Industrial training

FDC India LTD.

(A part of skill development cell)

Submitted by:

Name: Vivek Ramnarayan Kushwaha.

Final year B-Pharm student at H.K. College
of pharmacy.
Relief road, Pratiksha Nagar,
Oshiwara, Jogeshwari West
Mumbai- 400102.
Maharashtra

Date: 13th July 2021.

 TABLE OF CONTENTS

Content Page
no.
Acknowledgment 1
Internship certificate 2
Information about the industry 3
Knowledge acquired 6
Description of internship experience 22
Conclusion 23
 ACKNOWLEDGMENT

Knowledge has no boundaries and there is no end to it. It has been good
experience training with FDC India LTD. The entire staff of the
organization was very cooperative and helpful. The training opportunity
with FDC India LTD. was a great chance for learning and develop
professionally.
I express sincere gratitude and thanks to the respected head of the
research and development department Mr. Zafrullah Khan Sir who
provided me with immense guidance and support during my internship.
Iam also thankful to Dr. M.N Saraf Sir, our principal, and Dr. Jaya
Agnihotri Madam who gave us the opportunity so we can gain experience
and acquire knowledge.
IINTERNSHIP CERTIFICATE
 INFORMATION ABOUT INDUSTRY

"A journey of a million miles begins with a small step." A young

visionary, Anand Chandavarkar, in the backdrop of India's
independence struggle, dreamed of building a world class company.
His vision of freedom was to create, to build, and to industrialize, to
make the nation self-reliant in healthcare. With this aim in mind a
partnership firm was incorporated in 1936, In 1940, this partnership
firm was incorporated as a private limited company - Fair deal
Corporation (Private) Limited and in 1986 its name was changed to
FDC Private Limited. Thereafter, FDC became a public limited
company, and was listed on the Bombay and National Stock Exchanges
of India in 1996.

Today, FDC carries forward the flaming spirit of its first dream,
achieving accreditations from the US-FDA, UK-MHRA, MCC-RSA, and
the UAE, to cite a few. FDC is a forerunner in manufacturing and
marketing of Oral Rehydration Salts (ORS) and Ophthalmic. FDC has
also set-up globally approved, multi-location manufacturing facilities
for Active Pharmaceuticals Ingredients (APIs) as well as Finished
Dosage Forms. These facilities are located at Roha, Waluj and Sinnar
in Maharashtra, Verna in Goa, and Baddi in Himachal Pradesh. FDC
markets more than 300 products in India and exports many of these
to over 50 countries.

FDC strives to explore, innovate, and integrate solutions with modern

technology, empowering talent and expanding healthcare
horizons for a better quality of life to millions globally.

3|Page
FORMULATION DEVELOPMENT
FDC is a research-oriented organization. The R & D Formulation team
is continuously working on various novel compounds and
technologies. Formulation research forms the most significant pillar of
FDC’s growth strategy. The R & D Formulation team designs and
develops simple and complex dosage forms, for the domestic and
global market. The major focus is on creating niche products, using
highly specialized technology.

The R & D team works on continuous up-gradation of process and

technology, so that the product range meets the international
standards. The extensive research work has led to breakthrough
inventions, which have been protected under patent applications.

The analytical laboratories are well equipped with sophisticated

instrumentation. Analytical Method Development adopts Quality by
Design approach. The analytical team fulfils national, as well as
international requirements.

The regulatory team is actively involved in submission of dossiers in

regulated markets, as well as rest of the world.

ANDAs Filed / Approved: Timolol Maleate ED, Ciprofloxacin ED,

Ofloxacin ED, Dorzolamide ED, Dorzolamide and Timolol ED,
Latanoprost ED and Cefixime Tablets.

EU Approvals: Timolol Maleate ED, Sodium Chromoglycate ED,

Betaxolol ED, Hypromellose ED, Chloramphenicol ED, Latanoprost ED,
Fluconazole Capsules and Amlodipine Tablets.

