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Pharmacopeial Impurities (EP / USP / BP)

Rosuvastatin EP Impurity D

Reference StandardAvailable on request

Rosuvastatin EP Impurity D (CAS 503610-43-3) supplier Zemixal. Lab and bulk packs, batch COA, fast global delivery. Catalogue no. ZX-005979.

Pack sizes
Rosuvastatin EP Impurity D chemical structure
CAS number503610-43-3
FormulaC22H26FN3O5S
Molar mass463.5 g/mol
Physical formSolid
HS code38229090
InChIKeySOEGVMSNJOCVHT-VEUZHWNKSA-N
IUPAC nameN-[4-(4-fluorophenyl)-5-[(E)-2-[(2S,4R)-4-hydroxy-6-oxooxan-2-yl]ethenyl]-6-propan-2-ylpyrimidin-2-yl]-N-methylmethanesulfonamide

About Rosuvastatin EP Impurity D

Rosuvastatin EP Impurity D belongs to the Rosuvastatin reference-standard family in the Zemixal catalogue. Key data (Reference Standard): CAS 503610-43-3, formula C22H26FN3O5S and molar mass 463.5 g/mol. It is handled as a solid.

Typical applications

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

Safe handling

Classified under GHS with signal word Warning and hazard statements H315, H319, H335 and H373. Read the SDS before first use.

Available as 10 mg, 25 mg, 50 mg and 100 mg. Larger or split packs can be arranged. 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 Rosuvastatin

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

Rosuvastatin 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 Rosuvastatin EP Impurity D
Product nameRosuvastatin EP Impurity D
Catalogue numberZX-005979
CAS number503610-43-3
IUPAC nameN-[4-(4-fluorophenyl)-5-[(E)-2-[(2S,4R)-4-hydroxy-6-oxooxan-2-yl]ethenyl]-6-propan-2-ylpyrimidin-2-yl]-N-methylmethanesulfonamide
Molecular formulaC22H26FN3O5S
Molar mass463.5 g/mol
Exact mass463.1577
GradeReference Standard
Physical formSolid
XLogP32.4
H-bond donors / acceptors1 / 9
Topological polar surface area118 Ų
HS code38229090
InChIKeySOEGVMSNJOCVHT-VEUZHWNKSA-N
SMILESCC(C)C1=NC(=NC(=C1/C=C/[C@@H]2C[C@H](CC(=O)O2)O)C3=CC=C(C=C3)F)N(C)S(=O)(=O)C
PubChem CID29918986
SynonymsRosuvastatin lactone, Rosuvastatin-5S-lactone, ent-Rosuvastatin Lactone, Rosuvastatin 5 S-lactone, Rosuvastatin-5-S-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
GHS08 Health hazard
Health hazard

Signal word Warning

  • H315Causes skin irritation
  • H319Causes serious eye irritation
  • H335May cause respiratory irritation
  • H373May causes damage to organs through prolonged or repeated exposure

Precautionary statements P260, P261, P264, P264 + P265, P271, P280, P302 + P352, P304 + P340, P305 + P351 + P338, P319, P321, P332 + P317, P337 + P317, P362 + P364, P403 + P233, 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 Rosuvastatin EP Impurity D
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 Rosuvastatin EP Impurity D

Which CAS number identifies Rosuvastatin EP Impurity D?
Rosuvastatin EP Impurity D is registered under CAS 503610-43-3. You may also see it listed as Rosuvastatin lactone, Rosuvastatin-5S-lactone, ent-Rosuvastatin Lactone. Our catalogue number for this item is ZX-005979.
What are the formula and molar mass of Rosuvastatin EP Impurity D?
For Rosuvastatin EP Impurity D, its formula is C22H26FN3O5S and its molar mass is 463.5 g/mol. The systematic (IUPAC) name is N-[4-(4-fluorophenyl)-5-[(E)-2-[(2S,4R)-4-hydroxy-6-oxooxan-2-yl]ethenyl]-6-propan-2-ylpyrimidin-2-yl]-N-methylmethanesulfonamide. InChIKey SOEGVMSNJOCVHT-VEUZHWNKSA-N lets you match it in any structure database.
How is Rosuvastatin EP Impurity D used in pharmaceutical QC?
Rosuvastatin EP Impurity D is a characterised reference material linked to Rosuvastatin. 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 Rosuvastatin EP Impurity D?
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 Rosuvastatin EP Impurity D?
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 Rosuvastatin EP Impurity D to my country?
Yes. Because Rosuvastatin EP Impurity D 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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