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Merck
CN

PHR8516

N-Nitroso Azithromycin

certified reference material, pharmaceutical secondary standard

Synonym(s):

(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

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About This Item

Empirical Formula (Hill Notation):
C37H69N3O13
Molecular Weight:
763.96
UNSPSC Code:
12352200
NACRES:
NA.24

Key Documents

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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

300

Related Categories

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.

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.

pictograms

Health hazardEnvironment
GHS08,GHS09

signalword

Danger

Hazard Classifications

Aquatic Chronic 1 - Resp. Sens. 1 - Skin Sens. 1

Storage Class

11 - Combustible Solids

Regulatory Information

新产品
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Certificates of Analysis (COA)

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