4|Page
ORGANIC SYNTHESIS
R & D has a State-of-the Art facility, with capability of performing
cryogenic and hydrogenation reactions. The R&D team consists of
highly qualified Scientists, supported by QC & RA team for Regulatory
filings, with the respective authorities.

The department has expertise in carrying out asymmetric synthesis,

catalytic hydrogenations, cryogenic reactions, handling of pyrophoric
and moisture sensitive reagents. It also has a wealth of experience in
developing novel polymorphs and dynamic resolutions of racemic
mixtures, into pure enantiomeric form. The laboratories are well
equipped with LC-MS, HPLCs, UPLC, GCs, IR, Polarimeter, Stability
Chamber, Vacuum Drier, Lyophilize and Chiral Preparatory HPLC.

The department actively collaborates with other premier institutions

for the development of New Chemical Entities.

All APIs, produced by FDC, meet ICH standards, and are

commercialized. FDC has a strong presence in the export market.

5|Page
 KNOWLEDGE ACQUIRED

HPLC (HIGH PERFORMANCE LIQUID

CHROMATOGRAPHY)
High-performance liquid chromatography (HPLC) involves the
injection of a small volume of liquid sample into a tube packed with
tiny particles (3 to 5 microns (µm) in diameter called the stationary
phase) where individual components of the sample are moved down
the packed tube with a liquid (mobile phase) forced through the
column by high pressure delivered through a pump.

The column packing is used to separate the components from one

another. It involves various chemical and/or physical interactions
between their molecules and the packing particles.

The separated components are then detected at the exit of the

column by a detector that measures their amount. Output from this
detector is called a “liquid chromatogram.”

6|Page
The following variants of HPLC depend upon the phase system
(stationary) in the process.

1. Normal Phase HPLC

• They are also known as normal-phase or absorption

chromatography. This method separates analytes based on
polarity.
• It has a polar stationary phase and a non-polar mobile phase.
• Therefore, the stationary phase is usually silica, and typical
mobile phases are hexane, methylene chloride, chloroform,
diethyl ether, and mixtures.
• The technique is used for water-sensitive compounds,
geometric isomers, cis-trans isomers, class separations, and
chiral compounds.

2. Reverse Phase HPLC

• The stationary phase is nonpolar (hydrophobic), while the

mobile phase is an aqueous, moderate polar.
• It works on the principle of hydrophobic interactions; hence the
more nonpolar the material is, the longer it will be retained.
• This technique is used for non-polar, polar, ionizable, and ionic
molecules.

3. Size-exclusion HPLC

• It is also known as gel permeation chromatography or gel

filtration chromatography.
• The column is filled with a material having precisely controlled
pore sizes, and the particles are separated according to their
molecular size.
• Larger molecules are rapidly washed through the column;
smaller molecules penetrate the porous packing particles and
elute later.

7|Page
 • Size-exclusion chromatography is also helpful in determining
the tertiary and quaternary structure of proteins and amino
acids.
• It is also used for the determination of the molecular weight of
polysaccharides.

4. Ion-Exchange HPLC

• In this type of chromatography, retention is based on the

attraction between solute ions and charged sites bound to the
stationary phase.
• Same charged ions are excluded.
• This technique is used in purifying water, Ligand and Ion-
exchange chromatography of proteins, high-pH anion-exchange
chromatography of carbohydrates and oligosaccharides, etc.

5. Bio-affinity HPLC

• In this type of chromatography, separation is based on the

reversible interaction of protein

8|Page
UPLC (ULTRA PERFORMANCE LIQUID
CHROMATOGRAPHY)
It is a combination of a 1.7 μm reverse-phase packing material and a
chromatographic system that can operate at pressures in the 6000–
15 000 psi range (conventional HPLC uses 3–5 μm packing material
and operates between 2000 and 4000 psi). There is a greater (S/N)
due to the reduction in band broadening, and thus an increase in
sensitivity. This has enabled better chromatographic peak resolution
and increased speed and sensitivity to be obtained for complex
mixture separation. The typical peak widths generated by UPLC are
in the order of 1–2 s for a 10 min separation. Because of the much-
improved chromatographic resolution of UPLC, the problem of ion
suppression from coeluting peaks is greatly reduced. UPLC coupled
to a Q-TOF mass spectrometer is a powerful tool for analysing
complex mixtures.

