Pharmaceutical analysis = is a broader term which can be defined in many
ways. It is the series of processes that are used for identification, determination,
separation, purification, and structure elucidation of the given compound used
in the formulation of pharmaceutical products.
it is a method used to determine a chemical or physical
property of a chemical substance, chemical element, or
There is a wide variety of techniques used for analysis, from
simple weighing to advanced techniques using highly
spectrophotometer is a technique used to
measure light absorbance across the
ultraviolet and visible ranges of the
In a double beam UV visible spectrophotometer, only light of
a specific wavelength is extracted from the double beams or
resulting spectrum. The light rays are extracted from the exit
slit opening of the spectrophotometer device. The
monochromatic light intensity irradiates the samples and
intensity is detected.
The double beam spectrophotometer uses an infrared
thermometer and photometers to measure absorbance
versus wavelength to detect the color of the sample. The
absorbance measurement is the ratio of the sample to the
Calibration determines that a device or
instrument is producing accurate results
within the specified limits compared to those
produced by a traceable standard.
Validation is the procedure which authorizing documentary
evidences that prove, the following process/ method or
activity will consistently produce the product which leads to
the expected result (predetermined requirements).
Types of validation:
INTRODUCTION- Flame photometry is defined as the
measurement of intensity of the light emitted when any
alkali or earth metal is introduced into the flame. Because
of the emission of radiation, it is also known as
flame emission spectroscopy.
Flame Photometry works by measuring the intensity of light emitted
(measured using a wavelength of a colour ) when the element is
exposed to a Flame. Flame Photometer Components: There are four
basic components to a Flame Photometer– a flame, nebulizer and
mixing chamber, colour filters, and a photo detector.
The photometers have to be calibrated to get a correlation between
signal and concentration or to compare readings among different
photometers. Therefore a method must be established that produces
a stable and reproducible readout.
A pH meter is an instrument used to measure acidity or
alkalinity of a solution - also know as PH. PH is the unit of
measure that describes the degree of acidity or alkalinity.
A PH meter works by measuring the electrical potential
(voltage) produced by the solution being tested, using the
potential difference to determine the PH.
A pH calibration is the process of adjusting your pH meter by
measuring solutions of a known PH value. This is because the
characteristics of your electrode will change over time and this needs
to be compensated for. A calibration does this by matching your pH
meter to the current characteristics of your pH sensor.
Regulatory Guidelines means applicable
rules, guidance, manuals, protocols, codes,
guidelines, treaties, policies, notices,
directions, decrees, judgments, awards or
requirements, in each case of any
Regulatory Authority to the extent that the
foregoing do not have the force of law.
The term quality control refers to the sum of
procedures undertaken to ensure the identity
and purity of a particular pharmaceutical
Quality Assurance (QA) activities include a
planned system of review procedures
conducted by personnel not directly involved
in the inventory development process.
Good Laboratory Practices is a
quality system concerned with
the organizational process
and the conditions under
which a study is planned,
performed , monitored,
recorded, archived and
2 Analytical validation
5 Qaulity of Biotechnological product
8 Pharmaceutical Development
9 Quality Risk Management
10 Pharmaceutical Qaulity System
11 Development And Manufacture Of Drug Substances
12 Lifecycle management
13 Continuous Manufacturing Of Drug Substances And Drug Product
14 Analytical Procedure Development
In this review attempt is made to incorporate
various analytical instruments and their principle
with their detail instrument analytical Instruments
like i.e. Ultraviolet spectroscopy, flame
photometer, PH meter, They are used often
because of its speed,simplicity and availability. It
has applications in various chemical and drug
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