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Industrial training report rajeev

Philosophy (University of Delhi)

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A
Report on

Industrial training
Submitted by
NAME- Rajeev Kumar Singh
Roll No-19BPH061
Class-B.Pharma (7thsem)

In partial fulfilment of the requirement for the Degree of

Bachelor of pharmacy

Submitted to
GOPAL NARAYAN SINGH UNIVERSITY BIHAR

Narayan institute of pharmacy

Jamuhar, Bihar-821305

Academic year: 2022-2023

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DECLARATION
I Rajeev Kumar Singh, hereby declare that work presented in the
industrial training report entitled in industrial training performed at sun
pharmaceutical industrial ltd, sarhaul, sector-18, gurugram-
122015(Haryana).
It is an authentic record of work carried out by me during
29.08.2022 to 29.09.2022 at sun pharmaceutical industries ltd. Under the
guidance of Gopal narayan Singh university jamuhar, sasaram (Bihar). Is
being submitted for partial fulfillment of the requirement for the award
of bachelor degree in B.pharma.

RAJEEV KUMAR SINGH

PLACE- NARAYAN INSTITUTE OF PHARMACY

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AKNOWLEDGEMENT
I consider it a grant privilege & honor to have had the opportunity to
under the industrial training work in sun pharmaceutical industrial ltd.
Hence, I would like to offer my heartiest thanks to Mr. amok ranjan
prabhat (HR).

I am greatly indebted to Dr Dharmendar Kumar (principle), Mr. Vedanta

prajapati assistant professor, Narayan institute of pharmacy, for
enabling us to have chance of industrial training and arranging such a
nice arrangement.

I convey my heartiest thanks to Dr. Ayash panda (QA Head), Mr.

Santosh shiriwasto (QA), for their most valuable suggestions, constant
encouragement and affectionate guidance during the period of this
training.

I owe gratitude Mr. Alok sir for their support and guide to carry out the
task assigned to us while in the training; at last I am greatly thankful to
all my seniors and collageous in sun pharmaceutical industrial ltd.for
extending their constant cooperation which went a long way towards
the completion of this training report.

Thanking you
Rajeev Kumar Singh

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PREFACE
Pharmacy is a profession which is concerned with the art and science of
preparing suitable and convenient material for distribution and use in the
treatment and prevention of disease, so it is fully technical profession
where practical knowledge much important along with theoretical
knowledge.
According to curriculum of a four year integrated degree course of
BACHELOR OF PHARMACY each student has to undergo practical
training for a period of one month in various pharmaceutical industries
in India.
I was directed the 4th year training at SUN PHARMACEUTICAL
INDUSTRIAL LTD. And this report contains a brief description of the
above pharmaceutical industry which was observed during the training
program.

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OJECTIVE OF INDUSTRIAL TRAINING

The purpose of Industrial Training is to expose student to real work of
environment experience and at the same time to gain the knowledge
through hands on observation and job execution. From the industrial
training, the students will also develop skills in work ethics,
communication, management and others. Moreover, this practical
training program allows students to relate theoretical knowledge with its
application in the manufacturing industry.

The objectives of industrial training are:

* To provide students the opportunity to test their interest in a particular
career before permanent commitments are made.
* To develop skills in the application of theory to practical work
situations.
* To develop skills and techniques directly application to their careers.
* I internships will increase a student’s sense of responsibility and good
work habits.
* To expose students to real work environment experience, gain
knowledge in writing report in technical works/projects.
* Internship student will have higher levels of academic performance.
* Internship program will increase student earning potential upon
graduation.

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CONTENTS
1. Quality assurance department:
 Introduction
 Objective
 Responsibilities of QA
2. Validation:
 Introduction
 Types of validation
 Parameters
3. Sop for review analytical report and raw data:
 Purpose
 Scope
 Responsibilities
 Analytical raw data/ report reviewer shall be
responsible for:
4. Quality control Department:
 Quality control sampling section:
 Quality control chemical section:
 Quality control microbiology section:
 Quality control office:
 Review process and observation Reporting.
5. Instrumental method:
 GC
 HPLC
 NMR
 XDR
 UV visible

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QUALITY ASSURANCE
Quality assurance is process to become assure regarding the quality of
any manufacturing product. In this process we compare the quality of
finished product with its pre-design sample. This is an important step
for the satisfaction quality.

