The Quality Control (QC) laboratory performs all analytical and microbiological testing required to release DEFRATAJ batches against their approved specification. The laboratory is purpose-built, adequately staffed with qualified analysts, and operates under documented methods validated per ICH Q2(R1).
Laboratory Organisation #
- Dedicated chemical analysis laboratory (HPLC, UV-Vis, FTIR, KF, titrimetry, dissolution testers)
- Separate microbiology laboratory for bioburden, sterility-support and water testing (as applicable)
- Stability chambers qualified for ICH long-term, intermediate and accelerated conditions
- Controlled reference-standard and reagent storage
- Validated chromatography data system (CDS) with audit trails and user access controls
Testing Scope for DEFRATAJ Dispersible Tablets #
| Test | Method |
|---|---|
| Identification of Deferasirox | HPLC retention; FTIR comparison with reference |
| Assay (content) | HPLC against reference standard; specification typically 95.0-105.0% |
| Uniformity of Dosage Units | Per pharmacopoeial method (USP <905> / Ph. Eur. 2.9.40) |
| Dissolution | USP apparatus 2 (paddle); pharmacopoeial / validated in-house method |
| Disintegration | Rapid disintegration specification for dispersible tablet |
| Related Substances / Impurities | HPLC gradient method; ICH Q3B reporting/identification/qualification thresholds |
| Water content | Karl Fischer titration |
| Tablet physical attributes | Hardness, friability, thickness, weight variation |
| Microbiological limits | Total aerobic microbial count, yeasts/moulds, absence of specified organisms (per pharmacopoeia) |
Method Validation #
All in-house methods are validated per ICH Q2(R1) for Specificity, Linearity, Range, Accuracy, Precision (repeatability and intermediate precision), Detection/Quantitation Limits (for impurity methods), and Robustness. Validation reports are maintained and re-verified on method transfer or significant change.
Reference Standards #
Primary reference standards are sourced from pharmacopoeial bodies (USP, Ph. Eur., IP) or qualified in-house against primary standards. Working standards are qualified, controlled and tracked through the laboratory information system.
Out-of-Specification (OOS) Handling #
OOS results trigger a formal, documented investigation per a written SOP - including laboratory phase (method, instrument, analyst review) and, where warranted, manufacturing phase investigation. OOS decisions are signed off by QA; root cause and CAPA are tracked.