PHR1088

Azithromycin

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(e): Azithromycin Dihydrat, N-Methyl-11-aza-10-deoxo-10-dihydroerythromycin A, CP-62993
• Empirische Formel (Hill-System): C₃₈H₇₂N₂O₁₂ · 2H₂O
• CAS-Nummer: 117772-70-0
• Molekulargewicht: 785.02
• MDL-Nummer: MFCD01862248
• UNSPSC-Code: 41116107
• PubChem Substanz-ID: 329823110
• NACRES: NA.24

Eigenschaften

• Qualität: certified reference material; pharmaceutical secondary standard
• Qualitätsniveau: 300
• 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

Beschreibung

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.

Sicherheitshinweise

• Lagerklassenschlüssel: 11 - Combustible Solids
• WGK: WGK 3
• Flammpunkt (°F): Not applicable
• Flammpunkt (°C): Not applicable