HPLC-UV / HPLC-DAD
The gold standard for assay and impurity profiling.
High-performance liquid chromatography with UV/DAD detection is the backbone of pharmaceutical QC. We separate complex mixtures into individual components and quantify each one with 0.01 % LOQ.
What we measure
- Active compound assay per USP / Ph. Eur.
- Organic impurity profile (specified + unspecified + total)
- Uniformity of dosage units (Ph. Eur. 2.9.40)
- Dissolution testing (Ph. Eur. 2.9.3)
- Stability studies: accelerated 40 °C / 75 % RH, long-term 25 °C / 60 % RH
- Method validation per ICH Q2(R1)
- Batch-to-batch comparison for production control
Typical: 10–50 mg raw material / 20 tablets / 2 ampoules. Samples accepted in original sealed container with batch code. Chain of custody receipt (Ph. Eur. 5.1) issued within 2 h of intake.
Instruments + methods
Technical specs- Detector
- UV 190–400 nm + DAD (200–600 nm)
- Columns
- C18, C8, HILIC, chiral (Chiralpak)
- Flow rate
- 0.1–2.0 ml/min
- Column oven
- up to 80 °C (±0.1 °C)
- Autosampler
- 120-position, 0.1–100 µl injection
- Accreditation
- ISO/IEC 17025 (scope AL-1142/HPLC)
Related questions
03 Q- 01
How much sample is needed?
For standard assay — 100 mg raw material or 20 tablets / capsules. For impurity profile typically 2× more. Exact requirements confirmed before intake.
- 02
Do you perform HPLC method validation?
Yes. Full validation per ICH Q2(R1): specificity, linearity, accuracy, precision, LOD/LOQ, robustness, stability-indicating. Validation report is a separate 20–40 page document.
- 03
Does the DAD detector distinguish isomers?
DAD compares UV spectra 200–600 nm, enabling subtle difference detection. For structural confirmation of isomers we route to NMR (qNMR) or mass spec.