Introduction: A Chromatographic Data System (CDS) is essential for B. Pharm students learning modern chromatography workflows. CDS software manages instrument control, data acquisition, chromatograms, peak integration, quantitative calculations and reporting for HPLC, GC and LC–MS. Understanding CDS features — method templates, sequence tables, audit trails, validation, data processing algorithms, 21 CFR Part 11 compliance, electronic signatures, calibration, system suitability and data integrity — bridges theory and regulated laboratory practice. Mastery of CDS improves accuracy in peak identification, retention time reproducibility, and quantitation using internal/external standards. Practical knowledge of CDS is critical for pharmaceutical analysis, quality control and regulatory submission. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary function of a Chromatographic Data System (CDS)?
- Control laboratory HVAC systems
- Manage chromatographic instruments and process chromatographic data
- Design new chemical compounds
- Perform mass spectrometer hardware maintenance
Correct Answer: Manage chromatographic instruments and process chromatographic data
Q2. Which CDS feature ensures reproducible processing across samples and runs?
- Sequence table
- Method template
- Instrument calibration sticker
- Laboratory notebook
Correct Answer: Method template
Q3. In quantitative chromatography, which CDS output is most commonly used for calculating analyte concentration?
- Peak area
- Retention time
- Baseline noise
- Detector lamp intensity
Correct Answer: Peak area
Q4. Which integration parameter in CDS helps discriminate peaks from baseline noise?
- Slope sensitivity (or threshold)
- Injection volume
- Mobile phase composition
- Column oven temperature
Correct Answer: Slope sensitivity (or threshold)
Q5. What does 21 CFR Part 11 primarily regulate with respect to CDS?
- Chemical structures
- Electronic records and electronic signatures
- Chromatographic column dimensions
- Manual titration procedures
Correct Answer: Electronic records and electronic signatures
Q6. Which CDS function provides traceability of who changed a method or result?
- Audit trail
- Autosampler
- Peak detector
- Injection needle
Correct Answer: Audit trail
Q7. For system suitability, which CDS-calculated parameter indicates column efficiency?
- Theoretical plates (N)
- Retention time (tR)
- Peak width at base
- Detector wavelength
Correct Answer: Theoretical plates (N)
Q8. Which CDS feature helps automate sequences of injections with different samples and standards?
- Sequence table
- Baseline correction
- Peak smoothing
- Calibration curve
Correct Answer: Sequence table
Q9. What is the purpose of retention time locking in CDS workflows?
- Fix column temperature to ambient
- Maintain consistent retention times across systems and batches
- Disable detector signals
- Increase sample injection volume
Correct Answer: Maintain consistent retention times across systems and batches
Q10. Which algorithm is commonly used in CDS for smoothing chromatographic peaks?
- Savitzky–Golay filter
- Fourier transform infrared
- Monte Carlo simulation
- Simple linear regression
Correct Answer: Savitzky–Golay filter
Q11. In CDS, peak purity assessment is most useful for detecting:
- Column dead volume
- Co-eluting impurities within a peak
- Autosampler leaks
- Instrument firmware version
Correct Answer: Co-eluting impurities within a peak
Q12. Which CDS report element is critical for regulatory submissions to show calculated results and method details?
- Result report with method and audit trail
- Laboratory floor plan
- Unused reagent inventory
- Employee payroll sheet
Correct Answer: Result report with method and audit trail
Q13. Which calibration approach in CDS uses an internal reference compound added to every sample?
- Internal standard calibration
- External standard calibration
- Standard addition without reference
- Blank subtraction method
Correct Answer: Internal standard calibration
Q14. What CDS setting adjusts how peaks are separated from the baseline when they overlap slightly?
- Peak deconvolution or valley definition
- Autosampler tray size
- Mobile phase pH
- Detector lamp alignment
Correct Answer: Peak deconvolution or valley definition
Q15. Which CDS validation activity confirms the software performs correctly for intended use?
