During drug development, Active Pharmaceutical Ingredients (APIs) and formulations are exposed to various stress factors—such as heat, light, pH, oxidation, and humidity—which can lead to chemical instability. Understanding the resulting degradation products is essential for optimizing molecular structures, selecting appropriate excipients, and ensuring the safety of research materials. BOC Sciences offers comprehensive degradation product analysis services to identify, isolate, and characterize impurities formed under storage, processing, or simulated physiological conditions. Utilizing advanced mass spectrometry (HRMS) and NMR technologies, we help clients elucidate complex degradation pathways, differentiate between process impurities and degradants, and provide data-driven insights to accelerate lead optimization and formulation development.
We provide definitive structural answers for unknown peaks appearing in your chromatography, converting data into chemical knowledge.
We go beyond "what" to answer "how" and "why," mapping the chemical journey from parent molecule to final degradant.
Evaluating how materials and molecules break down under biological influence, crucial for environmental fate and drug delivery design.
Quantifying the impact of physical and chemical factors on molecular integrity, independent of biological systems.
Proactive stress testing to predict stability liabilities and identify "soft spots" in your molecule's structure.
Targeted analysis of degradation occurring during specific manufacturing or experimental workflows.
BOC Sciences specializes in solving complex structural puzzles. Our experts utilize state-of-the-art spectroscopy to characterize degradation products rapidly.
Ultra-Performance Liquid Chromatography coupled with Photo-Diode Array and Mass Spectrometry is our primary tool for separating complex mixtures and obtaining preliminary UV spectral and molecular weight data for degradants.
To determine the exact elemental composition of degradation products, we employ HRMS. Accurate mass measurements allow us to propose molecular formulas and fragmentation patterns with high confidence.
For definitive structural confirmation, particularly for isomers, we use high-field NMR (up to 600 MHz). Techniques like NOESY and HMBC help determine the precise location of degradation modifications.
When on-line characterization is insufficient, we scale up separation using Prep-LC to collect mg-quantities of the impurity. This enriched material is essential for detailed NMR analysis and reference standard generation.
We employ Gas Chromatography-Mass Spectrometry to analyze volatile degradation products, providing insights into solvent interactions, oxidation byproducts, or small molecule cleavage fragments.
BOC Sciences accepts a wide variety of matrices, helping clients understand stability across the entire discovery and development spectrum.
Send us your chromatograms or samples. Our structural chemistry experts are ready to design a degradation study tailored to your compound's unique properties.
We review your existing data (structures, chromatograms). Our chemists propose a stress testing protocol or an isolation strategy best suited for your target impurities.
We perform forced degradation or utilize your degraded samples. Using Prep-LC, we enrich and isolate the specific degradation products of interest for characterization.
Isolated compounds undergo comprehensive analysis using HRMS (MS/MS fragmentation) and multi-dimensional NMR to determine connectivity and stereochemistry.
We deliver a detailed structural elucidation report, including proposed structures, degradation mechanisms, and raw spectral data to support your R&D decisions.
Speed and capital efficiency are vital for early-stage ventures. We act as your virtual analytical laboratory, providing rapid forced degradation studies to identify molecular "soft spots" immediately. Our data packages are designed to quickly de-risk lead candidates and support robust intellectual property filings without the need for heavy internal infrastructure investment.
We serve as a specialized extension of your internal capabilities, tackling the "cold cases" that standard workflows cannot resolve. When you face ambiguous isomeric impurities or trace-level degradants that stall projects, our expert team utilizes advanced orthogonal spectroscopy (high-field 2D-NMR) to provide definitive structural elucidation for your most challenging molecules.
We support scale-up efforts by mapping the fate of impurities throughout the synthetic route. Our real-time analysis identifies reaction byproducts and degradation triggered by processing conditions (e.g., heat, pH), enabling you to refine purification steps, validate cleaning protocols, and ensure batch-to-batch consistency for your clients.
We offer specialized testing for complex matrices, from solid oral dosages to LNPs. We go beyond the API to analyze API-excipient interactions (e.g., Maillard reactions) and degradation within the final drug product, guiding you to select the most compatible buffers, carriers, and packaging materials for long-term shelf stability.
Don't let unknown impurities stall your project. Partner with BOC Sciences for expert degradation product analysis. We turn undefined peaks into actionable structural information, ensuring your development moves forward with confidence.
Our team consists of PhD-level chemists with extensive experience in natural product chemistry and impurity profiling, capable of solving the most challenging structural puzzles without relying solely on library matching.
We operate advanced analytical platforms including Q-TOF, Orbitrap MS, and 600 MHz NMR with cryoprobes, ensuring sensitivity for trace-level degradants (often <0.1%).
Unlike standard analytical labs, we seamlessly integrate Prep-LC and semi-prep fractionation. We don't just detect the impurity; we isolate enough of it to perform definitive 2D-NMR characterization.
