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Merck
CN

PHR1874

阿托伐他汀相关化合物 I

pharmaceutical secondary standard, certified reference material

别名:

(4R,6R)-1,3-二氧杂环己烷-4-乙酸 6-[2-[2-(4-氟苯基)-5-(1-甲基乙基)-3-苯基-4-[(苯氨基)羰基]-1H-吡咯-1-基]乙基]-2,2-二甲基-1,1-二甲基乙酯

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经验公式（希尔记法）:
C40H47FN2O5
化学文摘社编号:
125971-95-1
分子量:
654.81
UNSPSC Code:
12352005
NACRES:
NA.24
MDL number:
MFCD04039904

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InChI

1S/C40H47FN2O5/c1-26(2)36-35(38(45)42-30-16-12-9-13-17-30)34(27-14-10-8-11-15-27)37(28-18-20-29(41)21-19-28)43(36)23-22-31-24-32(47-40(6,7)46-31)25-33(44)48-39(3,4)5/h8-21,26,31-32H,22-25H2,1-7H3,(H,42,45)/t31-,32-/m1/s1

SMILES string

CC(C)c1c(C(=O)Nc2ccccc2)c(-c3ccccc3)c(-c4ccc(F)cc4)n1CC[C@@H]5C[C@H](CC(=O)OC(C)(C)C)OC(C)(C)O5

InChI key

NPPZOMYSGNZDKY-ROJLCIKYSA-N

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to USP 1044593

API family

atorvastatin

CofA

current certificate can be downloaded

packaging

pkg of 30 mg

mp

144-148 °C (lit.)

application(s)

pharmaceutical

format

neat

storage temp.

2-8°C

Quality Level

300

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相关类别

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.

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 LRAB1040 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

存储类别

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

分析证书(COA)

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HPLC methods for the determination of simvastatin and atorvastatin
Novakova L, et al.
TrAC, Trends in Analytical Chemistry, 27(4), 352-367 (2008)
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)
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)

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