Genotoxicity & Impurities
Advanced impurity profiling and potential impurity assessment
Every impurity assessment depends on knowing which impurities could be present. We work through your synthetic route, starting materials, reagents, solvents and degradation pathways to build a complete impurity list — and assess how each one is likely to be removed by the process.
- Guideline basis ICH Q3A(R2), Q3B(R2), Q3C, Q3D and M7(R2)
- Typical inputs Route of synthesis, specifications, batch and stability data
- You receive Impurity profile report with fate and purge assessment
Overview
About Advanced Impurity Profiling
Impurity profiling is often treated as an analytical exercise, but regulators also expect a theoretical assessment: what could form, where it could come from and whether the process removes it. Gaps in this reasoning are a frequent cause of dossier queries.
We review the chemistry step by step, map each actual and potential impurity to its origin and consider its fate through later steps. Where analytical data exist, we reconcile them with the theoretical profile and highlight where further testing is warranted.
Use cases
When this service helps
Preparing a DMF or Module 3
A complete, reasoned impurity discussion for the drug substance section.
Route or supplier change
Identify any new impurities introduced by the change.
Answering a deficiency letter
Explain the origin and control of an impurity raised by the authority.
Setting specifications
Provide the basis for which impurities to test and at what limits.
Scope
What the service covers
- Review of the route of synthesis, starting materials, reagents, catalysts and solvents
- Identification of actual and potential process impurities and by-products
- Degradation pathways from forced-degradation and stability data
- Fate and purge assessment across subsequent process steps
- Residual solvent (ICH Q3C) and elemental impurity (ICH Q3D) considerations
- Comparison of the theoretical profile with batch analysis data
- Recommendations on specifications and further analytical work
Who does what
Analytical testing is performed by your quality-control laboratory or a contract laboratory. Globaxa provides the scientific assessment and can specify what testing is needed.
What is a purge factor?
A purge factor estimates how effectively a process step removes an impurity, based on properties such as reactivity, solubility and volatility. Combined across steps, purge factors can support an ICH M7 Option 4 control strategy without routine testing — provided the argument is well justified.
Methodology
How we work
A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.
- Collect route informationProcess description, materials and batch data.
- Map impuritiesEach potential impurity is linked to its source and stage.
- Assess fate and purgePhysicochemical properties and process conditions are used to estimate removal.
- Reconcile with dataTheoretical predictions are compared with analytical results.
- ReportA structured impurity profile ready for the dossier.
Deliverables
What you receive
Impurity profile report
Origins, structures, fate and recommended controls for each impurity.
Impurity table
A summary table suitable for specifications and Module 3.
Recommendations
Gaps in data or control, with proposed actions.
Technical basis
Guidelines we work to
- ICH Q3A(R2) and Q3B(R2)Reporting, identification and qualification thresholds for impurities in drug substances and products.
- ICH M7(R2)Assessment and control of DNA-reactive (mutagenic) impurities.
- ICH Q3C and Q3DResidual solvents and elemental impurities.
- ICH Q11Development and manufacture of drug substances, including control strategy.
What we need from you
- Route of synthesis with reaction conditions and work-up steps
- Starting material, reagent and solvent lists with supplier information
- Drug substance and product specifications
- Batch analysis, forced-degradation and stability data
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
The ICH Q3 and M7 guidelines are applied by ICH regulators and widely referenced by other authorities, including many in Africa and Asia. National pharmacopoeial requirements may add specific impurity tests.
FAQs
Advanced Impurity Profiling: frequently asked questions
Do you need our full process details?
Yes — the assessment is only as good as the route information. We sign a non-disclosure agreement before any confidential process information is shared.
Can you identify unknown peaks?
Structural elucidation requires analytical work in a laboratory. We can propose likely structures from the chemistry and advise on the analytical approach.
Is this the same as an ICH M7 assessment?
It is the first step. The impurity list feeds the (Q)SAR assessment and ICH M7 classification.
Talk to us about Advanced Impurity Profiling
Share your product, target market and timeline. We will review your requirement and propose a defined scope.
- OfficeFlat no 8-9-3/23/1, Subhash Chandra Bose Colony, Dathunagar, Kanchanbagh, Hyderabad, Telangana 500058, India
Open in Google Maps - Phone+91 81219 33381
+91 99894 74590 - Emailbd@globaxa.in
- Office hoursMonday to Friday, 10:00–19:00 IST