Thesis On Plant Base Oil
Thesis On Plant Base Oil
SKILL DEVELOPMENT
PREPARED BY
ENROLLMENT NO:2025402900118
M.PHARM (PHARMACOLOGY)
ASSISTANT PROFESSOR
SUBMITTED TO
BACHLOR OF PHARMACY
WINTER – 2023
This is to certify that Practice School BP705PP report embodied in this entitled “SKILL
DEVELOPMENT” was carried out by PATIL SAMMED JIVANDHAR (Enrollment
No. 202540290118) studying in 7th semester B.Pharm at Shree Dhanvantary Pharmacy
College, Kim (254) for partial fulfillment of B.Pharm degree to be awarded by Gujarat
Technological University. This practice school (BP705PP) work has been carried out under
my guidance and supervision and it is up to my satisfaction.
DATE:
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ACKNOWLEDGEMENT
This project consumed amount of work, lots of research, dedication, skills and its
implementation which would have not been possible without help, support and guidance of
many individuals and organizations. Therefore, I would like to express my sincere gratitude
to all of them.
I would like to thank and express my gratitude to my project in-charge RUMANA MAM,
assistant professor at SHREE DHANVANTARY PHARMACY COLLEGE, KIM for her
cooperation and guidance throughout my practice school training practical.
I’m cordially grateful to my beloved parents and my dear friends for their moral support,
love and blessing
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INDEX
5 UV Spectroscopy
7 Gas Chromatography
8 Industrial Visit
9 Conclusion
10 Annexure
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GUEST LECTURE-1
Date: 19/08/2023
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features while maintaining the utmost safety and effectiveness of medical
devices.
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GUEST LECTURE-2
Name of Speaker: Mr. Anand Pande, DGM Quality Control, Zydus Life Science
Date: 2/09/2023
Introduction
This report outlines the key aspects of Good Laboratory Practice (GLP) and Schedule L-1,
which are essential for maintaining the quality, integrity, and reliability of laboratory data in
the context of pharmaceutical and chemical industries. These guidelines ensure that
laboratories conduct experiments, studies, and tests in a systematic and controlled manner
to generate accurate and reproducible results.
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Key Principles
1. Quality System Management: Establishing and maintaining a comprehensive
quality system that covers all aspects of laboratory operations.
6. Sample Handling: Proper handling, storage, and disposal of test substances and
samples.
Benefits of GLP
• Ensures the safety and efficacy of pharmaceuticals and chemicals.
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Key Provisions
1. Premises and Equipment: Specifies requirements for the design, construction,
and maintenance of manufacturing and testing facilities. It also outlines guidelines for
equipment validation.
3. Quality Control: Describes the procedures for sampling, testing, and release of
raw materials, intermediates, and finished products.
7. Batch Release: Outlines the responsibilities and requirements for batch release
by the authorized person.
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GUEST LECTURE-3
Date: 16/09/2023
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Description:
1. Research and Development (R&D)
The Research and Development department is the heart of any pharmaceutical company. Its
responsibilities include:
2. Manufacturing
The Manufacturing department ensures the efficient and consistent production of
pharmaceuticals:
• Drug Formulation: Developing the processes to create the final drug product,
including determining the appropriate dosage form (tablets, capsules, injections, etc.).
• Quality Control: Monitoring the quality of raw materials and finished products
through rigorous testing to meet regulatory standards.
3. Regulatory Affairs
Regulatory Affairs plays a crucial role in ensuring that pharmaceutical products meet legal
and regulatory requirements:
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4. Marketing and Sales
The Marketing and Sales department focuses on promoting and distributing pharmaceutical
products:
5. Medical Affairs
Medical Affairs is responsible for providing medical and scientific expertise:
• Compliance: Ensuring that the company follows all relevant regulations and
guidelines.
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8. Finance and Administration
The Finance and Administration department is responsible for the financial health of the
company:
9. IT and Technology
Information Technology and Technology departments play a critical role in data
management, cybersecurity, and digital transformation:
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GUEST LECTURE-4
Date: 22/09/2023
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Introduction:
• Curing Genetic Diseases: Potential to cure genetic disorders like sickle cell
anemia and cystic fibrosis at the genetic level.
