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Pharmacopeial Impurities (EP / USP / BP)

Atorvastatin EP Impurity M

Reference StandardIn stock

Buy Atorvastatin EP Impurity M (CAS 1146977-93-6) from Zemixal. Lab and bulk packs, batch COA, fast global delivery. Catalogue no. ZX-005596.

Pack sizes
Atorvastatin EP Impurity M chemical structure
CAS number1146977-93-6
FormulaC35H39FN2O5
Molar mass586.7 g/mol
Physical formSolid
HS code38229090
Purity97%
InChIKeyCXXBPVDOSCOVJU-FQLXRVMXSA-N
IUPAC nameethyl (3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoate

About Atorvastatin EP Impurity M

Atorvastatin EP Impurity M belongs to the Atorvastatin reference-standard family in the Zemixal catalogue. For your records (Reference Standard), the material is defined by CAS 1146977-93-6, formula C35H39FN2O5 and molar mass 586.7 g/mol. It is handled as a solid.

Typical applications

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

Storage and safety notes

Classified under GHS with signal word Danger and hazard statements H319 and H360. Read the SDS before first use.

Order it in 10 mg, 25 mg, 50 mg, 100 mg and 250 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 M
Product nameAtorvastatin EP Impurity M
Catalogue numberZX-005596
CAS number1146977-93-6
IUPAC nameethyl (3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoate
Molecular formulaC35H39FN2O5
Molar mass586.7 g/mol
Exact mass586.2843
GradeReference Standard
Purity / assay97%
Physical formSolid
XLogP35.7
H-bond donors / acceptors3 / 6
Topological polar surface area101 Ų
HS code38229090
InChIKeyCXXBPVDOSCOVJU-FQLXRVMXSA-N
SMILESCCOC(=O)C[C@@H](C[C@@H](CCN1C(=C(C(=C1C(C)C)C(=O)NC2=CC=CC=C2)C3=CC=CC=C3)C4=CC=C(C=C4)F)O)O
PubChem CID57892870
SynonymsAtorvastatin Ethyl Ester, Atorvastatin ethyl ester (USP), Atorvastatin ethyl ester impurity

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

Safety and GHS hazards

GHS08 Health hazard
Health hazard

Signal word Danger

  • H319Causes serious eye irritation
  • H360May damage fertility or the unborn child

Precautionary statements P203, P264 + P265, P280, P305 + P351 + P338, P318, P337 + P317, P405, 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 M
10 mgQuoted on request
25 mgQuoted on request
50 mgQuoted on request
100 mgQuoted on request
250 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 M

Which CAS number identifies Atorvastatin EP Impurity M?
Atorvastatin EP Impurity M is registered under CAS 1146977-93-6. You may also see it listed as Atorvastatin Ethyl Ester, Atorvastatin ethyl ester (USP), Atorvastatin ethyl ester impurity. Our catalogue number for this item is ZX-005596.
What are the formula and molar mass of Atorvastatin EP Impurity M?
For Atorvastatin EP Impurity M, its formula is C35H39FN2O5 and its molar mass is 586.7 g/mol. The systematic (IUPAC) name is ethyl (3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoate. InChIKey CXXBPVDOSCOVJU-FQLXRVMXSA-N lets you match it in any structure database.
How is Atorvastatin EP Impurity M used in pharmaceutical QC?
Atorvastatin EP Impurity M 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 M?
This listing is Reference Standard grade with 97% purity. Standard packs are 10 mg, 25 mg, 50 mg, 100 mg, 250 mg. Larger quantities and custom packing can be quoted on request.
Which documents come with Atorvastatin EP Impurity M?
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 M to my country?
Yes. Because Atorvastatin EP Impurity M 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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