Objective of quality assurance:-

Enhance efficiency of product.
Assuring the quality of raw material.
Assuring the quality of finished product.
Managing good laboratory practices (GLP).
Managing good manufacturing practices (GMP).

RESPOSIBILITIES OF QA:-
Ensuring proper warehousing practice.
Manufacturing process and process check.
Both record review.
QA is responsible for stability testing and self life evaluation.
Deviation is reported, investigated and record.
Arrangement is made for the manufacture, supply and use of correct
starting and packaging material.
QA is responsible for making the master plan for entire process.

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VALIDATION
Introduction:-
The validation process is the documented evidence which
provides a high degree of assurance to a desired result with
predermined compliance. The term validation is widely used in
pharmaceutical industries. This term comes from the word “valid
or validity” which means “legally defined”. The validation concept
was first proposed by the Food and Drug Administration (FAD) in
the mid-1970s to improve the quality of pharmaceutical products.
Since a wide variety of procedures, methods or activates are
validated to check and improve their quality.

Types of validation:-
Validation is divided into following subsections which include:
1. Analytical method validation
2. Process validation
3. Cleaning validation
4. Equipment validation

1. Analytical method validation: The purpose of analytical

validation is to verify that the selected analytical procedure will
give reliable results that are adequate for the intended purpose.
There are different parameters which come under analytical
method validation. These are as follows:
 Accuracy
 Precision
 Repeatability

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 Reproducibility
 Specification
 Linearity
 Range
 Detection limit
 Quantitation limit

2. Process validation: This type of validation demonstrates

documented proves, which carries a higher degree of surety
that the process will consistently produce a product which
meets all the predetermined quality characteristics and
specifications. The process validation also assures the
repeatability of the process and decreases the risk of
manufacturing problems which lead to an increase in output of
predetermined quality.
On the bases of the stage of production under process
validation, it can be of four types which are as follow:
 Prospective validation
 Concurrent validation
 Retro specific validation
 Revalidation.

3. Cleaning validation: Cleaning validation provides documented

set up with a high degree of surety that particular
system/equipment or part of equipment is consistently clean-up
to predetermined quality and acceptable limits. Pharmaceutical
products are contaminated by variety of substances such as
lubricants, airborne materials, prepared product residues, and
microbes. Hence, an adequate cleaning procedure plays an

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important role to prevent contamination and cross

contamination.

4. Equipment validation: Equipment validation is established

documented set up that proves any equipment works correctly
and leads to accepted and accurate results (predetermined
result). The process of equipment validation is based on the
principle that equipment must be designed, constructed,
maintained, and adapted to perform the operations which are
to be carried out. Equipment’s are the basic component of
pharma industries; therefore, before performing a process in
pharma industries, it becomes primary important to issue
equipment validation (documented evidences of equipment).

Parameters to be checked for method validation:-

 Selectivity/specificity
 Precision
 Accuracy
 Linearity
 Range
 Stability
 Limit of detection(LOD)
 Limit of quantitation(LOQ)
Selectivity/specificity:- Selectivity of an analytical method is its
ability to measure accurately an analyte in the presence of
interferences that may be expected to be present in the sample matrix.
Selectivity is checked by examining chromatographic blanks (from a

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sample that is known to contain no analyte) in the expected time

window of the analyte peak. And the raw data for selectivity will be
recorded in the raw data in approved formats.

Precision:-
Precision of a method is the degree of agreement among individual
test results when the procedure is applied repeatedly to multiple
samplings. Precision is measured by injecting a series of standards or
analyzing series of samples from multiple samplings from a
homogeneous lot. From the measured standard deviation (SD) and
Mean values, precision as relative standard deviation (% rsd) is
calculated.

Accuracy:-
The accuracy of an analytical method is the degree of agreement of test
results generated by the method to the true value. Accuracy is
measured by spiking the sample matrix of interest with a known
concentration of analyte standard and analyzing the sample using the
“method being validated.” The procedure and calculation for Accuracy
(as% recovery) will be varied from matrix to matrix and it will be given
in respective study plan or amendment to the study plan.