3. Synthetic Biology
Synthetic biology is an interdisciplinary field that combines biology, engineering, and
computer science to design and construct new biological parts, devices, and systems. The
futuristic applications are vast:
4. Regenerative Medicine
Regenerative medicine holds the promise of replacing or regenerating damaged tissues and
organs:
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• Stem Cell Therapy: Using stem cells to repair damaged tissues and treat
conditions such as spinal cord injuries and heart disease.
6. Environmental Biotechnology
Biotechnology can contribute significantly to solving environmental challenges:
7. Nanobiotechnology
Nanobiotechnology involves the integration of nanotechnology and biotechnology for
novel applications:
• Drug Delivery: Precise drug delivery systems using nanoparticles to target specific
cells or tissues.
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EQUIPMENTS USED IN QA DEPARTMENT
QA (QUALITY ASSURANCE)
It is the way of preventing mistake and defects in manufactured products and avoiding
problems whe services is delivered to customers.
Now in pharmaceutical industries QMP and cGMP are very important aspects in an
organization.
QA Qulity Assurance
QC Quality Control
In the pharmaceutical industry, qulity assurance (QA) is essential for ensuring that
pharmaceutical product are manufactured to a safe and consistent standard.
QA is area that refers to any aspect that affect a drugs quality during its research, development
and manufscturimg.
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List of Quality Eqipment:
Crock meter
Electric Balance
Iorn
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UV SPECTROPHOTOMETRY
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packets of photons. The relation between the energy of a photon and the frequency
appropriate for the description of its propagation is
E = hv
Where, E = Energyinergs
v = Representsfrequency incyclespersecond
h = Plank's constant (6.6256 x 10-27 erg-sec)
The data obtained from a spectroscopic measurement are in the form of a
plot of radiant absorbed or emitted as a function of position in the
electromagnetic spectrum. This is known as a spectrum and the position of
absorption or emission is measured in units of energy, wavelength or
frequency.
Beer-Lambert’s law:
Colorimetry is the determination of the light absorbing capacity of a system. A
quantitative determination is therefore, carried out by subjecting a colored
solution to those wavelengths of visible energy which are absorbed by that
solution. UV and visible absorption bands are due to electronic transitions in
the region of 200 nm to 780 nm. In case of organic molecules, the electronic
transitions could be ascribed to a s, p or n electron transition from the ground
state to an excited state (s*, p* or n*).There are four types of absorption bands
that occur due to the electronic transition of a molecule. R - Bands: n p*, in
compounds with C=O or NO2 group k - Bands: p p*, in conjugated systems.
b - Bands (Benzenoid bands): Due to aromatic and heteroaromatic systems
E - Bands (ethylenic bands): In aromatic systems.
When light (monochromatic or heterogeneous) falls upon a homogeneous
medium, a portion of the incident light is reflected, a portion is absorbed within
the medium and the remainder is transmitted. If the intensity of the incident
light is expressed by I, that of the absorbed light by Ia, that of the transmitted
light by It, and that of the reflected light by Ir, then:
Credit for investigating the change of absorption of light with the thickness
medium is frequently given to Lambert; Beer later applied similar experiments to
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solutions of different concentrations and published his results. The two separate
laws governing absorption are usually known as Lambert's law and Beer's law. In
the form they are referred to as the Beer-Lambert law. Mathematically, the
radiation-concentration and radiation-path length relation can be expressed by
......................(2)
The more familiar equation used in spectrometry
log (I/I0) = a* c * l ...................(3)
c = concentration
l = thickness of the absorber (in cm) a = molar
absorbtivity for concentration in moles/L
Represents a concentration of 1% w/v and 1 cm cell thickness and is used
primarily in the investigation of those substances of unknown or undetermined
molecular weight.
PRINCIPLE OF QUANTITATIVE SPECTROPHOTOMETRIC ASSAY OF
MEDICINAL SUBSTANCES:
The assay of an absorbing substance may be quickly carried out by preparing a
solution in a transparent solvent and measuring its absorbance at a suitable
wavelength. The concentration of the absorbing substance calculated from the
measured absorbance using one of three principal procedures.
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UV-VISIBLE INSTRUMENTATION COMPONENTS OF UV-VIS
SPECTROPHOTOMETER:
1. SOURCE
2. COLLIMATING SYSTEM
3. MONOCHROMATORS
4. SAMPLE HOLDER
5. DETECTORS
6. READ OUT DEVICES
1.