9|Page
GAS CHROMATOGRAPHY
The sample solution is placed into the gas chromatograph and enters
the gas stream which transports the sample into the column
(separation tube). A carrier gas is used in the form of helium or
nitrogen. The components of the sample are separated inside the
column.

The number of components that exit the column is measured by the

detector. If a sample with an unknown concentration is measured, a
standard sample with known concentration is being injected into the
gas chromatograph.

Detectors are used in a gas chromatograph:

• Mass spectrometer – The majority of gas chromatography

instruments have a mass spectrometer. The gas chromatograph
separates the compounds, and the mass spectrometer
identifies the compound according to fragmentation pattern.
• Flame Ionization Detector – It is highly sensitive to organic
molecules but insensitive to small molecules.
• Thermal conductivity detector – It is less sensitive than a flame
ionization detector but is perfect for preparative applications

10 | P a g e
 because it keeps the sample intact. It detects the molecules of
the sample based on two gas streams comparison. One has the
carrier gas while the other has the carrier gas and the
compound.
• Electron capture detector – It has a cavity that has two
electrodes and a radiation source that emits radiation. The
collision of electrons and carrier gas creates a plasma-
containing electron and a positive ion.

UV SPECTROSCOPY
Spectroscopy is the measurement and interpretation of
electromagnetic radiation absorbed or emitted when the molecules
or atoms or ions of a sample move from one energy state to another
energy state. UV spectroscopy is a type of absorption spectroscopy in
which light of the ultra-violet region (200-400 nm) is absorbed by the
molecule which results in the excitation of the electrons from the
ground state to a higher energy state.

11 | P a g e
PRINCIPLE:

1. Basically, spectroscopy is related to the interaction of light

with matter.
2. As light is absorbed by matter, the result is an increase in the
energy content of the atoms or molecules.
3. When ultraviolet radiations are absorbed, this results in the
excitation of the electrons from the ground state towards a
higher energy state.
4. Molecules containing π-electrons or nonbonding electrons (n-
electrons) can absorb energy in the form of ultraviolet light to
excite these electrons to higher anti-bonding molecular
orbitals.
5. The more easily excited the electrons, the longer the
wavelength of light they can absorb. There are four possible
types of transitions (π–π*, n–π*, σ–σ*, and n–σ*), and they
can be ordered as follows: σ–σ* > n–σ* > π–π* > n–π*
6. The absorption of ultraviolet light by a chemical compound
will produce a distinct spectrum that aids in the identification
of the compound.

12 | P a g e
IR SPECTROSCOPY
Infrared (IR) spectroscopy or vibrational spectroscopy is an analytical
technique that takes advantage of the vibrational transitions of a
molecule. It is one of the most common and widely used
spectroscopic techniques employed mainly by inorganic and organic
chemists due to its usefulness in determining the structures of
compounds and identifying them. The method or technique of
infrared spectroscopy is conducted with an instrument called
an infrared spectrometer (or spectrophotometer) to produce
an infrared spectrum.

PRINCIPLE:

1. Infrared Spectroscopy is the analysis of infrared light

interacting with a molecule.
2. The portion of the infrared region most useful for analysis of
organic compounds have a wavelength range from 2,500 to
16,000 nm, with a corresponding frequency range from
1.9*1013 to 1.2*1014 Hz.
3. Photon energies associated with this part of the infrared
(from 1 to 15 kcal/mole) are not large enough to excite
electrons but may induce vibrational excitation of covalently
bonded atoms and groups.
4. It is known that in addition to the facile rotation of groups
about single bonds, molecules experience a wide variety of
vibrational motions, characteristic of their component atoms.
5. Consequently, virtually all organic compounds will absorb
infrared radiation that corresponds in energy to these
vibrations.
6. Infrared spectrometers, similar in principle to other
spectrometer, permit chemists to obtain absorption spectra
of compounds that are a unique reflection of their molecular
structure.
7. The fundamental measurement obtained in infrared
spectroscopy is an infrared spectrum, which is a plot of
13 | P a g e
 measured infrared intensity versus wavelength (or frequency)
of light.

