Simvastatin EP Impurity B

Name: Simvastatin EP Impurity B
Brand: Vaqora Chemicals
SKU: VQ-028033

About Simvastatin EP Impurity B

Simvastatin EP Impurity B (CAS 145576-25-6) is a pharmacopeial impurity of Simvastatin offered by Vaqora Chemicals. The compound has the formula C27H40O6, corresponding to a molecular weight of 460.6 g/mol. Alternative names: Simvastatin - Impurity B and Acetyl simvastatin.

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. The GHS classification uses the signal word “Warning”, so appropriate gloves, eye protection and ventilation are recommended.

As a characterised impurity of Simvastatin, it is used for analytical method development, method validation (AMV) and routine quality-control testing, and it supports ANDA and DMF regulatory filings. Buyers come mainly from pharmaceutical manufacturing and academic and industrial research.

Available in 10 mg, 25 mg, 50 mg and 100 mg packs, Simvastatin EP Impurity B is dispatched with a Certificate of Analysis (COA) to destinations 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 B
Catalogue No.	VQ-028033
CAS Number	145576-25-6
IUPAC name	[(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-acetyloxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] 2,2-dimethylbutanoate
Molecular formula	C₂₇H₄₀O₆
Molecular weight	460.6 g/mol
Exact mass	460.2825
Grade	Reference Standard
HSN code	38229090
InChIKey	OHVWRJDVJRNCPE-BIKFJBPRSA-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]3C[C@H](CC(=O)O3)OC(=O)C)C
PubChem CID	11812557

Physical properties
Physical form	Solid
LogP (XLogP3)	5.3
H-bond donors / acceptors	0 / 6
TPSA	78.9 Å²
Synonyms	Simvastatin - Impurity B, Acetyl simvastatin, Simvastatin Acetate, Simvastatin acetate ester, 4'-Acetylsimvastatin, Simvastatin specified impurity B, 4'-Acetyl Simvastatin, 4-Acetylsimvastatin

Safety & hazard information (GHS)

Harmful / irritant

Health hazard

Signal word: Warning

Hazard statements

H302Harmful if swallowed

Precautionary statements: P203, P264, P270, P280, P301 + P317, P318, P330, 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 Simvastatin EP Impurity B?

The CAS Registry Number of Simvastatin EP Impurity B is 145576-25-6. It is also known as Simvastatin - Impurity B, Acetyl simvastatin, Simvastatin Acetate.

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

Simvastatin EP Impurity B has the molecular formula C27H40O6 and a molecular weight of 460.6 g/mol. Its IUPAC name is [(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-acetyloxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] 2,2-dimethylbutanoate.

What is Simvastatin EP Impurity B used for?

Simvastatin EP Impurity B 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 B can I order?

We supply Simvastatin EP Impurity B 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 B?

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

Yes. Simvastatin EP Impurity B 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.