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PHR1088

Azithromycin

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

Azithromycin dihydrate, 1-Oxa-6-azacyclopentadecan-15-one, 13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-alpha-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10- trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-beta-D-xylohexopyranosyl]oxy]-, [2R-(2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)]- dihydrate, N-Methyl-11-aza-10-deoxo-10-dihydroerythromycin A, CP-62993

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Acerca de este artículo

Fórmula empírica (notación de Hill):
C38H72N2O12 · 2H2O
Número CAS:
117772-70-0
Peso molecular:
785.02
NACRES:
NA.24
PubChem Substance ID:
329823110
UNSPSC Code:
41116107
MDL number:
MFCD01862248
Servicio técnico
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0000306, traceable to USP 1046056

API family

azithromycin

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

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

InChI key

SRMPHJKQVUDLQE-KUJJYQHYSA-N

General description

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

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.
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.

Biochem/physiol Actions

Azithromycin dihydrate is a macrolide antibiotic with anti-immunomodulatory/anti-inflammatory properties.
Azithromycin dihydrate is a macrolide antibiotic, azalide subclass. It binds to the 50S subunit of the 70S bacterial ribosomes and inhibits RNA-dependent protein synthesis in bacterial cells. Azithromycin also has anti-immunomodulatory/anti-inflammatory properties, which make it useful in treating cystic fibrosis.

Analysis Note

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

Other Notes

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 LRAB3758 in the slot below. This is an example certificate only and may not be the lot that you receive.

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Clase de almacenamiento

11 - Combustible Solids

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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LC determination of impurities in azithromycin tablets
Miguel L and Barbas C
Journal of Pharmaceutical and Biomedical Analysis, 33(2), 211-217 (2003)
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)
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)
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