Dalbavancin Impurities

Dalbavancin is a second-generation lipoglycopeptide antibiotic used for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA). It acts by inhibiting bacterial cell wall synthesis through binding to the D-alanyl-D-alanine terminus of peptidoglycan precursors, preventing cross-linking and cell wall formation.
Dalbavancin is notable for its extremely long half-life (~14 days), allowing for once-weekly intravenous dosing, which improves patient compliance and reduces hospitalization needs.
Indications include:
∙ Acute bacterial skin and skin structure infections (ABSSSI) in adults and pediatric patients
∙ Especially effective against MRSA, Streptococcus pyogenes, and other Gram-positive pathogens

Structure

Product Name

CAS No.

Cat No.

Action

Dalbavancin A0 Impurity

Dalbavancin A0 Impurity

Parent: Dalbavancin

CAS No.: 171500-81-5

Cat No.: VE0022218

Dalbavancin A1 Impurity

Dalbavancin A1 Impurity

Parent: Dalbavancin

CAS No.: 171500-80-4

Cat No.: VE0022219

Dalbavancin B1 Impurity

Parent: Dalbavancin

CAS No.: 171500-82-6

Cat No.: VE0022216

Dalbavancin B2 Impurity

Parent: Dalbavancin

CAS No.: 871132-03-5

Cat No.: VE0022217

Dalbavancin D0 Impurity

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0022213

Dalbavancin D1 Impurity

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0022215

Dalbavancin R1 Impurity

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0022211

Dalbavancin R2 Impurity

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0022212

Dalbavancin R6 Impurity

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0022214

N-Nitroso Dalbavancin

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0019472

N-Nitroso Desmethyl Dalbavancin A0 Impurity 1

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026883

N-Nitroso Desmethyl Dalbavancin A0 Impurity 2

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026885

N-Nitroso Desmethyl Dalbavancin A0 Impurity 3

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026887

N-Nitroso Desmethyl Dalbavancin A0 Impurity 4

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026890

N-Nitroso Desmethyl Dalbavancin A1 Impurity 1

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026881

N-Nitroso Desmethyl Dalbavancin A1 Impurity 2

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026884

N-Nitroso Desmethyl Dalbavancin A1 Impurity 3

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026889

N-Nitroso Desmethyl Dalbavancin A1 Impurity 4

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026891

N-Nitroso Desmethyl Dalbavancin B1 Impurity 1

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026876

N-Nitroso Desmethyl Dalbavancin B1 Impurity 2

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026877

N-Nitroso Desmethyl Dalbavancin B1 Impurity 3

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026878

N-Nitroso Desmethyl Dalbavancin B1 Impurity 4

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026879

N-Nitroso Desmethyl Dalbavancin B2 Impurity 1

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026893

N-Nitroso Desmethyl Dalbavancin B2 Impurity 2

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026895

N-Nitroso Desmethyl Dalbavancin B2 Impurity 3

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026897

N-Nitroso Desmethyl Dalbavancin B2 Impurity 4

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026902

N-Nitroso Desmethyl Dalbavancin Impurity 1

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026894

N-Nitroso Desmethyl Dalbavancin Impurity 2

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026898

N-Nitroso Desmethyl Dalbavancin Impurity 3

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0026900

N-Nitroso-Desmethyl-Dalbavancin Impurity

Parent: Dalbavancin

CAS No.: N/A

Cat No.: VE0024905

Dalbavancin Related Compound

Impurities in dalbavancin arise from its fermentation-based production and semi-synthetic modification of glycopeptide structures, as well as from degradation under stress conditions. As a parenteral antibiotic used in critical infections, impurity levels must be strictly controlled according to ICH Q3A/B, USP, EP, and injectable drug regulations.

Types of Impurities in Dalbavancin

Process-Related Impurities

Residual by-products from fermentation (e.g., vancomycin-like glycopeptide analogs)
Incomplete lipidation intermediates
Synthetic by-products from acylation, alkylation, or protecting group removal
Residual solvents such as acetone, methanol, or dimethylformamide (DMF)

Degradation Impurities

Hydrolyzed forms of dalbavancin under acidic or enzymatic conditions
Oxidation products at aromatic or aliphatic sites
Epimerization or rearrangement of peptide bonds
Light- and heat-sensitive cleavage products of the lipid tail or sugar moieties

Elemental Impurities

Trace metals such as iron, copper, or zinc from fermentation vessels or synthesis steps
Regulated under ICH Q3D, with parenteral exposure limits

Analytical Techniques for Impurity Detection

High-Performance Liquid Chromatography (HPLC) – primary method for impurity profiling and assay
LC-MS/MS (Liquid Chromatography–Tandem Mass Spectrometry) – for trace-level impurity identification and confirmation
Gas Chromatography (GC) – for detecting residual solvents
ICP-MS – for elemental impurity detection
Peptide mapping and UV-Vis spectroscopy – for structural integrity and purity checks

FAQ