Roxithromycin Impurity Standards
Roxithromycin Impurity Standards
Roxithromycin impurity reference standards are used by pharmaceutical quality-control laboratories, contract research organisations, and generic drug manufacturers to identify, quantify, and control Roxithromycin-related impurities during analytical method development, method validation, and regulatory filing. As a macrolide antibiotic, Roxithromycin requires precise characterisation of its process impurities, degradation products, and related substances to meet European Pharmacopoeia (EP), United States Pharmacopeia (USP), and British Pharmacopoeia (BP) monograph requirements. Allmpus Laboratories manufactures and supplies a comprehensive library of Roxithromycin impurity standards, each provided with a Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS). All products are held in-stock for rapid dispatch and are suitable for use in ANDA and DMF regulatory submissions.
ROXITHROMYCIN
Chemical Name: (3R,4S,5S,6R,7R,9R,11S,12R,13S,14R,E)-6-...
CAS No:
80214-83-1
Molecular Formula: C41H76N2O15
Molecular Weight: 837.05
CAT No:
ALL-ROX-STD
Keywords: ROXITHROMYCIN, (9E)-9-[O-[(2-Methoxyetho...
Inventory Status:IN STOCK/09-201
ROXITHROMYCIN EP IMPURITY A
Chemical Name: (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-[(...
CAS No:
114-07-8
Molecular Formula: C37H67NO13
Molecular Weight: 733.93
CAT No:
ALL-ROX-A
Keywords: SMILES string - C[C@@H]([C@@H]([C@H](C(...
Inventory Status:IN STOCK/09-190
ROXITHROMYCIN EP IMPURITY B
Chemical Name: 3-O-De(2,6-Dideoxy-3-C-methyl-3-O-methyl...
CAS No:
214902-82-6
Molecular Formula: C33H62N2O12
Molecular Weight: 678.85
CAT No:
ALL-ROX-2398
Keywords: SMILES string - O=C([C@H](C)[C@@H](O)[C...
Inventory Status:IN STOCK/09-191
ROXITHROMYCIN EP IMPURITY C
Chemical Name: Erythromycin A 9-(E)-oxime
CAS No:
111321-02-9 (9E) | 13127-18-9 (9ZE)
Molecular Formula: C37H68N2O13
Molecular Weight: 748.94
CAT No:
ALL-ROX-C
Keywords: SMILES string - C[C@H]([C@H]([C@](O)(C...
Inventory Status:IN STOCK/09-192
ROXITHROMYCIN EP IMPURITY D
Chemical Name: Erythromycin 9-(Z)-[O-[(2-Methoxyethoxy)...
CAS No:
134931-00-3
Molecular Formula: C41H76N2O15
Molecular Weight: 837.05
CAT No:
ALL-ROX-2400
Keywords: SMILES string - O=C([C@H](C)[C@@H](O[C@...
Inventory Status:IN STOCK/09-193
ROXITHROMYCIN EP IMPURITY E
Chemical Name: 3″-O-Demethylerythromycin-9-(E)-[O-[(2...
CAS No:
1460313-66-9
Molecular Formula: C40H74N2O15
Molecular Weight: 823.02
CAT No:
ALL-ROX-2401
Keywords: SMILES string - O=C([C@H](C)[C@@H](O[C@...
Inventory Status:IN STOCK/09-194
ROXITHROMYCIN EP IMPURITY F
Chemical Name: 3′-N-Demethylerythromycin-9-(E)-[O-[(2...
CAS No:
118267-18-8
Molecular Formula: C40H74N2O15
Molecular Weight: 823.02
CAT No:
ALL-ROX-2402
Keywords: SMILES string - O=C([C@H](C)[C@@H](O[C@...
Inventory Status:IN STOCK/09-195
ROXITHROMYCIN EP IMPURITY G
Chemical Name: Erythromycin 9-(E)-[O-[[(2-Methoxyethoxy...
CAS No:
425365-64-6
Molecular Formula: C42H78N2O16
Molecular Weight: 867.07
CAT No:
ALL-ROX-2403
Keywords: SMILES string - C[C@H]([C@H]([C@](O)(C[...
