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Merck

PHR1088

Supelco

Azithromycin

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(e):

Azithromycin Dihydrat, N-Methyl-11-aza-10-deoxo-10-dihydroerythromycin A, CP-62993

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About This Item

Empirische Formel (Hill-System):
C38H72N2O12 · 2H2O
CAS-Nummer:
Molekulargewicht:
785.02
MDL-Nummer:
UNSPSC-Code:
41116107
PubChem Substanz-ID:
NACRES:
NA.24

Qualität

certified reference material
pharmaceutical secondary standard

Qualitätsniveau

Agentur

traceable to Ph. Eur. Y0000306
traceable to USP 1046056

API-Familie

azithromycin

Analysenzertifikat (CofA)

current certificate can be downloaded

Methode(n)

HPLC: suitable
gas chromatography (GC): suitable

Anwendung(en)

pharmaceutical (small molecule)

Format

neat

Lagertemp.

-10 to -25°C

SMILES String

O.O.CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]3O[C@H](C)C[C@@H]([C@H]3O)N(C)C)[C@](C)(O)C[C@@H](C)CN(C)[C@H](C)[C@@H](O)[C@]1(C)O

InChI

1S/C38H72N2O12.2H2O/c1-15-27-38(10,46)31(42)24(6)40(13)19-20(2)17-36(8,45)33(52-35-29(41)26(39(11)12)16-21(3)48-35)22(4)30(23(5)34(44)50-27)51-28-18-37(9,47-14)32(43)25(7)49-28;;/h20-33,35,41-43,45-46H,15-19H2,1-14H3;2*1H2/t20-,21-,22+,23-,24-,25+,26+,27-,28+,29-,30+,31-,32+,33-,35+,36-,37-,38-;;/m1../s1

InChIKey

SRMPHJKQVUDLQE-KUJJYQHYSA-N

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Allgemeine Beschreibung

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.

Anwendung

Azithromycin may be used as a pharmaceutical reference standard for the determination of the analyte in plasma/serum samples and pharmaceutical formulations 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.

Biochem./physiol. Wirkung

Azithromycin Dihydrat ist ein Makrolid-Antibiotikum, der Azalid Unterklasse. Es bindet an die 50S-Untereinheit des 70S bakterieller Ribosomen und hemmt die RNA-abhängige Protein-Synthese in Bakterienzellen. Azithromycin hat auch immunmodulierende/entzündungshemmende Eigenschaften, diese sind nützlich bei der Behandlung von zystischer Fibrose.

Hinweis zur Analyse

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

Sonstige Hinweise

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.

Fußnote

To see an example of a Certificate of Analysis for this material enter LRAB3758 in the slot below. This is an example certificate only and may not be the lot that you receive.

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WGK

WGK 3

Flammpunkt (°F)

Not applicable

Flammpunkt (°C)

Not applicable


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Analysenzertifikate (COA)

Lot/Batch Number

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USP

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1046023

Azithromycin-verwandte Verbindung H

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1045600

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Sigma-Aldrich

C9742

Clarithromycin

Clarithromycin 96.0-102.0% (HPLC)

Sigma-Aldrich

A3487

Clarithromycin

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Supelco

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Moxifloxacin-Hydrochlorid

Azithromycin-verwandte Verbindung F United States Pharmacopeia (USP) Reference Standard

USP

1046045

Azithromycin-verwandte Verbindung F

Ciprofloxacin HCl Pharmaceutical Secondary Standard; Certified Reference Material

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Quantitative determination of the macrolide antibiotics erythromycin, roxithromycin, azithromycin and clarithromycin in human serum by high-performance liquid chromatography using pre-column derivatization with 9-fluorenylmethyloxycarbonyl chloride and fluorescence detection
Torano JS and Guchelaar HJ
Journal of Chromatography. B, Biomedical Sciences and Applications, 720(1-2), 89-97 (1998)
Determination of erythromycin, clarithromycin, roxithromycin, and azithromycin in plasma by high-performance liquid chromatography with amperometric detection
Taninaka C, et al.
Journal of Chromatography. B, Biomedical Sciences and Applications, 738(2), 405-411 (2000)
LC determination of impurities in azithromycin tablets
Miguel L and Barbas C
Journal of Pharmaceutical and Biomedical Analysis, 33(2), 211-217 (2003)
R Hirsch et al.
Journal of periodontal research, 47(2), 137-148 (2011-11-05)
Azithromycin is a macrolide antibiotic used extensively in medicine for the treatment of a wide range of infections such as upper respiratory tract infections, middle ear infections, sexually transmitted infections and trachoma. It is also effective against the most common
Erik B Wilms et al.
Pediatric pulmonology, 47(7), 658-665 (2012-06-12)
Azithromycin maintenance therapy results in improvement of respiratory function in patients with cystic fibrosis (CF). In azithromycin maintenance therapy, several dosing schemes are applied. In this review, we combine current knowledge about azithromycin pharmacokinetics with the dosing schedules used in

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