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Pharmaceutical Analysis & QC Instrumental Methods

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#1 Advanced Level

Beer-Lambert’s Law (A = ε·c·l) shows a linear relationship between absorbance and concentration. At what absorbance level does severe deviation from linearity typically begin due to stray light and detector saturation?

A. A > 0.01 B. A > 0.2 C. A > 1.5 to 2.0 D. Beer's law has no upper limit

#2 Intermediate Level

In reverse-phase high-performance liquid chromatography (RP-HPLC), what are the standard characteristics of the stationary phase and mobile phase?

A. Stationary phase is polar (e.g. Silica); mobile phase is non-polar (e.g. Hexane) B. Stationary phase is non-polar (e.g. C18 / Octadecylsilane); mobile phase is polar (e.g. Water/Methanol/Acetonitrile) C. Both stationary and mobile phases must be gaseous D. Stationary phase is an ion-exchange resin; mobile phase is pure ether

#3 Intermediate Level

According to the United States Pharmacopeia (USP), what is the acceptable range for the HPLC "Tailing Factor (T)" for an analyte peak?

A. Between 0.1 and 0.5 B. Between 0.95 and 1.5 (or <= 2.0 depending on monograph) C. Exactly 0.00 D. Greater than 3.5

#4 Intermediate Level

Under ICH Q2(R1) validation guidelines, which parameter measures the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogeneous sample?

A. Specificity B. Precision (Repeatability / Intermediate Precision) C. Accuracy (Trueness) D. Robustness