Pharmaceutical analysis

 Pharmaceutical analysis

Pharmaceutical analysis is
a branch of practical chemistry that involves a series
of process for identification, determination, quantification and purification of
a substance, separation of the components
of a solution or mixture, or determination
of structure of chemical compounds.


The substance may
be a
single compound or a mixture of compounds
and it may be in any of
the dosage form. 

substance used as pharmaceuticals are animals, plants, microorganisms, minerals
and various synthetic products.


The different pharmaceutical
agents are as follows:


1.         Plants


2.         Microorganisms


3.         Minerals


4.         Synthetic


Pharmaceutical analysis is traditionally defined as analytical chemistry dealing with drugs both as bulk drug substances and as pharmaceutical products (formulations). 

However, in academia, as well as in the Pharmaceutical Industry. other  branches of analytical chemistry
are  also  involved,  viz.
 bioanalytical  chemistry,
 drug metabolism studies

The development of drugs 
in the pharmaceutical industry is 
a longterm process, often taking more than a
decade from the
start of a research
project to
of a
rug on the market. 

That process involves several decision points, such as the choice of the candidate
drug after the preclinical screening phase, the investigational new drug
(IND) application before testing the compound
for the first time in man, and finally the new drug
application (NDA) which summarizes the data
obtained from all the studies needed for
marketing approval of the drug as a medicine. 

In all these steps,
especially the IND and
NDA, the amount of data generated
is enormous. 

Analytical chemists take part in many of the studies that constitute this documentation. 

Substance quality and its specifications are based
substance analysis, and that knowledge is later used for quality control during fullscale production. 

Product analysis involves dealing with the various formulations and starts after
IND has been approved. 

results from such work lead to specifications that form the
asis for the quality
control of the product. 

For both substances and formulations there is an increasing interest
in the introduction of process analytical chemistry.


The sample
to be analysed
is called as analyse.


    Quality control and
quality assurance

    Chromatographic techniques

    Quantitative and
qualitative analysis

    Validation methods

    Stoichiometry between reactants
& products

Scope of Pharmaceutical Analysis

Pharmaceutical Analysis is one of the most sort after specializations in masters of

People specialised  in  pharmaceutical
 analysis  are  indispensable to  the manufacturing,
quality control
and analytical manifestations of the industry.

They can work in quality control
department which oversees the purity, qualitative aspects and the matching of the stringent regulatory limits required by a finished product.

Research and development has huge implications on the results of the analysis and
detection of new compounds. More and more companies are stressing on a separate analytical R&department.

Pharmaceutical analysis students also find takers in the medical devices companies,
equipment companies, regulatory agencies etc.

Always remember, no matter what compounds
you discover or formulation you make
nothing is valid until it is evaluated, analysed

Based upon the determination type, there are mainly two types of analytical methods.


They are as follows:

Qualitative analysis:




1. Qualitative analysis

This method is used for
the identification of the
compounds. Qualitative analysis is
performed to establish composition of natural/synthetic substances.
These tests are performed to indicate whether the substance or compound
is present in the sample or not.


2. Quantitative analysis

This method is used for the determination
of the amount of the
sample. Quantitative analytical techniques
are mainly used to quantify any compound or
substance in the sample.
There are various
methods to find out the quantity of a substance in
a product.


Various types of Qualitative

1.Chemical methods

a) volumetric or titrimetric

b) gravimetric

c) gasometric



4.Biological and microbiological

Methods of
Expressing Concentration of Solution


Concentration of solution is the amount of solute dissolved
in a
known amount of the solvent
or solution. The concentration of solution
be expressed in various ways as discussed


Percentage: It refers to the amount of the solute per 100 parts of the solution. It can also
be called as
parts per hundred (pph). It can be expressed by any of following
four methods,


to weight

% w/w =     
 Wt of solute   x 100


Wt of solution

Weight to
volume percent

% w/v =     
 Wt of solute  x


Volume of solution

Volume to
volume percent

% v/v=       Volume of solute   x

Volume of solution

(iv)Volume to
weight percent


% v/w =     
 Volume of solute   x

                        Wt of solution


(2) Parts per million (ppm)
and parts per billion (ppb):


When a solute is present in trace quantities, it is convenient to express the concentration in parts per million and parts per billion. It is the number of parts of solute per million
1) or per billion (109) parts
of the solution. It
is independent of the temperature.

of solute component

                    Total mass of solution


Ppb=     mass
of solute component
   x 10

               Total mass of solution


(3) Normality (N)


It is defined as the number
of gram equivalents (equivalent weight in grams) of
a solute present per litre of the solution. Unit of normality is gram equivalents litre
–1. Normality
changes with temperature since it involves volume. When a solution is diluted

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