Range:- The range of an analytical method is the interval between the

upper and lower levels that have been demonstrated to be determined
with precision, accuracy and linearity using the set method. This range
will be the concentration range in which the Linearity test is done.

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Linearity:-
The linearity of an analytical method is its capability to elicit check
consequences which might be at once, or with the aid of well described
mathematical adjustments, proportional to the concentration of
analytes in within a given range. Linearity is determined by injecting a
series of standards of stock solution/diluted stock solution using the
solvent/mobile phase, at a minimum of five different concentrations in
the range of 50–150% of the expected working range. The linearity
graph will be plotted manually/ using Microsoft Excel or software of the
computer (Concentration vs. Peak Area Response) and which will be
attached to respective study files.

Stability:-
Many analytes readily decompose prior to chromatography
investigations, for example during the preparation of the sample
solutions, during extraction, clean-up, phase transfer, and during
storage of prepared vials. Under these circumstances, method
development should investigate the stability of the analyte. Accuracy
test takes care of stability. It is required to mention in the method how
long a sample after extraction can be stored before final analysis, based
on the duration taken for accuracy test.

Limit of detection (LOD) and limit of quantitation:-

The term LOD is defined as the lowest concentration at which the
instrument is able to detect but not quantify and the noise to signal
ratio for LOD should be 1:3. The term LOQ is defined as the lowest
concentration at which the instrument is able to detect and quantify.
The noise to signal ratio for LOQ should be 1:10. Determination of Limit

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of Detection (LOD) and Limit of Quantitation (LOQ) from Detector

Linearity experiments (applicable to only instrument sensitivity). LOD
and LOQ values are calculated manually by taking Noise to signal ratio
of a lowest/ known concentration of linearity samples and it will be
expressed in μg/ml or ppm. To calculate in %, values of LOD and LOQ
will be multiplied by 100/lowest or known concentration of test item
(mg/L) taken for analysis of that particular a.i. or impurity analysis.

Calculations of LOD and LOQ values for instrument sensitivity:

𝑛𝑜𝑖𝑠𝑒
LOD(mg/L)= 3 × × 𝐿𝑜𝑤𝑒𝑠𝑡 𝑐𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛 𝑜𝑓 𝑡ℎ𝑒 𝑙𝑖𝑛𝑒𝑎𝑟𝑖𝑡𝑦 𝑠𝑎𝑚𝑝𝑙𝑒s
𝑠𝑖𝑔𝑛𝑎𝑙

𝑛𝑜𝑖𝑠𝑒
LOQ(mg/L)= 10 × × 𝑙𝑜𝑤𝑒𝑠𝑡 𝑐𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛 𝑜𝑓 𝑡ℎ𝑒 𝑙𝑖𝑛𝑒𝑎𝑟𝑖𝑡𝑦 𝑠𝑎𝑚𝑝𝑙𝑒𝑠
𝑠𝑖𝑔𝑛𝑎𝑙

Calculation of LOD and LOQ values for method:

𝑳𝑶𝑫(𝒎𝒈|𝒍)
LOD(%)= × 𝟏𝟎𝟎
𝒕𝒆𝒔𝒕 𝒊𝒕𝒆𝒎 𝒄𝒐𝒏𝒄.𝒖𝒔𝒆𝒅 𝒇𝒐𝒓 𝒒𝒖𝒂𝒏𝒕𝒊𝒇𝒊𝒄𝒂𝒕𝒊𝒐𝒏

𝑳𝑶𝑫(𝒎𝒈|𝒍)
LOQ(%)= × 𝟏𝟎𝟎
𝒕𝒆𝒔𝒕 𝒊𝒕𝒆𝒎 𝒄𝒐𝒏𝒄.𝒖𝒔𝒆𝒅 𝒇𝒐𝒓 𝒒𝒖𝒂𝒏𝒕𝒊𝒇𝒊𝒄𝒂𝒕𝒊𝒐𝒏

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Sop for Review analytical report and raw data

Analytical raw data is data generated during sample analysis and
include traceability of equipment and reagents used for analysis e.g.
name of the material, instrument ID, template, chromatograms
(electronic and hard copy) , the potency of reference standard/
working standard reagent, calculations, results, COA, etc.

