BP & Pharmaceutical analysis + Measurement and Data reliability Flashcards
What is in a monograph?
description of the product, identification tests, physical constants, minimum purity standards & Assay of API, limit test and storage conditions
What information can you get from pharmaceutical analysis?
Drug ID & purity, shelf life, impurities ID and concentrations
What is the BP?
Provides authoritative official standards for pharmaceutical substances and medicinal products. It has monographs that contain tests that provide verification of the suitability/ identification and quantification of impurities
Quantities taken for assay must not deviate by what percentage?
10%
Visual comparative tests are conducted in what type of tube?
flat base tubes called Nessler cylinders
What are the basic steps involved in sample analysis?
extraction, purification, characterisation and data validity
How would you take a measurement on a digital instrument vs a scaled instrument?
digital you take reading as displayed and scaled you go one more significant figure than you can read
What is the difference between a random, systematic and gross error?
a random error is due to chance and not standardized and decreases precision, whereas a systematic error shifts all measurements in a standardised way and decreases accuracy, and gross error is a big mistake usually made during measuring, observations and calculation.
How do you evaluate accuracy and precision from a set of measurements?
for precision you calculate range and SD/RSD and for accuracy you calculate the absolute error or relative error
What are the 3 origins of systemic errors?
instrumental, method or personal error
What is precision?
a measure of how close a series of measurements are to each other
What is accuracy?
how close measurement is to the accepted/true value