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Pharmacopeial Impurities (EP / USP / BP)

Simvastatin EP Impurity H

Reference StandardAvailable on request

Order Simvastatin EP Impurity H (CAS 79952-42-4) online at Zemixal. Request a quote with price, lead time and documents.

Pack sizes
Simvastatin EP Impurity H chemical structure
CAS number79952-42-4
FormulaC19H28O4
Molar mass320.4 g/mol
Physical formSolid
HS code38229090
InChIKeyZDFOBOYQVYMVCW-IRUSZSJRSA-N
IUPAC name(4R,6R)-6-[2-[(1S,2S,6R,8S,8aR)-8-hydroxy-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]ethyl]-4-hydroxyoxan-2-one

About Simvastatin EP Impurity H

Simvastatin EP Impurity H is supplied by Zemixal as a characterised reference material for Simvastatin analysis. Key data (Reference Standard): CAS 79952-42-4, formula C19H28O4 and molar mass 320.4 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

Safe handling

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. Add it to your quote list and our team replies with price, lead time and shipping options within one business day.

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 H
Product nameSimvastatin EP Impurity H
Catalogue numberZX-022774
CAS number79952-42-4
IUPAC name(4R,6R)-6-[2-[(1S,2S,6R,8S,8aR)-8-hydroxy-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]ethyl]-4-hydroxyoxan-2-one
Molecular formulaC19H28O4
Molar mass320.4 g/mol
Exact mass320.1988
GradeReference Standard
Physical formSolid
XLogP32.3
H-bond donors / acceptors2 / 4
Topological polar surface area66.8 Ų
HS code38229090
InChIKeyZDFOBOYQVYMVCW-IRUSZSJRSA-N
SMILESC[C@@H]1C[C@@H]([C@@H]2[C@H]([C@H](C=CC2=C1)C)CC[C@@H]3C[C@H](CC(=O)O3)O)O
PubChem CID9905162
SynonymsLovastatin Lactone Diol, Simvastatin - Impurity H, Monacolin J, Lovastatin Diol Lactone, Antibiotic MB 530A, monakolin j, monacolin J lactone

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 Simvastatin EP Impurity H
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 H

Which CAS number identifies Simvastatin EP Impurity H?
Simvastatin EP Impurity H is registered under CAS 79952-42-4. You may also see it listed as Lovastatin Lactone Diol, Simvastatin - Impurity H, Monacolin J. Our catalogue number for this item is ZX-022774.
What are the formula and molar mass of Simvastatin EP Impurity H?
For Simvastatin EP Impurity H, its formula is C19H28O4 and its molar mass is 320.4 g/mol. The systematic (IUPAC) name is (4R,6R)-6-[2-[(1S,2S,6R,8S,8aR)-8-hydroxy-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]ethyl]-4-hydroxyoxan-2-one. InChIKey ZDFOBOYQVYMVCW-IRUSZSJRSA-N lets you match it in any structure database.
How is Simvastatin EP Impurity H used in pharmaceutical QC?
Simvastatin EP Impurity H 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 H?
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 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 Simvastatin EP Impurity H to my country?
Yes. Because Simvastatin EP Impurity H 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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