2.
3.
4.
1.Lenses
2.Mirrors
3.Slits
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Monochromators
1.Fiters
2.Prisms
3.Gratings
Detectors
1.Barrier Layer Cell/Photovoltaic cell
2.Phototubes/Photo emissive tube
3.Photomultiplier tube
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Calibration SOP of UV
5.2.1 Reagents:
Sulphuric acid (AR Grade),
Purified water,
Potassium dichromate (AR Grade).
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5.2.2 Preparation of 0.005M Sulphuric acid solution:
Pipette 5.4 mL of Sulphuric acid in 100 mL volumetric flask and add 30 mL
water, mix well and make up volume with water. Pipette 10.0 mL of above
solution in 2000 mL volumetric flask, make up volume with water.
5.2.3 Preparation of Potassium dichromate solution: Use potassium
dichromate after reading instructions from the supplier COA, if not specified
in the supplier's COA then proceed as per the reagent preparation provided in
pharmacopoeia. Weigh accurately about 60 mg (57.0 mg to 63.0 mg)
Potassium dichromate into a 100 mL volumetric flask. Add 30 mL 0.005M
Sulphuric acid, dissolve and make up the volume with 0.005M Sulphuric acid.
(Use this solution for 430 nm)
Pipette 10 ml of above solution in 100 ml volumetric flask and dilute to
volume with 0.005M Sulphuric acid solution. (Use this solution for 235nm,
257 nm, 313nm, 350nm).
5.2.4 Check the absorbance of Potassium dichromate solution, using 0.005M
Sulphuric acid as a blank at the following wavelengths: 235, 257, 313 and 350
nm. Calculate the value of Specific absorbance "A (1%, 1-cm)" as per the
following formula:
A (1%,1 cm) = Absorbance x 10 x 1000
Weight of K,Cr,O, in mg
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---------------------------
Weight of K,Cr₂O, in mg
The expression A (1%, 1cm) representing the Specific absorbance of dissolved.
5.3
5.3.3 Scan the solution between 190 nm to 220 nm, use water as a blank.
using 1 cm cuvette
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5.3.4. Acceptance criteria:
The absorbance of the above solution at 198 nm should not be less than 25.4
Resolution:
5.4.1 Reagent:
Toluene (AR Grade), Hexane (AR Grade).
5.4.2. Preparation of 0.02% v/v solution of toluene in hexane: Pipette 1.0 mL of
Toluene into 50 mL volumetric flask and add 30 mL hexane, shake for few minutes
and make up volume with hexane.
Pipette 5.0 mL of above solution into 50 mL volumetric flask and make up the volume
with hexane.
Further pipette 5.0 mL of above solution into 50 mL volumetric flask and make up the
volume with hexane.
5.4.3 Scan the sample between 260 nm to 275 nm. Use hexane as a blank. using 1 cm
cuvette
5.4.4 Check the absorbance maximum at 269 nm and minimum at 266 nm. Take the
ratio of absorbance of 269 nm and 266 nm and fill the data as per Annexure-II.
5.4.5 Acceptance Criteria:
Ratio of absorbance about 269 nm and 266 nm is not less than 1.5.
5.5 Resolution Power (Secondary Derivative):
5.5.1 Reagent:
Toluene (AR Grade), Methanol (HPLC Grade).
5.5.2 Preparation of 0.02% v/v solution of toluene in methanol: Pipette 2.0 ml. of
Toluene into 200 mL volumetric flask and add 50 ml. methanol, shake for few minutes
and make up volume with methanol. Pipette 2.0 mL of above solution into 100 ml.
volumetric flask and make up the volume with methanol.
5.5.3 Instrument Method Parameter
Measuring Mode: Spectrum Slit With: 1.0 nm
Wavelength: 255 nm to 285 nm
Sampling Interval: 0.05
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Scaling Mode: Slow
5.5.4 Perform the baseline correction in the range 255 to 285 nm for spectrum. Use
methanol as blank, using 1 cm cuvette
5.5.5 Scan the sample between 255 nm to 285 nm and save the spectra.
5.5.6 Click the 'Manipulate' option; screen will appear with 'Type, Dataset, Operation,
Constant and Calculate'
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5.5.7 Set the above-mentioned parameters as below, 5.5.12
5.6 Make entry of calibration in the equipment logbook as per SOP QC-088.
5.9
5.10
5.10.1
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FTIR (Fourier Transform Infrared Spectroscopy)
A method of obtaining an Infrared spectrum by measuring the interferogram
energy of the vibration and the energy of mid-infrared light are equivalent, the
bond can absorb that energy. Different bonds in a molecule vibrate at different
molecule.
