Simvastatin EP Impurity A (Sodium salt)

Name: Simvastatin EP Impurity A (Sodium salt)
Brand: Vaqora Chemicals
SKU: VQ-028032

About Simvastatin EP Impurity A (Sodium salt)

Simvastatin EP Impurity A (Sodium salt) is a pharmacopeial impurity of Simvastatin carrying the CAS registry number 101314-97-0. With the molecular formula C25H39NaO6, it has a molar mass of 458.6 g/mol. Alternative names: Simvastatin EP Impurity A and Simvastatin - Impurity A (Sodium Salt).

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. Under GHS it is labelled “Warning”, so handle it with suitable PPE and consult the SDS.

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. Typical end-use sectors are pharmaceutical manufacturing and academic and industrial research.

Vaqora Chemicals supplies Simvastatin EP Impurity A (Sodium salt) 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 A (Sodium salt)
Catalogue No.	VQ-028032
CAS Number	101314-97-0
IUPAC name	sodium (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	C₂₅H₃₉NaO₆
Molecular weight	458.6 g/mol
Exact mass	458.2644
Grade	Reference Standard
HSN code	38229090
InChIKey	RLWRROYWKHUVKF-OKDJMAGBSA-M
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)[O-])O)O)C.[Na+]
PubChem CID	16760655

Physical properties
Physical form	Solid
H-bond donors / acceptors	2 / 6
TPSA	107 Å²
Synonyms	Simvastatin EP Impurity A, Simvastatin - Impurity A (Sodium Salt), Tenivastatin sodium, Simvastatin, Sodium Salt, Simvastatin Hydroxy Acid Sodium Salt, simvastatin sodium, Simvastatin hydroxy acid (sodium), Simvastatin (sodium), Simvastatin Na, Simvastatin hydroxy acid sodium, Simvastatin Impurity as Sodium Salt

Safety & hazard information (GHS)

Harmful / irritant

Signal word: Warning

Hazard statements

H302Harmful if swallowed

Precautionary statements: P264, P270, P301 + P317, P330, 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 Simvastatin EP Impurity A (Sodium salt)?

The CAS Registry Number of Simvastatin EP Impurity A (Sodium salt) is 101314-97-0. It is also known as Simvastatin EP Impurity A, Simvastatin - Impurity A (Sodium Salt), Tenivastatin sodium.

What is the molecular formula and molecular weight of Simvastatin EP Impurity A (Sodium salt)?

Simvastatin EP Impurity A (Sodium salt) has the molecular formula C25H39NaO6 and a molecular weight of 458.6 g/mol. Its IUPAC name is sodium (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 A (Sodium salt) used for?

Simvastatin EP Impurity A (Sodium salt) 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 A (Sodium salt) can I order?

We supply Simvastatin EP Impurity A (Sodium salt) 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 A (Sodium salt)?

Yes. Every lot of Simvastatin EP Impurity A (Sodium salt) 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 A (Sodium salt) be shipped internationally?

Yes. Simvastatin EP Impurity A (Sodium salt) 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.