Simvastatin EP Impurity M

Name: Simvastatin EP Impurity M
Brand: Vaqora Chemicals
SKU: VQ-028037

About Simvastatin EP Impurity M

Simvastatin EP Impurity M is a pharmacopeial impurity of Simvastatin carrying the CAS registry number 864357-87-9. With the molecular formula C27H44O6, it has a molar mass of 464.6 g/mol. Common synonyms include Simvastatin Acid Ethyl Ester and Simvastatin - Impurity M.

It is supplied as a solid. Keep the vial tightly closed, protected from light and humidity, at the temperature stated on the Certificate of Analysis. Good laboratory practice and suitable PPE are recommended during handling.

Pharmaceutical QC and development laboratories use this impurity standard of Simvastatin to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. It is used across pharmaceutical manufacturing and academic and industrial research.

Vaqora Chemicals supplies Simvastatin EP Impurity M in 10 mg, 25 mg, 50 mg and 100 mg packs, each shipped with a Certificate of Analysis (COA), and exports worldwide.

Typical applications

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

Industries

Related to Simvastatin

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

Simvastatin impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Simvastatin EP Impurity M
Catalogue No.	VQ-028037
CAS Number	864357-87-9
IUPAC name	ethyl (3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-(2,2-dimethylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate
Molecular formula	C₂₇H₄₄O₆
Molecular weight	464.6 g/mol
Exact mass	464.3138
Grade	Reference Standard
HSN code	38229090
InChIKey	VVAUQJHCHXQKFR-MLKWKJRISA-N
SMILES	CCC(C)(C)C(=O)O[C@H]1C[C@H](C=C2[C@H]1[C@H]([C@H](C=C2)C)CC[C@H](C[C@H](CC(=O)OCC)O)O)C
PubChem CID	71752200

Physical properties
Physical form	Solid
LogP (XLogP3)	4.6
H-bond donors / acceptors	2 / 6
TPSA	93.1 Å²

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 Simvastatin EP Impurity M?

The CAS Registry Number of Simvastatin EP Impurity M is 864357-87-9. It is also known as Simvastatin Acid Ethyl Ester, Simvastatin - Impurity M, Simvastatin Hydroxy Acid Ethyl Ester.

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

Simvastatin EP Impurity M has the molecular formula C27H44O6 and a molecular weight of 464.6 g/mol. Its IUPAC name is ethyl (3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-(2,2-dimethylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate.

What is Simvastatin EP Impurity M used for?

Simvastatin EP Impurity M is supplied as a characterised reference material related to Simvastatin. 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 Simvastatin EP Impurity M can I order?

We supply Simvastatin EP Impurity M in Reference Standard grade, in 10 mg, 25 mg, 50 mg, 100 mg packs. Larger bulk quantities and custom packing are quoted on request.

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

Yes. Every lot of Simvastatin 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 Simvastatin EP Impurity M be shipped internationally?

Yes. We export Simvastatin EP Impurity M worldwide by air and sea freight or express courier, on EXW, FOB, CIF, CFR or DAP Incoterms, with full export documentation.