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Reactions optimize reaction yield and minimize by-product impurities. In
chemical and pharmaceutical production, FTIR spectroscopy functions as a
process analytical technology (PAT), ensuring that processes are stable and in
control and achieve final product specifications.
Work:
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The ATR method is an ideal complement to FTIR instrumentation for analysis
and monitoring of chemical reactions. The restricted depth of penetration of
the infrared energy into the sample permits high-quality FTIR spectra of
optically dense reaction mixtures. The neat solution phase of a chemical
reaction is measured and bubbles, particles, catalysts, biological solids, water,
etc., do not interfere with the measurement.
Suitable ATR sensors for analyzing chemical reactions must have the requisite index
of refraction to enable internal reflection and must also perform in harsh chemical
environments without degrading. Both diamond and silicon are excellent sensor
materials for FTIR-ATR, and the choice of which to use is dependent on the type of
chemistry and the infrared peak positions that need to be tracked.
CALIBRATION OF FTIR:
Ensure that, the instrument is ready for calibration and the start-up procedure
is followed.
Ensure that the Instrument is ready for the calibration and start-up the
procedure is followed.
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After selecting “EP 5.0 validation”.
Click on “Measurement”.
After background validation completion,“ Set polystyrene film into the sample
chamber” is displayed in the screen.
Set the polystyrene film accordingly and click on “OK”, scanning will start.
After completion of the validation the report will be generated and printed
automatically.
Compare the results for its compliance against limits given in validation
format and put remark regarding validation status.
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HPLC AND GC DEMONSTRATRION
High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) are two
common techniques used for chemical analysis and separation of compounds. Here's a brief
overview of how to use each of these techniques:
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HPLC (High-Performance Liquid Chromatography):
1. Sample Preparation:
- Prepare your sample by dissolving or suspending it in a suitable solvent. Ensure the sample
is filtered to remove particulate matter if necessary.
2. Instrument Setup:
- Set the flow rate, temperature, and detector settings according to your method.
3. Mobile Phase:
- Prepare the mobile phase, which is a solvent or solvent mixture. It should be filtered and
degassed to remove air bubbles.
- Ensure that the mobile phase is compatible with your sample and column.
4. Sample Injection:
- Inject your prepared sample into the HPLC instrument. This can be done manually or using
an autosampler.
5. Separation:
- Start the HPLC run, and the sample will pass through the column.
- The components in your sample will interact with the stationary phase, causing separation
based on their chemical properties (e.g., size, polarity).
6. Detection:
- The separated components will pass through a detector (e.g., UV, fluorescence, or mass
spectrometry) that quantifies their presence.
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7. Data Analysis:
- Analyze the chromatogram to determine the retention times, peak shapes, and areas for each
component.
- Compare your results with standards or known compounds for identification and
quantification.
8. Maintenance:
- After your analysis, flush the column with a suitable solvent to clean it.
- Properly shut down the HPLC instrument, ensuring it is ready for the next use.
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GC (Gas Chromatography):
1. Sample Preparation:
2. Instrument Setup:
- Install the appropriate column for your analysis (e.g., capillary column).
3. Carrier Gas:
- Select a carrier gas (e.g., helium, nitrogen) and set the flow rate.
4. Sample Injection:
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- Inject your sample into the GC instrument, either manually or using an autosampler.
5. Separation:
- Start the GC run, and the sample will be vaporized and pass through the column.
- Separation occurs based on the interaction of the sample with the stationary phase within
the column.
6. Detection:
- As the separated components exit the column, they pass through a detector (e.g., FID, TCD,
ECD) that measures their concentration.
7. Data Analysis:
- Identify and quantify compounds by comparing retention times with standards or known
compounds.