1. Purpose:
The purpose of this sop to describe the procedure for review of the raw
data of analysis carried out in the quality control laboratory.

2. scope:
this sop is applicable to quality control laboratory of pharmaceutical
manufacturing plant for:

 Analysis and reporting.

 Review process and observation reporting
 Observation compliance
 Observations trend analysis.

Responsibilities:
Quality control analyst shall be responsible for:

 Perform the analysis as per the approved

specification/ATP/protocol.
 Report the analytical raw data and submit for review as per the
respective sop.
 To give the proper cross-reference for each test in case the test
results of a specific batch is filed with any other report (i.e. other

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batch no. or A.R.no.) for identification and easy tracing /tracking

of data during the review.
 Submit an analytical report/raw data after completion of analysis
along with all supporting data to section head /reviewer for
review.
 To correct the observations given by the reviewer.
 To report any event /lab event, incident, deviation, oos, ooc, oot,
etc. to the head QC or designee.

Analytical raw data / report reviewer shall be responsible for:

 Review the analytical raw data for adequacy and accuracy, as per
(but not limited to) the checklists.
 Provide the on-job training to the analyst as per requirements.
 To ensure the adequacy of compliance for the observations.
 Ensure handing of event/lab/event, incident, deviation, oos, ooc,
oot, etc. as per the respective sop.

The technical person from Quality Assurance department shall

be responsible for:-
 To check the sop.
 Ensure the implementation of the system as per the sop.
 Review the paper and electronic raw data and records generated
in the QC laboratory as a secondary check by QA.

Review process and observation reporting:

 Raw data of any analysis shall be reviewed within two working
days from completion of the analysis.

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 After verification of raw data/ analytical reports, the analyst shall

submit the analytical report to the reviewer with all supporting
data for review.
 The reviewer shall review all the tests/results against current
practices, sop, specification and ATP.
 Verify correct reporting of raw data, calculation and cross-
reference and details(Batch no./potency and expiration dates of
reference standard/impurity standard/ working standard, make/
grade and validity of reagent’s/ buffer’s/indicator solution,
instrument calibration expiration dates, etc) given in raw
data/hard book of respective tests.
 Ensure the proper traceability of document, analyst’s signature
and results reporting, cancellation of blank space in raw data/
hard book with proper justification and also check for any
relevant additional attachments attached.
 Reviewer shall check the entries in the logbooks of instrument
and equipment used for analysis and shall verify the calibration/
qualification status at random and it should be in chronological
order of activities.
 Use only Ballpoint pen for signing the logbooks, checking the
analytical raw data, analytical worksheets, and issuance of
Annexures and attachments of the sop.

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QUALITY CONTROL DEPARTMENT

1. Quality control sampling section:
Responsibilities:-
 To draw the sample of RM from store.
 To draw the samples of F.G. from production department.
 To keep control sample for reference & for stability studies.
 Final inspection of each batch.
2. Quality control chemical section:
Responsibilities:-
 Complete analysis of all RM/ process & F.G. sample as per prescribed
standard.
 To send report to production, store, QC office.
 To carry out stability testing etc.
 Instrument maintenance and calibration.
3. Quality control microbiology section:-
Responsibilities:-
 Microbiological analysis of RM/process/FG/sample.
 To send report to production, store, QC office.
 Quality control packing material test.
 To carry out stability testing.

Quality control office:-

Responsibilities:-
 To make certificate of analysis of RM &finished product.
 To maintain &keep recorded of analysis & certificate of analysis.

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INSTUMENTAL METHODS
GAS CHROMATOGRAPHY (GC):-
Gas chromatography is a type of chromatography which is used to
separate and analyze compounds that can be vaporized without
decomposition.

Types of GC:-

1. Gas solid chromatography

2. Gas liquid chromatography

1. Gas solid chromatography:-

 In this type the mobile phase is gas and stationary phase is solid.

2. Gas liquid chromatography:-

 In this type the mobile phase is gas and stationary phase is liquid.

