PHR1038

Clarithromycin

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : CLM
• Formule empirique (notation de Hill): C₃₈H₆₉NO₁₃
• Numéro CAS: 81103-11-9
• Poids moléculaire : 747.95
• Numéro MDL: MFCD00865140
• Code UNSPSC : 41116107
• ID de substance PubChem : 329823068
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to BP 833; traceable to Ph. Eur. Y0000320; traceable to USP 1134379
• Famille d'API: clarithromycin
• CofA (certificat d'analyse): current certificate can be downloaded
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: -10 to -25°C
• Chaîne SMILES: 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
• Clé InChI: AGOYDEPGAOXOCK-KCBOHYOISA-N

Description

Description générale

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.

Application

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.

Actions biochimiques/physiologiques

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.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

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.

Produits recommandés

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Informations sur la sécurité

• Pictogrammes: GHS07
• Mention d'avertissement: Warning
• Mentions de danger: H302
• Conseils de prudence: P301 + P312 + P330
• Classification des risques: Acute Tox. 4 Oral
• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 1
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable