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
PHR1422
Atorvastatin Calcium
Pharmaceutical Secondary Standard; Certified Reference Material
Synonym(s):
Atorvastatin hemicalcium salt sesquihydrate, 1H-Pyrrole-1-heptanoic acid, [R-(R*,R*)]-2-(4-flurophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl], calcium salt (2:1)
About This Item
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grade
certified reference material
pharmaceutical secondary standard
Quality Level
Agency
traceable to Ph. Eur. Y0001327
traceable to USP 1044516
API family
atorvastatin
CofA
current certificate can be downloaded
technique(s)
HPLC: suitable
gas chromatography (GC): suitable
application(s)
pharmaceutical (small molecule)
format
neat
storage temp.
2-30°C
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
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This Item | BP1267 | Y0002315 | PHR1872 |
|---|---|---|---|
| technique(s) HPLC: suitable, gas chromatography (GC): suitable | technique(s) - | technique(s) - | technique(s) - |
| format neat | format neat | format - | format neat |
| Quality Level 300 | Quality Level - | Quality Level - | Quality Level 300 |
| grade certified reference material, pharmaceutical secondary standard | grade pharmaceutical primary standard | grade pharmaceutical primary standard | grade certified reference material, pharmaceutical secondary standard |
| storage temp. 2-30°C | storage temp. 2-8°C | storage temp. 2-8°C | storage temp. 2-8°C |
| agency traceable to Ph. Eur. Y0001327 | agency - | agency - | agency traceable to Ph. Eur. Y0001332, traceable to USP 1044571 |
General description
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
Analysis Note
Other Notes
Analyte
comparable product
related product
Signal Word
Danger
Hazard Statements
Precautionary 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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Chromatograms
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How can I determine the shelf life / expiration / retest date of this product?
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How is shipping temperature determined? And how is it related to the product storage temperature?
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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
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I have made a stock solitution in DMSO. At what temperature should I store it and what is the shelf life?
1 answer-
The stability of this product in DMSO has not been determined. However, various sources recommend storing stock solutions in DMSO at -20°C for 1 month and at -80°C for 1 year. As a general rule, avoid repeated freeze/thaw cycles. This information has not been validated.
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Buenos días, como debe reconstituirse el producto: Atorvastatin Calcium, PHR1422? Muchas gracias, Aina
1 answer-
The following solubility characteristics are given in the monograph of the European Pharmacopoeia: practically insoluble in water, very slightly soluble to very soluble in ethanol (96 percent), freely soluble to very soluble in methanol, practically insoluble to freely soluble in methylene chloride, and freely soluble in dimethyl sulfoxide.
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