PHR1870
阿托伐他汀相关化合物 C
Pharmaceutical Secondary Standard; Certified Reference Material
别名:
(βR,δR)-2,3-Bis(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemicalcium salt
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关于此项目
Quality Level
grade
certified reference material, pharmaceutical secondary standard
agency
traceable to Ph. Eur. Y0001330, traceable to USP 1044549
API family
atorvastatin
CofA
current certificate can be downloaded
packaging
pkg of 30 mg
application(s)
pharmaceutical
format
neat
storage temp.
-10 to -25°C
General description
This material is an impurity of atorvastatin. Atorvastatin is a synthetic HMG-CoA reductase inhibitor which lowers plasma cholesterol levels by inhibiting endogenous cholesterol synthesis.
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.
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
Atorvastatin may be used as a pharmaceutical reference standard for the determination of the analyte in drug dosage forms 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.
To see an example of a Certificate of Analysis for this material enter LRAB7553 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.
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存储类别
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
Atorvastatin associated liver disease
Clarke, AT and Mills, PR
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 38(10), 772-777 (2006)
An HPLC method for the determination of atorvastatin and its impurities in bulk drug and tablets
Erturk S, et al.
Journal of Pharmaceutical and Biomedical Analysis, 33(5), 1017-1023 (2003)
HPLC methods for the determination of simvastatin and atorvastatin
Novakova L, et al.
TrAC, Trends in Analytical Chemistry, 27(4), 352-367 (2008)
全球贸易项目编号
| 货号 | GTIN |
|---|---|
| PHR1870-30MG | 04061835220397 |