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重要文件

PHR1088

Supelco

阿齐霉素

Pharmaceutical Secondary Standard; Certified Reference Material

同義詞:

阿齐霉素 二水合物

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About This Item

經驗公式(希爾表示法):
C38H72N2O12 · 2H2O
CAS號碼:
分子量::
785.02
MDL號碼:
分類程式碼代碼:
41116107
PubChem物質ID:
NACRES:
NA.24
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等級

certified reference material
pharmaceutical secondary standard

品質等級

agency

traceable to Ph. Eur. Y0000306
traceable to USP 1046056

API 家族

azithromycin

CofA

current certificate can be downloaded

技術

HPLC: suitable
gas chromatography (GC): suitable

應用

pharmaceutical (small molecule)

形式

neat

儲存溫度

-10 to -25°C

SMILES 字串

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 密鑰

SRMPHJKQVUDLQE-KUJJYQHYSA-N

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一般說明

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.

應用

Azithromycin may be used as a pharmaceutical reference standard for the determination of the analyte in plasma/serum[1][2] samples and pharmaceutical formulations[3] 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.

生化/生理作用

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.

分析報告

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

其他說明

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.

腳註

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.

相關產品

產品號碼
描述
訂價

儲存類別代碼

11 - Combustible Solids

水污染物質分類(WGK)

WGK 3

閃點(°F)

Not applicable

閃點(°C)

Not applicable


分析證明 (COA)

輸入產品批次/批號來搜索 分析證明 (COA)。在產品’s標籤上找到批次和批號,寫有 ‘Lot’或‘Batch’.。

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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)
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)
P M Bartold et al.
Inflammopharmacology, 21(4), 321-338 (2013-03-01)
Macrolide antibiotics have been found to possess not only antimicrobial properties, but also modulate inflammation. In this review the multi-faceted properties of azithromycin are discussed. Due to the unique anti-inflammatory and antimicrobial properties, macrolides, and especially azithromycin, are currently used
Robin Vos et al.
Transplantation, 94(2), 101-109 (2012-03-31)
Chronic lung allograft rejection is the single most important cause of death in lung transplant recipients after the first postoperative year, resulting in a 5-year survival rate of approximately 50%, which is far behind that of other solid organ transplantations.

Questions

1–4 of 4 Questions  
  1. What is the assay purity, active fraction and 1-water content of Azithromycin?

    1 answer
    1. This product is tested against, and is traceable to, the current EP and USP standard. The item is intended for use as an analytical standard. The purity and moisture content are lot specific and reported in the product Certificate of Analysis. A brief review of recent lots indicate a purity of approximately 95% on an 'as is' basis and a moisture content of 4.0 - 4.5%. The active fraction is not determined. Please see the link below to review a sample or lot specific Certificate:
      https://www.sigmaaldrich.com/product/sial/phr1088#product-documentation

      Helpful?

  2. What is the maximum solubility of Azithromycin in DMSO?

    1 answer
    1. This product is soluble in DMSO at approximately 5 mg/mL. Other solvents include ethanol and dimethyl formamide (DMF) at approximately 16 mg/mL.

      Helpful?

  3. What is the solubility of the product AZITHROMYCIN (PHR1088)?

    1 answer
    1. The product is soluble in methanol, DMSO (greater than 20 mg/mL), ethanol, chloroform, and dimethylchloride.

      Helpful?

  4. PHR1088 Supelco Azithromycin How much is the measured water content and active fraction of the product?

    1 answer
    1. This product is listed as a dihydrate. A brief survey of recent lots reveals a general range of 4.1 - 4.4% H2O by Karl Fischer Titration. The water content is a lot specific. Please see the link below to access the Certificate of Analysis for a specific lot:
      https://www.sigmaaldrich.com/search

      Helpful?

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