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USP

Atorvastatin Calcium

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

Atorvastatin hemicalcium salt sesquihydrate

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About This Item

Empirical Formula (Hill Notation):
C66H68CaF2N4O10 · 3H2O
CAS Number:
Molecular Weight:
1209.39
UNSPSC Code:
41116107
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

atorvastatin

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecule)

format

neat

InChI

1S/2C33H35FN2O5.Ca.3H2O/c2*1-21(2)31-30(33(41)35-25-11-7-4-8-12-25)29(22-9-5-3-6-10-22)32(23-13-15-24(34)16-14-23)36(31)18-17-26(37)19-27(38)20-28(39)40;;;;/h2*3-16,21,26-27,37-38H,17-20H2,1-2H3,(H,35,41)(H,39,40);;3*1H2/q;;+2;;;/p-2/t2*26-,27-;;;;/m11..../s1

InChI key

SHZPNDRIDUBNMH-NIJVSVLQSA-L

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General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Atorvastatin Calcium is a synthetic selective inhibitor of HMG-CoA reductase. It is insoluble in aqueous solution with pH below 4 and is freely soluble in methanol.

Application

Atorvastatin calcium USP reference standard intended for use in specified quality tests and assays.

Also used to prepare system suitability, standard, system suitability stock, identification, and standard stock solution for assay and impurity analysis according to the given below monographs of United States Pharmacopeia (USP):
  • Atorvastatin Calcium
  • Atorvastatin Calcium Tablets
  • Amlodipine and Atorvastatin Tablets

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

Sales restrictions may apply.

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Pricing

Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

Hazard Classifications

Carc. 2 - Repr. 1B

Storage Class Code

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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United States Pharmacopeia, 43(2), 265-265 (2020)
Development and validation of analytical methods for simultaneous estimation of atorvastatin calcium and ezetimibe in combined dosage form.
Rajamanickam, V., et al.
World Applied Sciences Journal , 9.12, 1424-1429 (2010)
Atorvastatin Calcium Tablets
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 42(1), 418-418 (2020)
Atorvastatin Calcium
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 35(1), 414-414 (2022)
Min-Soo Kim et al.
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, 69(2), 454-465 (2008-03-25)
In this work, amorphous atorvastatin calcium nanoparticles were successfully prepared using the supercritical antisolvent (SAS) process. The effect of process variables on particle size and distribution of atorvastatin calcium during particle formation was investigated. Solid state characterization, solubility, intrinsic dissolution

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