Atorvastatin EP Impurity M

Name: Atorvastatin EP Impurity M
Brand: Vaqora Chemicals
SKU: VQ-006258

About Atorvastatin EP Impurity M

Atorvastatin EP Impurity M (CAS 1146977-93-6) is a pharmacopeial impurity of Atorvastatin offered by Vaqora Chemicals with a typical assay of 97%. Formula C35H39FN2O5, molecular weight 586.7 g/mol. Alternative names: Atorvastatin Ethyl Ester and Atorvastatin ethyl ester (USP).

The product is provided as a solid. Store the standard in its sealed vial, protected from light and moisture, and follow the storage condition printed on the COA. The GHS classification uses the signal word “Danger”, so appropriate gloves, eye protection and ventilation are recommended.

This Atorvastatin impurity supports analytical method development and validation (AMV), batch release testing and the impurity sections of ANDA and DMF filings. Our customers for this product work in pharmaceutical manufacturing and academic and industrial research.

We offer Atorvastatin EP Impurity M in 10 mg, 25 mg, 50 mg and 100 mg packs with a batch-specific COA, and ship to customers worldwide. This item is currently in stock for prompt dispatch.

Typical applications

Pharmacopeial method verification
Impurity profiling
QC release testing
ANDA / DMF filings

Industries

Related to Atorvastatin

View every impurity, metabolite and intermediate we list for Atorvastatin.

Atorvastatin impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Atorvastatin EP Impurity M
Catalogue No.	VQ-006258
CAS Number	1146977-93-6
IUPAC name	ethyl (3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoate
Molecular formula	C₃₅H₃₉FN₂O₅
Molecular weight	586.7 g/mol
Exact mass	586.2843
Grade	Reference Standard
Purity / assay	97%
HSN code	38229090
InChIKey	CXXBPVDOSCOVJU-FQLXRVMXSA-N
SMILES	CCOC(=O)C[C@@H](C[C@@H](CCN1C(=C(C(=C1C(C)C)C(=O)NC2=CC=CC=C2)C3=CC=CC=C3)C4=CC=C(C=C4)F)O)O
PubChem CID	57892870

Physical properties
Physical form	Solid
LogP (XLogP3)	5.7
H-bond donors / acceptors	3 / 6
TPSA	101 Å²

Safety & hazard information (GHS)

Health hazard

Signal word: Danger

Hazard statements

H319Causes serious eye irritation
H360May damage fertility or the unborn child

Precautionary statements: P203, P264 + P265, P280, P305 + P351 + P338, P318, P337 + P317, P405, P501

Classification is indicative (aggregated GHS notifications) and may vary by grade and concentration. Always refer to the SDS supplied with your lot.

Documents

Safety Data Sheet (SDS)16-section GHS · on request Certificate of AnalysisTypical / batch COA · on request Specification sheetTDS / MOA · on request

Frequently asked questions

What is the CAS number of Atorvastatin EP Impurity M?

The CAS Registry Number of Atorvastatin EP Impurity M is 1146977-93-6. It is also known as Atorvastatin Ethyl Ester, Atorvastatin ethyl ester (USP), Atorvastatin ethyl ester impurity.

What is the molecular formula and molecular weight of Atorvastatin EP Impurity M?

Atorvastatin EP Impurity M has the molecular formula C35H39FN2O5 and a molecular weight of 586.7 g/mol. Its IUPAC name is ethyl (3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoate.

What is Atorvastatin EP Impurity M used for?

Atorvastatin EP Impurity M is supplied as a characterised reference material related to Atorvastatin. It is used for analytical method development and validation (AMV), impurity profiling, stability studies and quality control, and in ANDA/DMF regulatory filings.

Which grade and pack sizes of Atorvastatin EP Impurity M can I order?

We supply Atorvastatin EP Impurity M in Reference Standard (97%) grade, in 10 mg, 25 mg, 50 mg, 100 mg, 250 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Atorvastatin EP Impurity M?

Yes. Every lot of Atorvastatin EP Impurity M is shipped with a batch-specific Certificate of Analysis, and a 16-section GHS Safety Data Sheet is provided with the quotation and the shipment.

Can Atorvastatin EP Impurity M be shipped internationally?

Yes. Atorvastatin EP Impurity M is classified as hazardous, so it is packed in UN-approved packaging and shipped as dangerous goods under IATA/IMDG rules. We export worldwide on EXW, FOB, CIF and DAP terms.