Also known as TT8UT4A8Z2, Linagliptin Impurity 65, Linagliptin Impurity 88
Linagliptin dimer, CAS 2489212-72-6, formula C51H56N16O4 and molecular weight 957.1, is a linagliptin-related dimeric compound used primarily in analytical, pharmaceutical research and impurity-characterisation work.
Pharmaceutical intermediates and research chemicalsLinagliptin-related impurity and analytical reference compound
Product identity
CAS number
2489212-72-6
Molecular formula
C51H56N16O4
Molecular weight
957.1 g/mol
Category
Pharmaceutical intermediates and research chemicals
Subcategory
Linagliptin-related impurity and analytical reference compound
Linagliptin dimer is a linagliptin-related dimeric organic compound identified by CAS 2489212-72-6. Its systematic name describes two closely related purine-dione-derived units connected through substituted piperidine and amino-methyl functionality. The molecular formula is C51H56N16O4, and the stated molecular weight is 957.1. It is also associated with the aliases TT8UT4A8Z2, Linagliptin Impurity 65 and Linagliptin Impurity 88.
The molecule contains multiple nitrogen-rich heterocyclic and amine functionalities, two quinazoline-containing substituent systems, carbonyl groups, and but-2-ynyl and methyl substituents. These structural features indicate a comparatively large, multifunctional organic species whose chromatographic behaviour can differ substantially from monomeric linagliptin. Its response, retention and solution behaviour may depend on solvent composition, concentration, temperature and the analytical technique selected.
Linagliptin dimer is principally encountered in pharmaceutical analytical chemistry, impurity profiling, method development and research concerning linagliptin-related substances. It can support examination of process-related or degradation-related components when an appropriately characterised material is required for comparison. A common use as an analytical reference does not, by itself, establish suitability for medicinal administration, finished-product manufacture or any particular regulated application.
Selection should begin with the intended analytical question, the required identity assignment and the relationship between this dimer and the linagliptin method under study. Buyers should compare the stated molecular formula, molecular weight and synonym set with their internal records, then assess solvent compatibility and detector response experimentally. Suitability remains dependent on the specific material, method, jurisdiction and documented technical requirements. For commercial selection, the compound name should be considered separately from the specification and supplied form required for the intended process.
Technical profile
Product properties
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Linagliptin dimer combines two linagliptin-related structural domains within one high-molecular-weight molecule. Its C51H56N16O4 composition reflects extensive nitrogen content, several carbonyl groups and aromatic heterocyclic features. This architecture can produce analytical behaviour distinct from linagliptin itself, particularly in reversed-phase separations and mass-spectrometric investigations. Analysts should therefore treat the dimer as a separate chemical entity rather than assuming that monomer data transfer directly.
The stated molecular weight of 957.1 provides a practical starting point for mass-based calculations, while the systematic name helps distinguish the compound from similarly described linagliptin impurities. Multiple basic or hydrogen-bonding sites may influence ionisation and retention, but observed results remain method-dependent. Chromatographic peaks, adducts and fragmentation patterns should be interpreted alongside suitable controls and orthogonal evidence when structural assignment is important.
Relationship to linagliptin and related impurities
Linagliptin dimer differs from linagliptin because it contains two linked, related molecular portions rather than a single monomeric framework. That difference can increase molecular size and alter polarity distribution, steric accessibility, ionisation response and chromatographic retention. It should not be treated as interchangeable with linagliptin, with another impurity, or with a generic dimer designation unless the analytical identity has been specifically demonstrated.
The aliases Linagliptin Impurity 65 and Linagliptin Impurity 88 may appear in technical records, but nomenclature alone does not establish equivalence across every method or supplier record. Laboratories comparing historical results should reconcile the name, CAS number, formula and observed analytical behaviour. When a different linagliptin-related substance is under investigation, separate qualification is appropriate rather than relying on assumed structural similarity.
Analytical method development considerations
Linagliptin dimer may be useful when developing or challenging chromatographic methods intended to resolve high-molecular-weight linagliptin-related components. Its many heteroatoms and carbonyl-containing groups can affect aqueous-organic partitioning, peak shape and detector response. Method developers commonly examine column chemistry, mobile-phase pH, gradient conditions and injection solvent together, because changing one factor can alter apparent separation of closely related species.
For mass spectrometry, the nitrogen-rich structure may support several ionisation states or adduct patterns, depending on source conditions and mobile-phase composition. The calculated molecular mass should guide expected ion investigation, not replace experimental confirmation. Solution concentration, equilibration time and sample preparation can also influence apparent recovery. Results should be interpreted using the actual method and material rather than broad expectations for linagliptin compounds.
