Impurity reference standards
Rosuvastatin impurity standards
For Rosuvastatin, the Zemixal catalogue holds 94 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 19 pharmacopoeial impurities, 1 isotope-labelled standard, 15 metabolites or hydroxylated analogues and 3 degradation products.
94reference materials
19pharmacopoeial
1isotope labelled
15metabolites
Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.
By impurity type
Pharmacopoeial19EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites15Hydroxy, desmethyl and conjugated forms
Degradants3N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Rosuvastatin reference materials
1–60 of 94 standards
(3R,5S)-5-((R)-8-Fluoro-4-isopropyl-2-(N-methylmethylsulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5-dihydroxypentanoic acid
- CAS
- 854898-48-9
- Formula
- C22H28FN3O6S
- MW
- 481.5 g/mol
ZX-026823
(3R,5S)-6-Chloro-3,5-dihydroxyhexanoic Acid tert-Butyl Ester
- CAS
- 154026-93-4
- Formula
- C10H19ClO4
- MW
- 238.71 g/mol
ZX-022699
(3S,5S)-tert-Butyl 6-chloro-3,5-dihydroxyhexanoate
- CAS
- 325471-28-1
- Formula
- C10H19ClO4
- MW
- 238.71 g/mol
ZX-022710
(3S)-4-Chloro-3-[(trimethylsilyl)oxy]butanenitrile
- CAS
- 727382-14-1
- Formula
- C7H14ClNOSi
- MW
- 191.73 g/mol
ZX-022371
(4R,6R)-6-Hydroxymethyl-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,1-Dimethylethyl Ester
- CAS
- 407577-54-2
- Formula
- C13H24O5
- MW
- 260.33 g/mol
ZX-022702
(4R,6S)-6-(Chloromethyl)-4- hydroxytetrahydro-2H-pyran-2-one
- CAS
- 391218-14-7
- Formula
- C6H9ClO3
- MW
- 164.59 g/mol
ZX-032307
(4R,6S)-6-Hydroxymethyl-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,1-Dimethylethyl Ester
- CAS
- 124655-09-0
- Formula
- C13H24O5
- MW
- 260.33 g/mol
ZX-022701
(4S,6R)-6-Hydroxymethyl-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,1-Dimethylethyl Ester
- CAS
- 148809-28-3
- Formula
- C13H24O5
- MW
- 260.33 g/mol
ZX-026075
2-((4R,6S)-2,2-Dimethyl-6-(((1-phenyl-1H-tetrazol-5-yl)sulfonyl)methyl)-1,3-dioxan-4-yl)-N-methoxy-N-methylacetamide
- CAS
- 1353637-12-3
- Formula
- C18H25N5O6S
- MW
- 439.5 g/mol
ZX-045926
4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinecarboxylic acid
- CAS
- 1263475-93-9
- Formula
- C16H18FN3O4S
- MW
- 367.4 g/mol
ZX-026814
6-(4-Fluorophenyl)-1,4-dihydro-4-(1-methylethyl)-2-(methylthio)-5-pyrimidinecarboxylic acid methyl ester
- CAS
- 885100-76-5
- Formula
- C16H19FN2O2S
- MW
- 322.4 g/mol
ZX-042460
Methyl 4-(4-Fluorophenyl)-6-isopropyl-2-(methylamino)pyrimidine-5-carboxylate
- CAS
- 160009-36-9
- Formula
- C16H18FN3O2
- MW
- 303.33 g/mol
ZX-032312
Methyl 4-(4-Fluorophenyl)-6-isopropyl-2-(methylsulfonyl)pyrimidine-5-carboxylate
- CAS
- 799842-06-1
- Formula
- C16H17FN2O4S
- MW
- 352.4 g/mol
ZX-032299
Methyl 4-(4-Fluorophenyl)-6-isopropyl-2-[N-methyl-N-(methylsulfonyl)amino]pyrimidine-5-carboxylate
- CAS
- 289042-11-1
- Formula
- C17H20FN3O4S
- MW
- 381.4 g/mol
ZX-032300
Methyl 4-(4-fluorophenyl)-6-isopropyl-2-oxo-1,2-dihydropyrimidine-5-carboxylate
- CAS
- 488798-37-4
- Formula
- C15H15FN2O3
- MW
- 290.29 g/mol
ZX-026825
Methyl(3r)-3-(tert-butyldimethylsilyloxy)-5-oxo-6-triphenylphosphoranylidene hexanoate
- CAS
- 147118-35-2
- Formula
- C31H39O4PSi
- MW
- 534.7 g/mol
ZX-026821
N-(4-(4-Fluorophenyl)-5-(hydroxymethyl)-6-isopropylpyrimidin-2-yl)methanesulfonamide
- CAS
- 371775-71-2
- Formula
- C15H18FN3O3S
- MW
- 339.4 g/mol
ZX-026826
N-(5-((Diphenylphosphoryl)methyl)-4-(4-fluorophenyl)-6-isopropylpyrimidin-2-yl)-N-methylmethanesulfonamide
- CAS
- 289042-10-0
- Formula
- C28H29FN3O3PS
- MW
- 537.6 g/mol
ZX-026813
N-[4-(4-Fluorophenyl)-5-methyl-6-(1-methylethyl)-2-pyrimidinyl]-N-methylmethanesulfonamide
- CAS
- 953776-62-0
- Formula
- C16H20FN3O2S
- MW
- 337.4 g/mol
ZX-032303
N-[5-Dimethoxymethyl-4-(4-fluorophenyl)-6-isopropyl-pyrimidin-2-yl]-N-methyl methanesulfonamide
- CAS
- 1621283-83-7
- Formula
- C18H24FN3O4S
- MW
- 397.46 g/mol
ZX-042461
Rosuvastatin EP Impurity A(Calcium Salt)
- CAS
- 1714147-47-3
- Formula
- C50H66CaF2N6O14S2
- MW
- 1117.3 g/mol
ZX-005975
Questions
Rosuvastatin impurities, answered
What Rosuvastatin reference materials are available?
The catalogue currently lists 94 compounds for Rosuvastatin, including 19 pharmacopoeial impurities, 1 isotope-labelled standard, 15 metabolites or hydroxylated analogues and 3 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Rosuvastatin impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Rosuvastatin impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.
Are isotope-labelled Rosuvastatin standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.