What this round covers
- HPLC and GC troubleshooting
- OOS and OOT investigations
- ICH Q2 method validation
- Calibration and system suitability
- Stability testing
10 Quality Control interview questions with answers
- Q1DissolutionBeginner
Which USP chapter covers dissolution testing?
Model answer: USP <711> describes dissolution apparatus, media and acceptance stages S1-S3.
- Apparatus I/II
- S1-S3 stages
- Media and sink conditions
- Q2UniformityIntermediate
USP <905> deals with:
Model answer: <905> covers content uniformity and weight variation with AV calculation.
- Acceptance value
- L1/L2 stages
- 10 then 30 units
- Q3DissolutionIntermediate
Which apparatus is used for capsules that float?
Model answer: Paddle apparatus with a sinker prevents floating capsules from skewing results.
- Sinker justified
- Documented in method
- Consistent placement
- Q4Wet ChemistryBeginner
Karl Fischer titration determines:
Model answer: KF measures water by stoichiometric reaction of iodine with water.
- Volumetric vs coulometric
- Reagent factor
- Moisture-free handling
- Q5HPLCAdvanced
Which detector is most suitable for compounds lacking a chromophore?
Model answer: Universal detectors such as RI, CAD or ELSD detect non-UV-absorbing analytes.
- Detector selection rationale
- Gradient compatibility
- Sensitivity limits
- Q6HPLCBeginner
System suitability in HPLC is performed to:
Model answer: System suitability confirms resolution, tailing, theoretical plates and precision before reporting data.
- Predefined criteria
- Run before and bracket
- Failure means no reportable data
- Q7HPLCIntermediate
Typical acceptance for %RSD of five replicate injections of a standard is:
Model answer: For assay methods, replicate injection precision is usually NMT 2.0% RSD.
- Method specific
- Defined in SOP
- Related substances may allow more
- Q8HPLCIntermediate
Tailing factor above the limit indicates:
Model answer: Excess tailing suggests column degradation, silanol interaction or unsuitable pH.
- Buffer pH adjustment
- Column replacement
- Investigate before use
- Q9HPLCBeginner
Resolution between two adjacent peaks should generally be:
Model answer: Baseline resolution is achieved at Rs of at least 1.5 for accurate quantitation.
- Rs formula
- Critical pair
- Method robustness
- Q10ValidationBeginner
ICH Q2(R2) covers:
Model answer: ICH Q2 defines validation characteristics: specificity, linearity, accuracy, precision, LOD, LOQ, range, robustness.
- Parameter set by test type
- Q14 development link
- Documented protocol
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