Introduction to Pharmaceutical Analysis Flashcards by San Felipe Michael Josh

Methods for determining the chemical composition of samples of matter

Analytical Chemistry

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yields information about the identity of
atomic or molecular species or the functional groups in the sample

Qualitative Method

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provides numerical information as to the
relative amount of one or more of these components.

Quantitative MEthod

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The process of a quantitative determination of a
chemical substance from a given sample

Asay

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Types of Method of Drug Analysis

Nature of Sample
Size of Sample
Extent of Analysis

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What is the classifications of nature of sample

Physical
Chemical
Biological

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Instruments, Device

Physical

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Reagents, Compounds, substances

Chemical

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Living organisms, urine, animals, microorganisms

Biological

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What are the classifications of Size of Sample?

Macroanalysis
Semi-microanalysis
Microanalysis
Submicroanalysis
Ultramicroanalysis

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0.1 g or more

Macroanalysis

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0.1 g - 1 g

Semi-microanalysis

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0.01 g - 0.1 g

Microanalysis

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0.001 g - 0.01 g

Submicroanalysis

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<0.001 g

Ultramicroanalysis

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The sum of total of the organised arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and quality systems are maintained

Quality Assurance

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Checking or testing that specifications are met
(PIC/s cGMP 2018)

Quality Control

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Ensures the safety, efficacy, stability and purity
of raw materials and drug products.

Quality Control

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• identification, determination, quantification and
purification of a substance;
• separation of the components of a solution or
mixture; or
• determination of structure of chemical compound

Pharmaceutical analysis

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analysis of raw materials active pharmaceutical ingredients (APIs), intermediates, excipients, pharmaceutical substances and finished products

Pharmaceutical Analysis

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Classification of Analytical Methods of Techniques

Separation
Qualititative Analysis
Quantitative Analysis

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What are the classical methods of separation techniques

Precipitation
Extraction
Distillation

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What the classical methods of Qualititative analysis

Chemical tests
B.P.
M.P
Solubility
Odor,
Optical activitt
Refractive index

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What is the classical methods of the technique quantitative analysis

Titrimetry, Gravimetry, Coulometry

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what are the instrumental methods of separation techniques

Chromatography, electrophoresis

what are the instrumental methods of the technique quantitative analysis

UV/Vis spectrometry, infrared spectrometry, MS, NMR spectrometry

what are the instrumental methods of quantitative analysis

Potentiometry, voltammetry, spectrophotometry, AAS, thermometric methods, kinetic methods

Securing or getting a representative sample from a given population

Sampling

what are the two types error

Indeterminate Determinate

Aka Random Error

indeterminate

Uncontrolled variable

Indeterminate

inherent error

indeterminate

Intangible

Indeterminate

Systematic Error

Determinate error

Flaw in the equipment or design of the experiment

Determinate error

Reproducibility of the result

Precision

Usually expressed as average deviation, standard deviation or range.

Precision

difference between the largest and smallest value.

Range

describes how close a measured value is to the “true” value

accuracy

Difference between the mean value and true value

Absolute Error

Absolute error divided by the true value

Relative Error

Enumerate the classical method of trimetry

Neutralization Redox Complexation Volumetric Precipitation

Enumerate general or classical mehods

Trimetry Gravimetry

a volume of a solution of known concentration consumed during analysis is taken as a measure of the amount of active constituent in a sample being analysed

Titration

measuring the volume of known concentration needed to react with analyte

Volumetric Titrations

Mass instead of volume

Gravimetric Titrations

measure time require for complete electrochemical reaction

Coulometric Titrations

standard solution of known concentration

Titrant

substance to be determined

analyte

Organic substances (acids/bases) capable of existing in two forms of different color depending on the pH

Indicator

Theoretical point reached when the titrant and analyte are chemically equivalent

Equivalence Point

When a physical change occurs that is associated with the condition of chemical equivalence

End point

weight of the substance chemically equivalent to 1mL of a standard solution.

Titer

Weight of a substance in gram that is chemically equivalent to 1 gram-atom of hydrogen.

Gram-equivalent weight

Titrant is directly added to analyte until the reaction goes to completion

Direct Titration

addition of excess titrant, the volume of which that did not react with the analyte is then titrated (residual or back titration)

Residual Titration

Objectives • To find out the effect of the impurities • To determine the excess standard solution necessary to establish the end-point

Titration with Blank Test

enumerate other types of titration

Indirect Titration Double Residual Titration

What are some detection methods

Visual Instrumental

Appearance/Disappearance of color

Visual

Change in color

Visual

Appearance and disappearance of turbidity

Visual

Colorimeters, turbidimeters, spectrophotometers

Instrumental

Potentiometer

Instrumental

for general industrial use

technical grade/commercial

chemicals manufactured under current GMP and which meet the requirement of USP/NF

USP/NF

high quality chemical for laboratory use (Reagent A.C.S. – American Chemical Society)

Analytical

products of purity suitable for use in general applications

Chemically pure

analytical reagent of exceptional purity that is specially manufactured for standardizing volumetric solutions and preparing reference standards.

Primary Standard grade

What are the grades of reagents?

Technical Grade/Commerical USP/NF Analytical Chemically pure Primary Standard grade

Determination of exact concentration (Normality or Molarity) of a solution

Standardization

• Highly purified compound • Serves as a reference material for a titration and in other analytical methods • Used to standardize the volumetric solutions (VS)

Primary Standard

• Purity has been determined by chemical analysis • Serves as the working standard material for titrations and for other analyses • Concentration is subject to large uncertainty against 1O standard

Secondary Standard

What are concentration Expressions?

Molarity Normality Percent Strength

MW divided by the number of electrons shared by atoms in a molecule (TOTAL POSITIVE CHARGE)

Equivalent Weight

Introduction to Pharmaceutical Analysis Flashcards

(75 cards)