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What if different methods give different results?
Differences can result from sample heterogeneity, matrix effects, or the measurement principles of each method. We review preparation, working range, and orthogonal evidence to provide a consistent interpretation and practical next steps.
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What do you deliver at the end of a project?
Deliverables typically include a fit-for-purpose study plan, a technical report with results and interpretation, and raw data exports where applicable. Qualification or validation summaries can also be provided within the agreed scope.
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How do you ensure accurate primary structure characterization for biologics?
We build orthogonal evidence using intact mass by HRMS (e.g., Orbitrap, Q-TOF), LC-MS/MS peptide mapping for sequence confirmation, and targeted PTM/disulfide/conjugation analysis to verify identity and structural fidelity.
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Which orthogonal methods do you use for higher-order structure (HOS) assessment?
We combine far/near-UV CD, FTIR, fluorescence, NMR (1D/2D), DSC, SEC-MALS/AF4-MALS, and AUC to profile secondary/tertiary structure, conformational stability, and aggregation under near-native conditions.
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What is the customization process for reference standards? How to obtain the complete list of in-stock impurities?
We will provide a quotation based on your requirements for the purity and quantity of the reference standards. Please contact our customer service to receive the latest product catalog.
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Does Milestone Pharma impurity research and reference standard preparation services comply with global drug registration requirements? Can Milestone Pharma support clients through regulatory on-site inspections?
Milestone Pharma strictly follows the requirements of a quality control laboratory system. All experimental processes are complete and traceable, meeting the drug registration requirements of major global regulatory authorities (e.g., NMPA, FDA, EMA, etc.).
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Why are nitrosamine impurities (including NDSRIs) a key regulatory focus?
Nitrosamine impurities are potentially mutagenic (DNA-reactive) compounds, so even trace levels can raise significant regulatory concern. Regulators therefore expect a clear, science-based control strategy covering risk assessment, fit-for-purpose testing, and defensible limits for both nitrosamines and nitrosamine drug substance-related impurities (NDSRIs).
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