- System validation (IQ/OQ/PQ)
- Daily column cutting
- Reagent expiry labeling
- Employee orientation
Correct Answer: System validation (IQ/OQ/PQ)
Q16. What is the main advantage of using a diode-array (DAD/PDA) detector with CDS?
- Simultaneous multi-wavelength spectra and peak purity analysis
- Higher injection volumes
- Lower mobile phase consumption
- Reduced column backpressure
Correct Answer: Simultaneous multi-wavelength spectra and peak purity analysis
Q17. Which CDS security control limits system access and enforces user responsibilities?
- User accounts and role-based permissions
- Column oven temperature control
- Autosampler needle length
- Chromatographic buffer pH
Correct Answer: User accounts and role-based permissions
Q18. LOD and LOQ in CDS-derived results are typically determined from:
- Signal-to-noise ratio or calibration statistics
- Column dimensions only
- Manufacturer warranty
- Detector power supply voltage
Correct Answer: Signal-to-noise ratio or calibration statistics
Q19. In CDS, what does baseline correction accomplish?
- Removes drift and offsets to accurately integrate peaks
- Increases sample throughput
- Calibrates the autosampler motor
- Changes mobile phase composition automatically
Correct Answer: Removes drift and offsets to accurately integrate peaks
Q20. Which CDS capability assists in comparing an unknown peak spectrum with a library for identification?
- Spectral library search (e.g., UV or MS library matching)
- Autosampler cooling
- Manual pipetting guide
- Column packing instructions
Correct Answer: Spectral library search (e.g., UV or MS library matching)
Q21. Which CDS output is most sensitive to changes in injection volume when quantitating by peak height?
- Peak height
- Retention time
- Mobile phase temperature
- System pressure limit
Correct Answer: Peak height
Q22. What is a common reason to reprocess chromatographic data in a CDS?
- To apply updated integration parameters or correct processing errors
- To change the physical column hardware
- To alter reagent lot numbers on raw data files
- To increase the lab room temperature
Correct Answer: To apply updated integration parameters or correct processing errors
Q23. Which CDS practice helps ensure long-term data integrity and recoverability?
- Regular data backup and archival with validated procedures
- Leaving instruments powered off overnight
- Handwritten backup of chromatograms
- Using non-validated USB drives without control
Correct Answer: Regular data backup and archival with validated procedures
Q24. What is the role of system suitability tests in a CDS-controlled chromatographic run?
- Verify the system is performing acceptably before sample analysis
- Increase sample injection speed
- Reduce detector sensitivity permanently
- Calibrate room lighting
Correct Answer: Verify the system is performing acceptably before sample analysis
Q25. Which CDS parameter indicates peak symmetry and is important for method validation?
- Tailing factor
- Autosampler injection speed
- Mobile phase color
- Column brand name
Correct Answer: Tailing factor
Q26. In CDS quantitative methods, a calibration curve with r^2 close to 1 indicates:
- Good linearity between response and concentration
- Poor instrument maintenance
- High baseline noise only
- Incorrect chromatographic column
Correct Answer: Good linearity between response and concentration
Q27. Which CDS feature helps detect and log changes to raw data or result files after initial creation?
- Audit trail and electronic signatures
- Column temperature gradient
- Mobile phase degasser
- Detector lamp intensity monitor
Correct Answer: Audit trail and electronic signatures
Q28. When coupling LC to MS, what CDS capability is particularly important?
- Instrument control and synchronization with MS data acquisition
- Manual peak labeling by pen
- Increased oven capacity
- Photographic documentation of columns
Correct Answer: Instrument control and synchronization with MS data acquisition
Q29. Which CDS processing technique can separate overlapping peaks by mathematical fitting?
- Peak deconvolution or curve fitting
- Increasing detector voltage
- Changing the user password
- Altering room humidity
Correct Answer: Peak deconvolution or curve fitting
Q30. During method validation in a CDS, which test assesses repeatability of results under the same conditions?
- Precision (repeatability)
- Robustness to pH changes
- Forced degradation study
- System suitability failure
Correct Answer: Precision (repeatability)
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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