Principle:-

The mean principle GC is the partition when the sample which after
apply in to the stationary phase it get converted in to the volatile phase
and gaseous phase and this sample component gaseous phase is mixed
with the mobile phase by the help of partition they are separate out.

Instrumentation:-

1. Carrier gas (He, N2, H2, Ar)

2. Sample injection port(micro syringe)
3. Columns
4. Detectors(TCD, FID, ECD,FPD)

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Carrier
gas:-

Carrier gas is an inert gas used to carry samples. Helium (He), nitrogen
(N2), hydrogen (H2), and argon (Ar) are often used.
Helium and nitrogen are most commonly used and the use of helium is
desirable when using a capillary column.

Sample injection:-
Sampling unit or injection port is attached to the column head.

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Since the sample should be in vaporized state the injection port is

provided with an oven that helps to maintain its temperature at about
20-50c above the boiling point of the sample.

Gaseous sample may be introduced by use a gas tight hypodermic

needle of 0.5-10ml capacity.

For liquid samples, micro syringes of 0.1-100microliter capacity.

Columns:-
Columns are of different shapes and sizes that include U tube type or
coiled helix type.

A column is placed in a thermostatic oven which does the separation,

commonly used columns are DB-624, DB-1.

Detector:-
A wide variety of detector is used for compound detection.

E.g. FID, ECD, TCD, NPD.

Working:-
 A carrier gas continuously flows through the column.
 Sample is injected by the injector into the column.
 Carrier gas pushed the sample through the column.
 Compound of sample interact with stationary phase and get
separated.
 Separated components detected by the detector& data are
recorded by the software.

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HPLC
High performance liquid chromatography (HPLC):
Introduction:-
High-performance liquid chromatography (HPLC; formerly referred to
as high-pressure liquid chromatography) is a technique in analytical
chemistry used to separate, identify, and quantify each component in a
mixture. It relies on pumps to pass a pressurized liquid solvent
containing the sample mixture through a column filled with a solid
adsorbent material. Each component in the sample interacts slightly
differently with the adsorbent material, causing different flow rates for
the different components and leading to the separation of the
components as they flow out of the column.

Principle:-
The purification takes place in a separation column between a
stationary and mobile phase. The stationary phase is a granular
material with very small porous particles in a separation column.

The mobile phase on the other hand is a solvent or solvent mixture

which is forced at high pressure through the separation column. Via a
valve with a connected sample loop, i.e. a small tube or a capillary
made of stainless steel, the sample is injected into the mobile phase
flow from the pump to the separation column using a syringe.
Subsequently the individual components of the sample migrate through
the column at different rates because they are retained to a varying
degree by interactions with the stationary phase. After leaving the
column the individual substances are detected by a suitable detector

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and passed on as a signal to the HPLC software on the computer. At the

end of this operation a chromatogram in the HPLC software on the
computer is obtained, which allows the identification and
quantification of the different substances.

INSTRUMENTATION OF HPLC:-
 Pump
 Mixing unit
 Solvent
 Injector
 Column
 detectors

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Pump: - A pump suctions the versatile stage from the dissolvable

reservoir and drives it through the framework's column and detector.
Contingent upon various components including column measurements,
molecule size of the stationary stage, the stream rate and synthesis of
the versatile stage, working weights of up to 42000 kPa (around 6000
psi) can be created.

Mixing unit:-

Mixing unit is used to mix solvents in different proportion and pass

through the column.

Sample Injector: The injector can be a solitary infusion or a mechanized

infusion framework. An injector for a HPLC framework ought to give
infusion of the liquid specimen inside the scope of0.1-100 mL of volume
with high reproducibility and under high weight (up to 4000 psi).

Columns: Columns are generally made of cleaned stainless steel, are in

the vicinity of 50 and 300 mm long and have an inside distance across
of in the vicinity of 2 and 5 mm. They are normally loaded with a
stationary stage with a molecule size of 3-10 um. Columns with interior
distances across of under 2 mm are regularly alluded to as micro bore
HPLC columns. In a perfect world the temperature of the portable stage
and the column ought to be kept steady amid an examination.

