PHR8516
N-亚硝基阿奇霉素
certified reference material, pharmaceutical secondary standard
别名:
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-(((2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-2-ethyl-3,4,10-trihydroxy-13-(((2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy)-3,5,8,10,12,14-hexamethyl-6-nitroso-1-oxa-6-azacyclopentadecan-15-one, N-Nitroso Azithromycin EP Impurity A
grade
certified reference material, pharmaceutical secondary standard
agency
(Not traceable to any primary pharmacopeia standard)
API family
azithromycin
CofA
current certificate can be downloaded
packaging
pkg of 50 mg
manufacturer/tradename
Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
application(s)
pharmaceutical
storage temp.
-10 to -25°C
Quality Level
General description
Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards.
Application
N-Nitroso Azithromycin may be used as a pharmaceutical reference standard for the determination of impurities in pharmaceutical formulations by 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.
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.
Analysis Note
These secondary standards offer multi-traceability to the USP and EP 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.
signalword
Danger
hcodes
Hazard Classifications
Aquatic Chronic 1 - Resp. Sens. 1 - Skin Sens. 1
存储类别
11 - Combustible Solids
法规信息
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