(R)-4-(4-(5-(Aminomethyl)-2-Oxooxazolidin-3-yl)phenyl)Morpholin-3-one Hydrochloride
- CAS
- 1429311-47-6
- Formula
- C14H18ClN3O4
- MW
- 327.76 g/mol
ZX-036130
Impurity reference standards
Rivaroxaban impurity standards
For Rivaroxaban, the Zemixal catalogue holds 97 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 9 pharmacopoeial impurities, 5 nitrosamines, 1 isotope-labelled standard, 6 metabolites or hydroxylated analogues and 3 degradation products.
97reference materials
9pharmacopoeial
5nitrosamines
1isotope labelled
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. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.
By impurity type
Pharmacopoeial9EP, USP, BP or JP named impurities
Nitrosamines5N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites6Hydroxy, 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 Rivaroxaban reference materials
1–60 of 97 standards
(R)-4-(4-(5-(Chloromethyl)-2-oxooxazolidin-3-yl)phenyl)morpholin-3-one
- CAS
- 1252018-28-2
- Formula
- C14H15ClN2O4
- MW
- 310.73 g/mol
ZX-032256
(S)-(3-(5-Chlorothiophene-2-carboxamido)-2-hydroxypropyl)(4-(3-oxomorpholino)phenyl)carbamic acid
- CAS
- 2304798-51-2
- Formula
- C19H20ClN3O6S
- MW
- 453.9 g/mol
ZX-032260
(S)-2-((2-Oxo-3-phenyloxazolidin-5-yl)methyl)isoindoline-1,3-dione
- CAS
- 2137914-93-1
- Formula
- C18H14N2O4
- MW
- 322.3 g/mol
ZX-032251
(S)-4-(4-(5-(Hydroxymethyl)-2-oxooxazolidin-3-yl)phenyl)morpholin-3-one
- CAS
- 2733280-11-8
- Formula
- C14H16N2O5
- MW
- 292.29 g/mol
ZX-032257
(S)-N-((3-(4-Acetamidophenyl)-2-oxooxazolidin-5-yl)methyl)-5-chlorothiophene-2-carboxamide
- CAS
- 2422046-61-3
- Formula
- C17H16ClN3O4S
- MW
- 393.8 g/mol
ZX-026765
2-[(2S)-2,3-Dihydroxypropyl]-1H-isoindole-1,3(2H)-dione
- CAS
- 119835-88-0
- Formula
- C11H11NO4
- MW
- 221.21 g/mol
ZX-032253
2-[2-[[4-[(5S)-5-[[[(5-Chloro-2-thienyl)carbonyl]amino]methyl]-2-oxo-3-oxazolidinyl]phenyl]amino]ethoxy]-acetic Acid Hydrochloride
- CAS
- 931117-61-2
- Formula
- C19H21Cl2N3O6S
- MW
- 490.4 g/mol
ZX-026754
2,2'-((2R,2'R)-((4-(3-Oxomorpholino)phenyl)azanediyl)bis(2-hydroxypropane-3,1-diyl))bis(isoindoline-1,3-dione)
- CAS
- 1643354-27-1
- Formula
- C32H30N4O8
- MW
- 598.6 g/mol
ZX-026766
4-(4-Aminophenyl)-3-morpholinone hydrochloride
- CAS
- 1640884-60-1
- Formula
- C10H12N2O2.ClH
- MW
- 230.67 g/mol
ZX-012118
4-Nitrophenyl 5-chlorothiophene-2-carboxylate
- CAS
- 1450877-56-1
- Formula
- C11H6ClNO4S
- MW
- 283.69 g/mol
ZX-034691
N-Nitroso Rivaroxaban Open-Ring Acid Impurity
- CAS
- 3069765-41-6
- Formula
- C19H19ClN4O7S
- MW
- 482.9 g/mol
ZX-032259
Rac-Rivaroxaban Diphthalimido Morpholinone Analog
- CAS
- 1642600-99-4
- Formula
- C32H30N4O8
- MW
- 598.6 g/mol
ZX-032255
Rivaroxaban Aminomethyl Hydrochloride Impurity
- CAS
- 898543-06-1
- Formula
- C14H18ClN3O4
- MW
- 327.76 g/mol
ZX-005278
Questions
Rivaroxaban impurities, answered
What Rivaroxaban reference materials are available?
The catalogue currently lists 97 compounds for Rivaroxaban, including 9 pharmacopoeial impurities, 5 nitrosamines, 1 isotope-labelled standard, 6 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 Rivaroxaban 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 Rivaroxaban 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.
Do you supply Rivaroxaban nitrosamine impurities?
Yes. 5 N-nitroso compounds are listed for Rivaroxaban. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Rivaroxaban standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.