We provide more than just data; we offer chemical logic. Our reports explain the degradation mechanisms, helping you understand the root cause of instability in your storage or formulation environment.
Client Needs: A client developing a lipid-based formulation observed an unknown impurity increasing over time at 4°C. They needed to identify the structure to understand if it was a hydrolysis product or an oxidative byproduct.
Challenges: The impurity was present at very low levels (0.2%) and was structurally very similar to the parent lipid, making separation difficult. Standard LC-MS provided inconclusive fragmentation patterns due to the aliphatic nature of the chain.
Solution: BOC Sciences implemented a multi-dimensional approach, employing orthogonal chromatography for effective sample enrichment followed by advanced high-resolution MS/MS analysis. To achieve definitive structural assignment, we utilized specialized 2D-NMR pulse sequences (including COSY and HMBC), which pinpointed the exact location of the oxidative modification on the unsaturated fatty acid chain with high precision.
Outcome: We identified the degradation mechanism as auto-oxidation. The client was able to add a specific antioxidant to the formulation, effectively halting the degradation and saving the formulation candidate.
Client Needs: A promising lead compound showed yellowing upon exposure to ambient light. The client required a rapid assessment of the photoproducts to determine if the chromophore could be modified.
Challenges: The photoproducts were unstable and reverted to the parent compound during standard rotary evaporation, making isolation tricky.
Solution: Leveraging our specialized flow-chemistry platform, we established an online LC-Photo-MS system to capture and characterize the elusive transient species in real-time. To prevent reversion during isolation, we executed a rapid, cold-temperature purification protocol, successfully obtaining stable material for comprehensive structural validation via cryogenic NMR spectroscopy.
Outcome: The structure of a photocyclized product was elucidated. The medicinal chemistry team modified a specific substituent on the aromatic ring, significantly improving light stability without losing potency.
Client Needs: During accelerated stability testing of a solid dosage form, a new peak appeared. The client suspected an interaction with the lactose filler (Maillard reaction) but lacked proof.
Challenges: The matrix was complex, containing multiple excipients. The degradation product was highly polar and not retained on standard C18 columns.
Solution: Addressing the polarity challenge, our experts developed a robust HILIC (Hydrophilic Interaction Liquid Chromatography) method to successfully retain and separate the polar degradant. Subsequent high-accuracy Q-TOF MS analysis identified a distinct mass shift, providing unequivocal evidence of a glycosylamine adduct formed through the specific API-lactose interaction.
Outcome: Confirmed the formation of a Maillard reaction product. The client switched to an anhydrous excipient (Mannitol), resolving the instability issue for the next batch production.
Degradation product analysis is performed to systematically identify structural changes and by-products formed under different conditions, serving as an essential approach to understanding compound stability behavior. By clarifying major and potential degradation pathways, clients can better assess molecular characteristics and risk points. BOC Sciences leverages established analytical platforms to deliver high-resolution and traceable degradation product characterization services.
Common degradation pathways typically involve structural changes induced by hydrolysis, oxidation, light exposure, or thermal stress. Based on molecular features and application scenarios, BOC Sciences designs systematic degradation study strategies and applies multidimensional analytical techniques to help clients comprehensively understand degradation behaviors and underlying mechanisms.
Accurate identification relies on high-sensitivity detection and advanced structural elucidation capabilities. BOC Sciences integrates chromatographic separation with high-resolution mass spectrometry and extensive spectral interpretation expertise to precisely characterize degradation components in complex samples, supporting unknown component elucidation and structural confirmation.
Degradation product analysis results can be used to compare stability differences under various conditions and identify key degradation trends. Alongside comprehensive data delivery, BOC Sciences provides expert interpretation grounded in chemical structure logic, enabling clients to rapidly focus on critical issues and refine research strategies.
Complex samples often present challenges such as multiple components, weak signals, and significant interference. BOC Sciences addresses these demands through method development and condition optimization, enhancing separation efficiency and detection sensitivity while applying customized analytical workflows to ensure clarity and reliability of degradation product analysis outcomes.
We had an unidentified peak stalling our formulation selection for months. BOC Sciences isolated the material and provided a clear NMR structure within two weeks. Their insight into the degradation pathway was impressive.
— Dr. Arthur, Director of Chemistry, Biotech Startup
The technical report provided was detailed and scientifically robust. They didn't just give us a spectrum; they interpreted the fragmentation patterns and explained the chemistry. A true research partner.
— Dr. Lucas, Principal Scientist, Pharmaceutical R&D
We use BOC Sciences for rapid stress testing of our hit compounds. Their data helps us filter out unstable scaffolds early, saving us resources downstream. Highly recommended for lead optimization support.
— Dr. Jason, Head of Medicinal Chemistry
Our molecule had multiple chiral centers and the degradation product was an isomer. BOC Sciences' NMR team did a fantastic job distinguishing the diastereomers and assigning the structure.
— Dr. Thomas, Senior Researcher, Drug Discovery Firm
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