KARL FISHER TITRATION

Karl Fischer titration is defined as a titration method that uses either

volumetric or coulometric titration to determine the water quantity
present in each analyte.

The principle of Karl Fischer’s titration is completely based on the

oxidation reaction between sulphur dioxide and iodine. Water reacts
with sulphur dioxide and iodine to form hydrogen iodide and sulphur
trioxide. When all the water is consumed, it reaches an endpoint. The
chemical equation that takes place for the reaction between sulphur
dioxide, iodine, and water (which is employed during the Karl Fischer
titration) is given below.

I₂ + SO₂ + H₂O → 2HI + SO₃

14 | P a g e
Karl Fischer Titration Procedure:
1. Volumetric Determination
This technique is suitable in determining water content down to
1 percent of water. The respective sample is dissolved in KF
methanol, and then iodine is added to KF Reagent. Here, the
endpoint is detected potentiometrically.

2. Coulometric Determination
Here, the endpoint is electrochemically detected in this
experiment. Iodine needed for the KF reaction is obtained by
anodic oxidation of iodide from the solution.

DISSOLUTION TESTING
Dissolution testing is an essential analytical procedure that’s
required as part of the final release investigation for solid oral
dosage forms to control product quality, stability, and batch-to-batch
consistency. The primary functions of a dissolution test during early
stages of development are to characterize therapeutic efficacy,
bioequivalence, and bioavailability of API. During later stages of the
15 | P a g e
development process, dissolution testing is also used for quality
control (QC) purposes. The type of dissolution testing performed
along with the information required from the testing will change as
the molecule progresses from the early stages of development to
later in clinical development and towards product registration.

HOT AIR OVEN

Electrical devices work on the principle of dry and hot air convection
(that is circulation of heated air), conduction, and radiation. The hot
air convection process is of two types. a. Gravity convection process:
Heated air expands and possesses less density than cooled air which
rises and displaces the cooler air (the cooler air descends). It
produces inconsistent temperature within the chamber thus has a
slow turnover. b. Mechanical convection: Use of fitted blower or fan
that actively forces heated air throughout all areas of the chamber.

16 | P a g e
This dry heat destroys bacterial endotoxins (or pyrogens) which are
difficult to eliminate by other means. This property makes it
applicable for sterilizing glass bottles that are to be filled aseptically.
Dry heat kills by oxidation, protein denaturation, and toxic effects of
elevated levels of electrolytes and it is more efficient.

VACCUM OVEN
The working principle behind the operation of a vacuum drying oven
involves substantially lowering the ambient pressure to decrease the
boiling point of the liquid in the substance via the use of a vacuum
pump. A considerable reduction in boiling point increases the rate of
evaporation of the liquid and hence fastens the drying rate of the
substance. Moreover, lowering the boiling point indicates that
operating temperatures could be much lower as compared to regular
air oven. Hence, heat sensitive substances could be dried with
minimal effect to their physical or chemical properties. Additionally,
lack of air (or oxygen) during the drying process significantly reduces
the chances of substance oxidation.

17 | P a g e
ANALYTICAL WEIGHING BALANCE
They are highly sensitive lab instruments designed to accurately
measure mass. Their readability has a range between 0.1mg -
0.01mg. Analytical balances have a draft shield or weighing chamber
to prevent the very small samples from being affected by air
currents. They're meant to detect very fine increments, so the
slightest vibrations or breeze can impact the results. As such,
analytical balances should be used in a dedicated room with as few
disturbances as possible. Analytical balances need to be monitored
carefully and calibrated frequently. Most analytical balances have
both automatic internal motorized calibration and calibration with
external weights. Precision balances usually have a higher capacity
than analytical balances do and typically deliver results of 0.1g, 0.01g
or 1mg. Analytical balances have finer readability, are much more
sensitive to changes, and can detect smaller variations in mass.
Precision balances have more variety in body style and options, but
they do not offer readabilities greater than three decimal places. For
acute measurements in labs, analytical balances are the right choice.