Inventory Status:IN STOCK/09-196
ROXITHROMYCIN EP IMPURITY H
Chemical Name: (9E)-12-Deoxy-9-[O-[(2-methoxyethoxy)met...
CAS No:
425365-65-7
Molecular Formula: C41H76N2O14
Molecular Weight: 821.05
CAT No:
ALL-ROX-2720
Keywords: SMILES string - O=C([C@H](C)[C@@H](O[C@...
Inventory Status:IN STOCK/09-197
ROXITHROMYCIN EP IMPURITY I
Chemical Name: (3R,4S,5S,6R,7R,9R,11S,12S,13S,14R,E)-6-...
CAS No:
425365-66-8
Molecular Formula: C45H84N2O17
Molecular Weight: 925.15
CAT No:
ALL-ROX-2406
Keywords: SMILES string - O=C(O[C@H](CC)[C@@](C)(...
Inventory Status:IN STOCK/09-200
ROXITHROMYCIN EP IMPURITY J
Chemical Name: Erythromycin 9-(E)-[O-[(2-Chloroethoxy)m...
CAS No:
134834-12-1
Molecular Formula: C40H73ClN2O14
Molecular Weight: 841.17
CAT No:
ALL-ROX-2404
Keywords: SMILES string - O=C(O[C@H](CC)[C@@](C)(...
Inventory Status:IN STOCK/09-198
ROXITHROMYCIN EP IMPURITY K
Chemical Name: Erythromycin 9-(E)-[O-[[2-(Hydroxymethox...
CAS No:
N.A
Molecular Formula: C41H76N2O16
Molecular Weight: 853.05
CAT No:
ALL-ROX-2405
Keywords: SMILES string - OCOCCOCO/N=C([C@H](C)[C...
Inventory Status:IN STOCK/09-199
Key Roxithromycin Impurity Variants Available
- Roxithromycin EP Impurity A (Erythromycin A) — the parent macrolide carried over as a starting-material-related impurity
- Roxithromycin EP Impurity C (Erythromycin A (E) — 9-Oxime / Erythromycin Oxime)-the C-9 oxime intermediate impurity, also referenced as Clarithromycin EP Impurity J
- Roxithromycin EP Impurity D — a process-related impurity listed in the EP related-substances test for Roxithromycin
- Roxithromycin EP Impurity I — an etherified oxime-protected impurity monitored during synthesis and stability testing
- N — Demethylroxithromycin (Roxithromycin Impurity J-related)-a demethylation product monitored as a related substance
Allmpus Capability for the Roxithromycin/Macrolide Family
Allmpus Laboratories manufactures and isolates Roxithromycin impurities alongside the broader macrolide family, including Erythromycin- and Clarithromycin-related compounds, reflecting the structural overlap between these APIs. Each impurity is supplied with a Certificate of Analysis supported by ¹H NMR, ¹³C NMR, mass spectrometry, HPLC, IR, and TGA data, with SMILES and molecular formula confirmation available for structural verification prior to use in method development, method validation, or routine QC testing. Allmpus's Roxithromycin impurity portfolio, including EP Impurity I, is manufactured and stocked at its Dombivali, Maharashtra facility, supporting supply to pharmaceutical manufacturers and contract testing laboratories working across the erythromycin-derived macrolide class.
Frequently Asked Questions
Are Allmpus Roxithromycin impurity standards referenced to EP and USP designations?
Yes. Where a pharmacopeial designation exists, the corresponding EP impurity letter is provided along with the chemical name and any cross-reference to related Erythromycin or Clarithromycin impurity designations, to support direct use in monograph-based testing.
What analytical data is provided with each impurity standard?
Each standard is issued with a Certificate of Analysis that includes NMR (¹H and ¹³C), mass spectrometry, HPLC purity, IR, and TGA data to support identity and purity confirmation.
Are these standards suitable for human use?
No. Roxithromycin impurity standards are supplied strictly for analytical, research, and reference purposes, including method development and quality control testing, and are not intended for human or veterinary administration.