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Pharmacopeial Impurities (EP / USP / BP)

Atorvastatin EP Impurity I

Reference StandardAvailable on request

Buy Atorvastatin EP Impurity I (CAS 125971-95-1) from Zemixal: C40H47FN2O5, COA and SDS with every lot, worldwide shipping.

Pack sizes
Atorvastatin EP Impurity I chemical structure
CAS number125971-95-1
FormulaC40H47FN2O5
Molar mass654.8 g/mol
Physical formSolid
HS code38229090
InChIKeyNPPZOMYSGNZDKY-ROJLCIKYSA-N
IUPAC nametert-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

About Atorvastatin EP Impurity I

Analytical teams working on Atorvastatin use Atorvastatin EP Impurity I as a qualified comparison standard. Identity at a glance (Reference Standard): CAS 125971-95-1, formula C40H47FN2O5 and molar mass 654.8 g/mol. It is handled as a solid.

Where it is used

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

Storage and safety notes

It carries the GHS signal word Warning (H302), so wear gloves and eye protection and work with good ventilation.

Order it in 10 mg, 25 mg, 50 mg and 100 mg packs or ask for a bulk quotation. You receive a certificate of analysis with characterisation data with each order. Request pricing online and we confirm availability, documentation and freight to your country.

Reference standards for Atorvastatin

See every impurity, metabolite and related compound we list for this API.

Atorvastatin standards

Typical uses

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

Applications

Pharmaceutical Manufacturing and QCResearch Labs and Universities

Grade guides

Ph. Eur. Grade (European Pharmacopoeia)

Specifications and identifiers

Specifications of Atorvastatin EP Impurity I
Product nameAtorvastatin EP Impurity I
Catalogue numberZX-019911
CAS number125971-95-1
IUPAC nametert-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 formulaC40H47FN2O5
Molar mass654.8 g/mol
Exact mass654.3469
GradeReference Standard
Physical formSolid
XLogP37.8
H-bond donors / acceptors1 / 6
Topological polar surface area78.8 Ų
HS code38229090
InChIKeyNPPZOMYSGNZDKY-ROJLCIKYSA-N
SMILESCC(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 CID10168503
SynonymsAtorvastatin Calcium EP impurity I, Atorvastatin Acid - Impurity I, Atorvastatin Related Compound I, Atorvastatin Acetonide tert-Butyl Ester, tert-Butyl atorvastatin acetonide, (4R,6R)-

Lot values are stated on the batch certificate of analysis. Ask for a typical COA with your quotation.

Safety and GHS hazards

GHS07 Irritant or harmful
Irritant or harmful

Signal word Warning

  • H302Harmful if swallowed

Precautionary statements P264, P270, P301 + P317, P330, P501

Classification summarised from public GHS notifications. It can vary with grade and concentration, so always follow the SDS supplied with your lot.

Pack sizes

Pack sizes of Atorvastatin EP Impurity I
10 mgQuoted on request
25 mgQuoted on request
50 mgQuoted on request
100 mgQuoted on request

Need a different size? Bulk drums and custom packing are quoted on request through the quote form on this page.

Questions about Atorvastatin EP Impurity I

Which CAS number identifies Atorvastatin EP Impurity I?
Atorvastatin EP Impurity I is registered under CAS 125971-95-1. You may also see it listed as Atorvastatin Calcium EP impurity I, Atorvastatin Acid - Impurity I, Atorvastatin Related Compound I. Our catalogue number for this item is ZX-019911.
What are the formula and molar mass of Atorvastatin EP Impurity I?
For Atorvastatin EP Impurity I, its formula is C40H47FN2O5 and its molar mass is 654.8 g/mol. The systematic (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. InChIKey NPPZOMYSGNZDKY-ROJLCIKYSA-N lets you match it in any structure database.
How is Atorvastatin EP Impurity I used in pharmaceutical QC?
Atorvastatin EP Impurity I is a characterised reference material linked to Atorvastatin. Laboratories use it to identify and quantify this impurity during method development and validation, stability work, batch release testing and regulatory submissions.
What grade and pack sizes are available for Atorvastatin EP Impurity I?
This listing is Reference Standard grade. Standard packs are 10 mg, 25 mg, 50 mg, 100 mg. Larger quantities and custom packing can be quoted on request.
Which documents come with Atorvastatin EP Impurity I?
Each lot ships with a batch certificate of analysis and a 16-section GHS safety data sheet. A typical COA or specification sheet can be shared with the quotation before you order.
Can Zemixal ship Atorvastatin EP Impurity I to my country?
Yes. Because Atorvastatin EP Impurity I is classed as hazardous, it travels in UN-approved packaging as dangerous goods under IATA or IMDG rules, with the export paperwork your broker needs.

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