Use in impurity and process investigations
Linagliptin dimer can support investigations into unexpected or known high-mass components observed during pharmaceutical development. Analysts may compare retention, mass response and fragmentation with an independently prepared sample to strengthen peak assignment. Such work is especially relevant when a process, formulation or stress study produces a signal that is not adequately explained by the parent compound or simpler related substances.
Its use as an analytical reference does not automatically define the origin of a detected peak. Formation pathways may depend on reaction conditions, concentration, time, moisture, temperature and other system-specific variables. The dimer should therefore be used to support an evidence-based assignment, alongside suitable separation and structural techniques. A particular material’s suitability for a regulated method remains dependent on laboratory qualification and applicable requirements.
Frequently asked questions
Questions about Linagliptin dimer
How does Linagliptin dimer differ from linagliptin?
Linagliptin dimer is a larger, dimeric linagliptin-related compound, whereas linagliptin is a single molecular entity. The dimer has the formula C51H56N16O4 and a stated molecular weight of 957.1, reflecting two related structural domains within one molecule. This difference can change chromatographic retention, ionisation, solubility behaviour and fragmentation compared with the parent compound. Consequently, linagliptin dimer should be evaluated as a distinct analytical substance, not used as a direct substitute for linagliptin. Its value generally lies in impurity profiling, method development and structural investigations where a high-mass related component requires comparison or confirmation.
What is Linagliptin dimer commonly used for?
Linagliptin dimer is commonly used in pharmaceutical analytical research, impurity profiling and development of methods for examining linagliptin-related substances. Laboratories may use it to compare chromatographic retention, investigate mass-spectrometric signals or support assignment of a high-molecular-weight component observed during development or stress studies. It can also contribute to broader research on process-related impurities and degradation behaviour. These uses are analytical and investigational. They should not be interpreted as evidence that the compound is an active pharmaceutical ingredient, a finished-product ingredient or suitable for administration. The appropriate application depends on the material and method.
Why can a dimeric impurity show different chromatographic behaviour?
A dimeric impurity has greater molecular size and a different distribution of hydrophobic, polar, basic and hydrogen-bonding sites than its monomeric counterpart. In Linagliptin dimer, several nitrogen-containing groups and carbonyl functionalities occur within a large connected structure, which can influence stationary-phase interactions and solvent partitioning. The compound may therefore elute earlier or later than expected from simple molecular-weight comparisons. Mobile-phase pH, organic modifier, column chemistry, temperature and injection solvent can all affect observed separation. Experimental method development remains necessary because structural predictions do not guarantee a particular retention order. The final decision should consider the supplied Linagliptin dimer specification, intended process and applicable requirements rather than the chemical name alone.
Can Linagliptin dimer serve as a general linagliptin reference standard?
No. Linagliptin dimer is a specific related compound and should not automatically be treated as a general reference for linagliptin or for every linagliptin impurity. Its formula, molecular weight, structure and analytical response are different from those of the parent molecule. It may be appropriate when the analytical target is the dimer itself or when a method requires a representative high-mass related substance. For identity, assay, related-substance or stability work, the laboratory should establish that the selected material matches the intended analyte and performs appropriately under the method being used.
What should analysts consider when preparing Linagliptin dimer solutions?
Analysts should consider solvent compatibility, target concentration, mixing time, possible adsorption, solution stability and the detection technique before preparing Linagliptin dimer solutions. Its large, multifunctional structure may not behave like a small, simple organic compound in every solvent system. The selected diluent should be compatible with the separation method and should not create precipitation, excessive peak distortion or detector interference. Solution appearance and analytical response can be checked during method development, while preparation conditions should be aligned with the laboratory’s validated or experimentally justified procedure. No single solvent or concentration is universally suitable.
Do the aliases Linagliptin Impurity 65 and Linagliptin Impurity 88 describe the same material?
The supplied identity information associates Linagliptin dimer with both Linagliptin Impurity 65 and Linagliptin Impurity 88, as well as the alias TT8UT4A8Z2. However, an alias should be interpreted within the specific technical record where it appears. Numbering conventions can differ between methods, development programs or documentation systems, and similar labels may not always establish structural equivalence by themselves. For dependable identification, compare the complete chemical name, CAS number, molecular formula, molecular weight and analytical data. When records conflict, the intended analyte should be resolved through appropriate technical review rather than name matching alone.
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