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Pharmacopeial Impurities (EP / USP / BP)

Simvastatin EP Impurity A (Sodium salt)

Reference StandardAvailable on request

Buy Simvastatin EP Impurity A (Sodium salt) (CAS 101314-97-0) from Zemixal: C25H39NaO6, COA and SDS with every lot, worldwide shipping.

Pack sizes
Simvastatin EP Impurity A (Sodium salt) chemical structure
CAS number101314-97-0
FormulaC25H39NaO6
Molar mass458.6 g/mol
Physical formSolid
HS code38229090
InChIKeyRLWRROYWKHUVKF-OKDJMAGBSA-M
IUPAC namesodium (3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-(2,2-dimethylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate

About Simvastatin EP Impurity A (Sodium salt)

Zemixal lists Simvastatin EP Impurity A (Sodium salt) for laboratories that identify, quantify or control Simvastatin and its related substances. For your records (Reference Standard), the material is defined by CAS 101314-97-0, formula C25H39NaO6 and molar mass 458.6 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

Handling and storage

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

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and custom quantities are quoted on request. Each lot travels with a certificate of analysis with characterisation data. 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

Grade guides

Specifications and identifiers

Specifications of Simvastatin EP Impurity A (Sodium salt)
Product nameSimvastatin EP Impurity A (Sodium salt)
Catalogue numberZX-026936
CAS number101314-97-0
IUPAC namesodium (3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-(2,2-dimethylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate
Molecular formulaC25H39NaO6
Molar mass458.6 g/mol
Exact mass458.2644
GradeReference Standard
Physical formSolid
H-bond donors / acceptors2 / 6
Topological polar surface area107 Ų
HS code38229090
InChIKeyRLWRROYWKHUVKF-OKDJMAGBSA-M
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](C[C@H](CC(=O)[O-])O)O)C.[Na+]
PubChem CID16760655
SynonymsSimvastatin EP Impurity A, Simvastatin - Impurity A (Sodium Salt), Tenivastatin sodium, Simvastatin, Sodium Salt, Simvastatin Hydroxy Acid Sodium Salt, simvastatin sodium, Simvastatin hydroxy acid (sodium), Simvastatin (sodium), Simvastatin Na, Simvastatin hydroxy acid sodium, Simvastatin Impurity as Sodium Salt

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 A (Sodium salt)
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 A (Sodium salt)

Which CAS number identifies Simvastatin EP Impurity A (Sodium salt)?
Simvastatin EP Impurity A (Sodium salt) is registered under CAS 101314-97-0. You may also see it listed as Simvastatin EP Impurity A, Simvastatin - Impurity A (Sodium Salt), Tenivastatin sodium. Our catalogue number for this item is ZX-026936.
What are the formula and molar mass of Simvastatin EP Impurity A (Sodium salt)?
For Simvastatin EP Impurity A (Sodium salt), its formula is C25H39NaO6 and its molar mass is 458.6 g/mol. The systematic (IUPAC) name is sodium (3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-(2,2-dimethylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate. InChIKey RLWRROYWKHUVKF-OKDJMAGBSA-M lets you match it in any structure database.
How is Simvastatin EP Impurity A (Sodium salt) used in pharmaceutical QC?
Simvastatin EP Impurity A (Sodium salt) 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 A (Sodium salt)?
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 A (Sodium salt)?
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 A (Sodium salt) to my country?
Yes. Because Simvastatin EP Impurity A (Sodium salt) 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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