China HPLC Testing Manufacturers & Suppliers

Validation protocols comply strictly with ICH Q2(R1) and USP <1225>. We quantify Specificity (resolving degradation impurities from main actives), Linearity (R² ≥ 0.999 over 50%–150% target concentration), Accuracy/Recovery (typically 98.0%–102.0% spike recovery across low, mid, and high levels), Precision (Repeatability and Intermediate Precision RSD ≤ 2.0%), Robustness (deliberate variations in flow rate ±10%, column temperature ±2°C, and mobile phase pH ±0.2 units), alongside Limit of Detection (LOD) and Limit of Quantitation (LOQ).

Botanical matrices typically contain hundreds of structurally related phenolics and terpenes. Our lab implements multi-stage selectivity strategies: evaluating stationary phase chemistry orthogonalities (e.g., swapping C18 for Pentafluorophenyl or HILIC), adjusting organic modifier ratios (methanol vs. acetonitrile selectivity), exploring mobile phase modifiers (formic acid, ammonium acetate buffers), and employing photodiode array (PDA) spectral deconvolution and LC-MS peak identification.

Yes. As an integrated CRO/CDMO platform, our analytical laboratories are located within direct communication reach of our extraction pilot facilities and commercial manufacturing sites. When a method is validated, our scientists author complete Analytical Method Transfer (AMT) protocols and oversee co-validation at the plant floor QC laboratory, eliminating typical communication voids between independent CRO labs and external contract factories.

Beyond standard reversed-phase and normal-phase HPLC, our laboratories utilize High-Performance Thin-Layer Chromatography (HPTLC) for qualitative fingerprinting and rapid TLC profiling, Gas Chromatography (GC and GC-MS/MS) for volatile terpenes and residual solvent quantitation, and modern chromatographic fingerprinting software calculating similarity values (cos θ) against botanical reference materials.

We operate exclusively under legally binding Non-Disclosure Agreements (NDAs). Each client project is assigned an internal encrypted code, restricting formulation and analytical parameters solely to the dedicated project team. All test findings, chromatography datasets, gradient settings, and scale-up engineering metrics are client-exclusive IP without external disclosure.

Our finished-product validation division supports oral liquids, hard-shell capsules, softgels, micro-tablets, effervescent granules, and soluble botanical powders. We conduct finished-dosage content uniformity, dissolution profile testing, accelerated stability, and long-term ICH climatic zone testing (Zone II and Zone IVb).