Detector: The HPLC indicator, situated toward the finish of the column
distinguishes the analytes as they elute from the chromatographic
column. Regularly utilized finders are UV spectroscopy, fluorescence,
mass-spectrometric and electrochemical indicators.

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XRD INSTUMENT:-
X-ray diffraction (XRD) is a powerful nondestructive technique
for characterizing crystalline materials. It provides information
on structures, phases, preferred crystal orientations (texture), and
other structural parameters, such as average grain size,
crystallinity, strain, and crystal defects.

Principle:-

Based on the constructive interference of monochromatic

x-rays and a crystalline sample in which the crystalline
structure causes a beam of incident x-rays to diffract into
many specific directions.

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NMR (nuclear magnetic resonance):-

It is a spectroscopy technique that is based on the absorption of
electromagnetic radiation in the radiofrequency region 4 to 900
MHz by nuclei of the atoms.

 NMR has become the preeminent technique for determining

the structure of organic compounds.

Principle:

1. The principle behind NMR is that many nuclei have spin and all
nuclei are electrically charged. If an external magnetic field is
applied, an energy transfer is possible between the base energy
to a higher energy level (generally a single energy gap).
2. The energy transfer takes place at a wavelength that
corresponds to radio frequencies and when the spin returns to
its base level, energy is emitted at the same frequency.
3. The signal that matches this transfer is measured in many ways
and processed in order to yield an NMR spectrum for the
nucleus concerned.

Instrumentation of NMR:-

1. Sample holder
2. Permanent magnet
3. Magnetic coils
4. Sweep generator
5. Radio frequency transmitter
6. Radio frequency receiver

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1. sample holder:
Glass tube with 8.5 cm long,0.3 cm in diameter.
2. permanent magnet:
it provides a homogeneous magnetic field at 60-100MHZ.
3. magnetic coils:

These coils induce a magnetic field when current flows through

them.
4. Sweep generator
To produce an equal amount of magnetic field pass through
the sample.
5. Radio frequency transmitter
A radio transmitter coil transmitter that produces a short
powerful pulse of radio waves.
7. Radio frequency receiver
A radio receiver coil that detects radio frequencies emitted as
nuclei relaxes to a lower energy level.

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Working:

 The sample is placed in a magnetic field and the NMR signal

is produced by excitation of the nuclei sample with radio
waves into nuclear magnetic resonance, which is detected
with sensitive radio receivers.
 The intramolecular magnetic field around an atom in a
molecule changes the resonance frequency, thus giving
access to details of the electronic structure of a molecule and
its individual functional groups.
 As the fields are unique or highly characteristic to individual
compounds, NMR spectroscopy is the definitive method to
identify monomolecular organic compounds.
 Besides identification, NMR spectroscopy provides detailed
information about the structure, dynamics, reaction state,
and chemical environment of molecules.
 The most common types of NMR are proton and carbon-13
NMR spectroscopy, but it is applicable to any kind of sample
that contains nuclei possessing spin.

UV visible Spectroscopy:
Used for quantitative analysis of matter/ sample by using UV and
visible light.
 The overall range of wavelength of UV& visible is 200-
800nm.
Principle:
UV visible spectroscopic principle depends upon the adsorption
of light.

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Instrumentation:
 Source of radiation
 Wavelength selector
 Sample cells/cavettes
 Detector
 Recording system

Source of radiation:

The best source light is the one which is more stable, more
intense and which gives the range of spectrum from 200-800.

 Hydrogen discharge lamp

 Deuterium lamp

Wavelength selector:

It consists of monochromater and slits.

 The essential of a monochromator are an entrance slit, a

dispersing element and exist slit.
 The dispersing element may be a prism or generally made of
glass, quartz, or fused silica.

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Slits: entrance slit for entry of light and exit slit passed the single
Radiation of desired wavelength.
 Wavelength selector is the device which gets the light from
source of radiation and passes the light with desired
wavelength which is required for detection to the sample.

Sample cells:

 These are sample containers which hold the liquid samples.

 They are transparent& usually made up with quartz or fused
silica also silicate glass.

Detectors:

 Detectors used in UV- visible spectrophotometer can be called as

photometric detectors.
 These are those devices which converts light source into electrical
signal which finally displayed by recording system.

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