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Merck
CN

PHR1038

克拉霉素

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

CLM

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关于此项目

经验公式(希尔记法):
C38H69NO13
化学文摘社编号:
分子量:
747.95
NACRES:
NA.24
PubChem Substance ID:
UNSPSC Code:
41116107
MDL number:
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产品名称

克拉霉素, Pharmaceutical Secondary Standard; Certified Reference Material

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

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Biochem/physiol Actions

克拉霉素是一种大环内酯类抗生素,能干扰细菌蛋白质的合成。克拉霉素是红霉素的酸稳定形式,对革兰氏阴性细菌特别有效。它的半衰期很短,但是其代谢产物 14-羟基克拉霉素对某些细菌的活性几乎是克拉霉素的两倍。

Analysis Note

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

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.

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.

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.

pictograms

Exclamation mark

signalword

Warning

hcodes

Hazard Classifications

Acute Tox. 4 Oral

存储类别

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

法规信息

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分析证书(COA)

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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)
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)
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)

商品

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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