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Merck

PHR1038

Clarithromycin

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

CLM

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About This Item

Empirical Formula (Hill Notation):
C38H69NO13
CAS Number:
81103-11-9
Molecular Weight:
747.95
NACRES:
NA.24
PubChem Substance ID:
329823068
UNSPSC Code:
41116107
MDL number:
MFCD00865140

Key Documents

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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

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 key

AGOYDEPGAOXOCK-KCBOHYOISA-N

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0000320, traceable to USP 1134379

API family

clarithromycin

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

-10 to -25°C

Quality Level

300

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General description

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.

Biochem/physiol Actions

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.

Analysis Note

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

Other Notes

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.
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 LRAC0293 in the slot below. This is an example certificate only and may not be the lot that you receive.

signalword

Warning

Storage Class

11 - Combustible Solids

flash_point_f

Not applicable

flash_point_c

Not applicable

pictograms

Exclamation markEnvironment
GHS07,GHS09

hcodes

H302,H410

Hazard Classifications

Acute Tox. 4 Oral - Aquatic Acute 1 - Aquatic Chronic 1

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

Class I Designated Chemical Substances

prtr

Substances Subject to be Indicated Names

ishl_indicated

Substances Subject to be Notified Names

ishl_notified

PHR1038-500MG-PW: + PHR1038-500MG: + 16632-500MG: + PHR1038-500MG-BULK: + 16632-500MG-BULK:

jan

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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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)
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)
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)
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)
View All Related Papers

Articles

LC-MS Analysis of Serum for a Wide Analyte Range Using a Novel HLB SPE Phase

Analysis of 20 pharmaceutical compounds in calf serum using Supel™ Swift HLB SPE cartridge for cleanup and LC-MS determination and another commercially available HLB cartridge for comparison.

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