Simvastatin EP Impurity H

Name: Simvastatin EP Impurity H
Brand: Vaqora Chemicals
SKU: VQ-023758

About Simvastatin EP Impurity H

Listed under CAS 79952-42-4, Simvastatin EP Impurity H is a pharmacopeial impurity of Simvastatin available from Vaqora Chemicals. Its molecular formula is C19H28O4 and its molecular weight is 320.4 g/mol. Alternative names: Lovastatin Lactone Diol and Simvastatin - Impurity H.

It is supplied as a solid. Store the standard in its sealed vial, protected from light and moisture, and follow the storage condition printed on the COA. Under GHS it is labelled “Warning”, so handle it with suitable PPE and consult the SDS.

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. It is used across pharmaceutical manufacturing and academic and industrial research.

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and every batch ships with a Certificate of Analysis (COA) and we export 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 H
Catalogue No.	VQ-023758
CAS Number	79952-42-4
IUPAC name	(4R,6R)-6-[2-[(1S,2S,6R,8S,8aR)-8-hydroxy-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]ethyl]-4-hydroxyoxan-2-one
Molecular formula	C₁₉H₂₈O₄
Molecular weight	320.4 g/mol
Exact mass	320.1988
Grade	Reference Standard
HSN code	38229090
InChIKey	ZDFOBOYQVYMVCW-IRUSZSJRSA-N
SMILES	C[C@@H]1C[C@@H]([C@@H]2[C@H]([C@H](C=CC2=C1)C)CC[C@@H]3C[C@H](CC(=O)O3)O)O
PubChem CID	9905162

Physical properties
Physical form	Solid
LogP (XLogP3)	2.3
H-bond donors / acceptors	2 / 4
TPSA	66.8 Å²
Synonyms	Lovastatin Lactone Diol, Simvastatin - Impurity H, Monacolin J, Lovastatin Diol Lactone, Antibiotic MB 530A, monakolin j, monacolin J lactone

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 H?

The CAS Registry Number of Simvastatin EP Impurity H is 79952-42-4. It is also known as Lovastatin Lactone Diol, Simvastatin - Impurity H, Monacolin J.

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

Simvastatin EP Impurity H has the molecular formula C19H28O4 and a molecular weight of 320.4 g/mol. Its IUPAC name is (4R,6R)-6-[2-[(1S,2S,6R,8S,8aR)-8-hydroxy-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]ethyl]-4-hydroxyoxan-2-one.

What is Simvastatin EP Impurity H used for?

Simvastatin EP Impurity H 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 H can I order?

We supply Simvastatin EP Impurity H 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 H?

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

Yes. Simvastatin EP Impurity H 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.