INDUSTRIAL VISITS
Skill Development Program
Industrial Visit
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Name of Company: Ribosome research Centre
Address: Sr No.261/1, Block No. 271, near Shri Dhanvantary Pharmacy College,
Kim, Gujarat 394110
Date: 26/08/2023
Introduction:
The industrial visit to the Ribosome Research Centre offered a distinctive opportunity
for participants to gain profound insights into the cutting-edge advancements within the
realm of molecular biology and biotechnology. Renowned for its pioneering research in
ribosome structure, function, and its roles in diverse cellular processes, the Ribosome
Research Centre was the focal point of this enlightening experience. During the visit,
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attendees had the privilege of touring the laboratory facilities, engaging with
researchers, and directly witnessing ongoing research endeavors.
Objectives:
1. To grasp the significance of ribosome research in the domains of molecular biology
and cellular processes.
2. To acquire knowledge about the state-of-the-art laboratory techniques and equipment
employed in ribosome research.
3. To observe practical applications of ribosome research in the realms of biotechnology
and medicine.
4. Interaction with Researchers: A highlight of the visit was the direct interaction with
researchers and scientists at the centre. Participants engaged in in-depth discussions
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regarding ongoing projects, research challenges, and the potential applications of
ribosome research in various domains, such as drug discovery and genetic engineering.
6. Q&A Session: The visit concluded with a question and answer session, affording
participants the opportunity to seek clarification on various aspects of ribosome
research and delve deeper into specific areas of interest.
Key Takeaways:
1. Ribosome research is a multidisciplinary field of paramount importance in
comprehending cellular processes and molecular biology.
2. Advanced techniques, such as cryo-electron microscopy, have revolutionized our
capacity to study ribosome structures at exceptionally high resolutions.
3. Ribosome research extends its influence into diverse domains, including medicine,
genetic engineering, and biotechnology.
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ALPHARD PHARMA: -
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QUALITY MANAGEMENT SYSTEM: -
Short description of the Quality Management System of the firm
responsible for Manufacturing Quality division of Alphard Pharma is a
distinct organization body that functions and reports to authorized
partners and is independent of all other plant functions. Head of Quality
division is technically qualified with remarkable experience in the
responsible area. Site In charge – Quality Assurance reports to
Managing Director.
Alphard has adopted a policy of operating the pharmaceutical
manufacturing under control of Quality Management System, installed
and operating as stated under the Quality Manual. It is also our policy
to update the standards as per WHO, cGMP and customer requirements
with mutual dialogue. The quality control department is fully
authorized to take appropriate decision on quality matters.
Departments of ALPHARD
1.Qurantine Room
7. Instrument Room
8. Physico-chemical Lab
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ZYDUS LIFESCIENCES
LIMITED
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Purpose: Empower people with the freedom to live healthier and more fulfilled
lives.
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• Nutralite. Healthier & Delicious.
• Sugar Free Product:
From twenty-five pharmaceutical production operations in India and
Zydus Cadila develops and manufactures an extensive range of
pharmaceuticals as
well as diagnostics, herbal products, skincare products and other OTC
products. Starting from late 2015, having concluded a voluntary license
agreement with Gilead, the company also produces the generics for
hepatitis C treatment
(i.e. sofosbuvir, distributed under the brand name SoviHep).
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Ranitidine (Zydus) 300 mg tablet:
• USES:
• Gastric and duodenal ulcers
• Gastroesophagal Reflux Disease
• Erosive Esophagitis
• Zollinger-Ellison Syndrome
• Hypersecretory Condition
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Antiseptic:
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Conclusion
Hands on training of different equipments like FTIR, UV spectroscopy, HPLC, GC, flame
photometry of QA department use to check the quality of different dosage forms helps us for
better and detailed operative or practical knowledge and to develop our skills in these
instruments so that in future we would have better practical knowledge in operating these
instruments and will be easily eligible for job in FDCA related and QA related jobs in
industries.
Seminar sessions in this program teaches about theoretical and informative knowledge of
about different schedules, HPLC, Quality and safety guidelines organized by different
professors ,FDCA commissioner, Drug inspector ret. assistant professor which helps in
One of the major part in skill development was industrial visit organized by our college at
Alphard pharma which is a small scale industry and other visit was in Zydus life sciences
which is an API unit in Ankleshwar. This visit gives us a thoroughly practical knowledge
about how a drug is made starting from getting raw material to the packaging and how the
API plant operates and safety guidelines to keep during working in industry.
I learned a lot of things in this program and feeling grateful to be a part of this program and
learned a lot of new things which will be never taught in any colleges or universities.
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ANNEXURE
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