@H](O[C@@H]3O[C@H](C)C[C@H](N(C)C)[C@H]3O)[C@H]1C)=O

InChI

1S/C38H69NO13/c1-15-26-38(10,45)31(42)21(4)28(40)19(2)17-37(9,47-14)33(52-35-29(41)25(39(11)12)16-20(3)48-35)22(5)30(23(6)34(44)50-26)51-27-18-36(8,46-13)32(43)24(7)49-27/h19-27,29-33,35,41-43,45H,15-18H2,1-14H3/t19-,20-,21+,22+,23-,24+,25+,26-,27+,29-,30+,31-,32+,33-,35+,36-,37-,38-/m1/s1

InChI key

AGOYDEPGAOXOCK-KCBOHYOISA-N

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Descrição geral

Clarithromycin belongs to the group of macrolide erythromycin antibiotics. Owing to its broad-spectrum antibacterial activity, several dosage forms of clarithromycin have been formulated. It is widely utilized to treat the infections caused by Chlamydia, Mycoplasma, Legionella, Helicobacter pylori, and Mycobacterium avium complex. It is also known to be active against HIV-related opportunistic infections.

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.

Aplicação

Clarithromycin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by ultra-performance liquid chromatography (UPLC), high performance liquid chromatography (HPLC) and time-of-flight-secondary ion mass spectrometry (ToF-SIMS) techniques. It can be used as a reference standard in validating the concentration of clarithromycin in human plasma samples using liquid chromatography coupled with tandem mass spectrometry (LC-MS-MS). Clarithromycin may also be used as a test reference standard to validate and compare its purity using two different types of methods, quantitative nuclear magnetic resonance (qNMR) and high performance liquid chromatography (HPLC).
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.

Ações bioquímicas/fisiológicas

Clarithromycin is a macrolide antibiotic that interferes with bacterial protein synthesis. Clarithromycin is an acid-stable version of erythromycin and is particularly effective against Gram-negative bacteria. It has a short half-life, however its metabolite, 14-hydroxy clarithromycin is nearly twice as active as clarithromycin against certain bacteria.

Nota de análise

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

Outras notas

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.

Nota de rodapé

To see an example of a Certificate of Analysis for this material enter LRAC0293 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictogramas

Exclamation mark

Palavra indicadora

Warning

Frases de perigo

Declarações de precaução

Classificações de perigo

Acute Tox. 4 Oral

Código de classe de armazenamento

11 - Combustible Solids

WGK

WGK 1

Ponto de fulgor (ºF)

Not applicable

Ponto de fulgor (ºC)

Not applicable

Certificado de análise

Certificado de origem

Formulation of an intravenous emulsion loaded with a clarithromycin-phospholipid complex and its pharmacokinetics in rats
Lu Y, et al.
International Journal of Pharmaceutics, 366(1-2), 160-169 (2009)
Simplified method for determination of clarithromycin in human plasma using protein precipitation in a 96-well format and liquid chromatography?tandem mass spectrometry
Shin J, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 871, 130-134 (2008)
A comparative uncertainty study of the calibration of macrolide antibiotic reference standards using quantitative nuclear magnetic resonance and mass balance methods
Liu Y-S and Hu Q-C
Analytica Chimica Acta, 602, 114-121 (2007)
Possibility of monitoring granulation by analyzing the amount of hydroxypropylcellulose, a binder on the surface of granules, using ToF-SIMS
Furudate T, et al.
International Journal of Pharmaceutics, 495(2), 642-650 (2015)
Simultaneous Determination Of Omeprazole, Tinidazole and Clarithromycin in Bulk powder and Helicure? Tablets by HPLC
Salem H, et al.
Journal of Chromatography and Separation Techniques, 5(2), 1-1 (2014)

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