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Pharmacopeial Impurities (EP / USP / BP)

Atorvastatin EP Impurity H

Reference StandardIn stock

Atorvastatin EP Impurity H (CAS 125995-03-1) supplier Zemixal. Lab and bulk packs, batch COA, fast global delivery. Packs from 10 mg.

Pack sizes
Atorvastatin EP Impurity H chemical structure
CAS number125995-03-1
FormulaC33H33FN2O4
Molar mass540.6 g/mol
Physical formSolid
HS code38229090
InChIKeyOUCSEDFVYPBLLF-KAYWLYCHSA-N
IUPAC name5-(4-fluorophenyl)-1-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-N,4-diphenyl-2-propan-2-ylpyrrole-3-carboxamide

About Atorvastatin EP Impurity H

Analytical teams working on Atorvastatin use Atorvastatin EP Impurity H as a qualified comparison standard. Identity at a glance (Reference Standard): CAS 125995-03-1, formula C33H33FN2O4 and molar mass 540.6 g/mol. It is handled as a solid.

Use cases we see most often

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

Standard pack sizes are 10 mg, 25 mg, 50 mg, 100 mg and 250 mg, and custom quantities are quoted on request. You receive a certificate of analysis with characterisation data with each order. Add it to your quote list and our team replies with price, lead time and shipping options within one business day.

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 H
Product nameAtorvastatin EP Impurity H
Catalogue numberZX-005594
CAS number125995-03-1
IUPAC name5-(4-fluorophenyl)-1-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-N,4-diphenyl-2-propan-2-ylpyrrole-3-carboxamide
Molecular formulaC33H33FN2O4
Molar mass540.6 g/mol
Exact mass540.2424
GradeReference Standard
Physical formSolid
XLogP35.7
H-bond donors / acceptors2 / 5
Topological polar surface area80.6 Ų
HS code38229090
InChIKeyOUCSEDFVYPBLLF-KAYWLYCHSA-N
SMILESCC(C)C1=C(C(=C(N1CC[C@@H]2C[C@H](CC(=O)O2)O)C3=CC=C(C=C3)F)C4=CC=CC=C4)C(=O)NC5=CC=CC=C5
PubChem CID6483036
SynonymsAtorvastatin δ-lactone, Atorvastatin Lactone, Atorvastatin delta-Lactone, Atorvastatin IMpurity H, USP Atorvastatin Related Compound H, Atorvastatin lactone (Standard)

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

Safety and GHS hazards

  • H413May cause long lasting harmful effects to aquatic life

Precautionary statements P273, 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 H
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 H

Which CAS number identifies Atorvastatin EP Impurity H?
Atorvastatin EP Impurity H is registered under CAS 125995-03-1. You may also see it listed as Atorvastatin δ-lactone, Atorvastatin Lactone, Atorvastatin delta-Lactone. Our catalogue number for this item is ZX-005594.
What are the formula and molar mass of Atorvastatin EP Impurity H?
For Atorvastatin EP Impurity H, its formula is C33H33FN2O4 and its molar mass is 540.6 g/mol. The systematic (IUPAC) name is 5-(4-fluorophenyl)-1-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-N,4-diphenyl-2-propan-2-ylpyrrole-3-carboxamide. InChIKey OUCSEDFVYPBLLF-KAYWLYCHSA-N lets you match it in any structure database.
How is Atorvastatin EP Impurity H used in pharmaceutical QC?
Atorvastatin EP Impurity H 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 H?
This listing is Reference Standard grade. 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 H?
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 H to my country?
Yes. Atorvastatin EP Impurity H ships worldwide by express courier, air cargo or sea freight, quoted on the Incoterm you prefer, with full export documents.

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