Data That Stands Up to Regulatory Scrutiny
Every compound we synthesise is backed by a complete analytical package — from structural confirmation to purity profiling — ready for ICH-compliant regulatory submissions.
From Synthesis to Submission-Ready Documentation
Our analytical workflow is designed around the regulatory lifecycle of a pharmaceutical compound — ensuring every data point is traceable, reproducible, and submission-ready.
Structural Confirmation
Before any purity work begins, we confirm the identity of the synthesised compound using NMR (¹H and ¹³C), IR spectroscopy, and mass spectrometry (LC-MS or GC-MS). This rules out regioisomers, by-products, and unexpected structural changes during synthesis.
Instruments Used
Output
Purity Assessment
HPLC is the primary tool for purity determination. We develop and validate methods appropriate to the compound class, quantifying all related substances against ICH Q3A/Q3B thresholds. Residual solvents are quantified by GC per ICH Q3C.
Instruments Used
Output
Physical Characterisation
Physical properties are measured to support formulation, stability, and regulatory filings. This includes water content (Karl Fischer), melting point and polymorphic form (DSC), thermal stability (TGA), and optical rotation for chiral compounds (polarimetry).
Instruments Used
Output
Elemental Composition
CHN(S) elemental analysis confirms the empirical formula of the synthesised compound, providing an independent cross-check of structural identity. This is particularly important for novel impurity standards and reference compounds submitted to regulatory agencies.
Instruments Used
Output
Certificate of Analysis (CoA) Generation
All analytical data is compiled into a comprehensive Certificate of Analysis. The CoA includes compound identity, molecular formula, molecular weight, appearance, purity (HPLC), water content, residual solvents, and storage conditions — formatted to meet ICH and regulatory agency expectations.
Instruments Used
Output
Full In-House Analytical Suite
All analytical work is performed in-house on calibrated, maintained instruments — no outsourcing, no delays, no gaps in the chain of custody.
Chromatography
High-Performance Liquid Chromatography
Purity, assay, related substances, method development and validation per ICH Q2(R1).
Liquid Chromatography–Mass Spectrometry
Molecular weight confirmation, impurity identification, metabolite profiling.
Gas Chromatography
Residual solvent quantification per ICH Q3C, volatile impurity profiling.
Gas Chromatography–Mass Spectrometry
Identification of volatile compounds and unknown impurities.
Spectroscopy
Nuclear Magnetic Resonance Spectroscopy
¹H and ¹³C NMR for complete structure elucidation and confirmation.
Fourier-Transform Infrared Spectroscopy
Functional group identification, polymorphic form screening.
UV-Visible Spectrophotometry
Quantitative analysis, chromophore detection, molar absorptivity determination.
Physical & Thermal
Differential Scanning Calorimetry
Melting point, polymorphism, purity by DSC, heat of fusion.
Thermogravimetric Analysis
Thermal stability, moisture and solvent content, decomposition profiling.
Karl Fischer Titration
Water content determination (coulometric and volumetric) per ICH Q6A.
Optical Rotation / Polarimetry
Specific optical rotation, enantiomeric excess, chiral purity confirmation.
Elemental
Elemental Analysis (C, H, N, S)
Empirical formula confirmation, independent structural cross-check for regulatory submissions.
What You Receive With Every Order
Our standard analytical package is designed to meet the documentation requirements of ICH, FDA, EMA, and other major regulatory agencies.
Certificate of Analysis (CoA)
Compound identity, purity (HPLC), water content (KF), residual solvents (GC), appearance, storage conditions, and expiry date.
NMR Spectra
¹H and ¹³C NMR spectra with full peak assignments confirming the proposed structure.
HPLC Chromatograms
Purity chromatogram with integration table, method parameters, and system suitability data.
Mass Spectrum
LC-MS or GC-MS spectrum confirming molecular weight and fragmentation pattern.
IR Spectrum
FTIR spectrum for functional group confirmation and polymorphic form identification.
Additional Data on Request
DSC thermogram, TGA trace, elemental analysis, optical rotation, and UV-Vis spectrum available on request or as required by your regulatory submission.
Need a Full Analytical Package?
Tell us your compound, your regulatory target, and your timeline — we'll confirm what analytical data we can provide.
Discuss Your Requirements