Pharma QC & impurity analysis
Robust HPLC/UHPLC methods, certified impurity standards and the instruments to run them — everything a QC or ARD lab needs for release testing, stability studies and regulatory filings.
QC and analytical R&D labs at generic and innovator pharma companies, CROs and API manufacturers.
Challenges we help solve
Gradient impurities from mobile phase interfere with low-level impurity peaks.
Specified impurities for ANDA/DMF work are often unavailable or slow to import.
Methods must transfer between sites and survive column lot changes.
The workflow, step by step
- 1Method development
Screen phases and pH to separate API from all specified impurities.
Welch Ultisil®, Xtimate®, Boltimate® - 2Reference standards
Identify and quantify impurities against certified standards.
TLC impurity standards - 3Validation & transfer
Prove specificity, linearity and robustness; transfer to QC.
Welchrom® equivalents · TLC CoA - 4Routine release & stability
Run day-to-day testing with clean baselines.
Ghost-Buster™ · Inscinstech HPLC
Recommended products
11 products for this workflow. Click a picture for a quick view, or add products to your quote list.