18 | P a g e
pH METER

It measures the voltage between the two electrodes. One is a glass

electrode, and the other is a reference electrode. It displays the
result of that voltage that is related to the corresponding pH value.
Sometimes, if both electrons are present, it is called the combination
electrode, and they are inserted into the solution in which pH is to be
tested. These two electrodes are immersed and, after immersing
these electrodes in a solution. That H+ ion in the test solution
exchange for other positively charged ions presents on the glass ball.
So, there is an action between these plus ions of the solution and H+
ions or positively charged ions present on the glass bulb. The
amplifier detects the difference in electric potential between the two
electrodes. The contrast of these potentials is called the pH unit.

It consists of a probe, typically a three-in-one combination. The

electrode has a hydrogen ion-sensitive glass electrode, a reference
electrode, and a temperature probe. The temperature probe is used
to ensure any temperature variation is corrected automatically. At
the tip of the probe is a sensitive glass bulb that detects the acidity

19 | P a g e
or basicity of the solution and at the other end of the probe is a high
input electronic meter that measures and displays the pH.

It has a voltmeter attached to a pH electrode because whatever

those electrodes do respond as per pH, so that’s why these are called
pH-responsive electrodes. Electrode one is here that is the
measuring electrode, and it is a tube made of glass. It consists of thin
glass with a glass bulb. It consists of a narrow tube or glass with a
glass bulb filled with a potassium chloride chemical with a pH of 7.

It also consists of a silver block of silver chloride attached to a silver

element and generates the voltage. It is used to measure the pH of
the unknown solution. Then the second electrode of the pH meter is
the reference electrode. The references electrode is also a glass tube
that consists of a potassium chloride solution. The reference
electrode consists of potassium chloride solution, and it is in contact
with the mercury chloride block, which is present at the end of
potassium chloride. And this reference electrode is used to provide a
stable zero-voltage connection and to complete the circuit.

The pH meter has a flexible arm for easy motion of the electrodes in
and out of the solutions. When the pH meter is not in use, the
electrode is submerged into three molar KCl solutions to prevent it
from drying or direct contact with the environment for a long time.
Drying of the glass membrane may permanently damage the
electrode.

20 | P a g e
21 | P a g e
 DESCRIPTION OF INTERNSHIP
EXPERIENCE

An internship report may be a requirement for one

to completethe internship, but it is also a chance to
share our experiences.
During 4 weeks of internship, I accumulated various and wider
new knowledge through activities and tasks had been assigned
to me. It was immensely eye-opening in terms of exposure to a
corporate company. Observed, analyzed, and then finally step
by step made an understandingand approach to the task. It was
an alluring experience with FDC in R&D Department. Observed
how precision, accuracy,discipline, responsibility, and
confidence are important for the R&D department.
Apart from R&D I also had exposure to the formulation
departmentAnalytical Development Department and CQA
Department.

22 | P a g e
 CONCLUSION
The overall internship was great it helped to enhance my skill,
ability, andknowledge through this industrial training I gained
a lot of knowledge regarding the pharmaceutical industry and
its imminent role in society.
This one-month experience helped me to understand every
basic small step involved in the manufacturing process from
weighting to the disposaland all the GMP requirements that
should comply by the pharmaceutical industry and their
significance for the maintenance of the quality of the
formulation.
In the research and development department, I came to
know about the effort that the company devotes to the
innovation and improvement of itsproducts and process.
Through articles, it helped me to know about crude drugs and
their various type of formulations made with their application.
The treatment by the company was professional and I have
learned aboutthe different units.
I heartily thank all at Umang who guided us during our training
period thetraining will guide us throughout our career and
future life.

23 | P a g e