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Pharmacopeial Impurities (EP / USP / BP)

Simvastatin EP Impurity B

Reference StandardAvailable on request

Simvastatin EP Impurity B (CAS 145576-25-6) supplier Zemixal. Lab and bulk packs, batch COA, fast global delivery. Packs from 10 mg.

Pack sizes
Simvastatin EP Impurity B chemical structure
CAS number145576-25-6
FormulaC27H40O6
Molar mass460.6 g/mol
Physical formSolid
HS code38229090
InChIKeyOHVWRJDVJRNCPE-BIKFJBPRSA-N
IUPAC name[(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-acetyloxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] 2,2-dimethylbutanoate

About Simvastatin EP Impurity B

Analytical teams working on Simvastatin use Simvastatin EP Impurity B as a qualified comparison standard. Key data (Reference Standard): CAS 145576-25-6, formula C27H40O6 and molar mass 460.6 g/mol. It is handled as a solid.

Typical applications

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

Handling and storage

Hazard communication follows GHS (Warning: H302). Our SDS lists exposure controls and first-aid measures.

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and custom quantities are quoted on request. Every shipment includes a certificate of analysis with characterisation data. Send an enquiry through the quote panel and you get a formal offer with Incoterms and delivery time.

Reference standards for Simvastatin

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

Simvastatin 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 Simvastatin EP Impurity B
Product nameSimvastatin EP Impurity B
Catalogue numberZX-026937
CAS number145576-25-6
IUPAC name[(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-acetyloxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] 2,2-dimethylbutanoate
Molecular formulaC27H40O6
Molar mass460.6 g/mol
Exact mass460.2825
GradeReference Standard
Physical formSolid
XLogP35.3
H-bond donors / acceptors0 / 6
Topological polar surface area78.9 Ų
HS code38229090
InChIKeyOHVWRJDVJRNCPE-BIKFJBPRSA-N
SMILESCCC(C)(C)C(=O)O[C@H]1C[C@H](C=C2[C@H]1[C@H]([C@H](C=C2)C)CC[C@@H]3C[C@H](CC(=O)O3)OC(=O)C)C
PubChem CID11812557
SynonymsSimvastatin - Impurity B, Acetyl simvastatin, Simvastatin Acetate, Simvastatin acetate ester, 4'-Acetylsimvastatin, Simvastatin specified impurity B, 4'-Acetyl Simvastatin, 4-Acetylsimvastatin

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
GHS08 Health hazard
Health hazard

Signal word Warning

  • H302Harmful if swallowed

Precautionary statements P203, P264, P270, P280, P301 + P317, P318, P330, 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 Simvastatin EP Impurity B
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 Simvastatin EP Impurity B

Which CAS number identifies Simvastatin EP Impurity B?
Simvastatin EP Impurity B is registered under CAS 145576-25-6. You may also see it listed as Simvastatin - Impurity B, Acetyl simvastatin, Simvastatin Acetate. Our catalogue number for this item is ZX-026937.
What are the formula and molar mass of Simvastatin EP Impurity B?
For Simvastatin EP Impurity B, its formula is C27H40O6 and its molar mass is 460.6 g/mol. The systematic (IUPAC) name is [(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-acetyloxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] 2,2-dimethylbutanoate. InChIKey OHVWRJDVJRNCPE-BIKFJBPRSA-N lets you match it in any structure database.
How is Simvastatin EP Impurity B used in pharmaceutical QC?
Simvastatin EP Impurity B is a characterised reference material linked to Simvastatin. 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 Simvastatin EP Impurity B?
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 Simvastatin EP Impurity B?
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 Simvastatin EP Impurity B to my country?
Yes. Because Simvastatin EP Impurity B 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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