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1044516

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
MDL number:
UNSPSC Code:
41116107
NACRES:
NA.24
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grade

pharmaceutical primary standard

API family

atorvastatin

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecule)

format

neat

SMILES string

[Ca+2].Fc5ccc(cc5)c6[n](c(c(c6c8ccccc8)C(=O)Nc7ccccc7)C(C)C)CC[C@@H](O)C[C@@H](O)CC(=O)O.Fc1ccc(cc1)c2[n](c(c(c2c4ccccc4)\C(=N\c3ccccc3)\[O-])C(C)C)CC[C@@H](O)C[C@@H](O)CC(=O)[O-].O.O.O

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

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. [1]

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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manufacturer/tradename

USP

manufacturer/tradename

EDQM

manufacturer/tradename

-

manufacturer/tradename

BP

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

grade

certified reference material, pharmaceutical secondary standard

grade

pharmaceutical primary standard

format

neat

format

-

format

neat

format

neat

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical
pharmaceutical small molecule

API family

atorvastatin

API family

atorvastatin

API family

atorvastatin

API family

atorvastatin


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flash_point_f

Not applicable

flash_point_c

Not applicable

target_organs

Liver

pictograms

Health hazardEnvironment

signalword

Warning

hcodes

Hazard Classifications

Aquatic Chronic 2 - STOT RE 2

Storage Class

11 - Combustible Solids



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Atorvastatin Calcium Tablets
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 42(1), 418-418 (2020)
Atorvastatin and Atorvastatin Tablets
United States Pharmacopeia and National Formulary
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)



Global Trade Item Number

SKUGTIN
1044516-100MG04061838671813

Questions

1–3 of 3 Questions  
  1. How can I determine the shelf life / expiration / retest date of this product?

    1 answer
    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/418/501/product-dating-information-06-25-mk.pdf

      Helpful?

  2. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer
    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

      Helpful?

  3. What does the "calcium" indicate in the prescription drug Atorvastatin?

    1 answer
    1. The term "calcium" indicates that Atorvastatin is in the form of a calcium salt.

      Helpful?

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