Atorvastatin EP Impurity I

Name: Atorvastatin EP Impurity I
Brand: Vaqora Chemicals
SKU: VQ-020854

About Atorvastatin EP Impurity I

Atorvastatin EP Impurity I (CAS 125971-95-1) is a pharmacopeial impurity of Atorvastatin offered by Vaqora Chemicals. The compound has the formula C40H47FN2O5, corresponding to a molecular weight of 654.8 g/mol. Alternative names: Atorvastatin Calcium EP impurity I and Atorvastatin Acid - Impurity I.

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. It carries the GHS signal word “Warning” with 1 hazard statement. Review the Safety Data Sheet before use.

Pharmaceutical QC and development laboratories use this impurity standard of Atorvastatin 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.

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 Atorvastatin

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

Atorvastatin impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Atorvastatin EP Impurity I
Catalogue No.	VQ-020854
CAS Number	125971-95-1
IUPAC name	tert-butyl 2-[(4R,6R)-6-[2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxan-4-yl]acetate
Molecular formula	C₄₀H₄₇FN₂O₅
Molecular weight	654.8 g/mol
Exact mass	654.3469
Grade	Reference Standard
HSN code	38229090
InChIKey	NPPZOMYSGNZDKY-ROJLCIKYSA-N
SMILES	CC(C)C1=C(C(=C(N1CC[C@@H]2C[C@@H](OC(O2)(C)C)CC(=O)OC(C)(C)C)C3=CC=C(C=C3)F)C4=CC=CC=C4)C(=O)NC5=CC=CC=C5
PubChem CID	10168503

Physical properties
Physical form	Solid
LogP (XLogP3)	7.8
H-bond donors / acceptors	1 / 6
TPSA	78.8 Å²
Synonyms	Atorvastatin Calcium EP impurity I, Atorvastatin Acid - Impurity I, Atorvastatin Related Compound I, Atorvastatin Acetonide tert-Butyl Ester, tert-Butyl atorvastatin acetonide, (4R,6R)-

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 Atorvastatin EP Impurity I?

The CAS Registry Number of Atorvastatin EP Impurity I is 125971-95-1. It is also known as Atorvastatin Calcium EP impurity I, Atorvastatin Acid - Impurity I, Atorvastatin Related Compound I.

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

Atorvastatin EP Impurity I has the molecular formula C40H47FN2O5 and a molecular weight of 654.8 g/mol. Its IUPAC name is tert-butyl 2-[(4R,6R)-6-[2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxan-4-yl]acetate.

What is Atorvastatin EP Impurity I used for?

Atorvastatin EP Impurity I 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 I can I order?

We supply Atorvastatin EP Impurity I 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 Atorvastatin EP Impurity I?

Yes. Every lot of Atorvastatin EP Impurity I 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 I be shipped internationally?

Yes. Atorvastatin EP Impurity I 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.