Professional Documents
Culture Documents
Jumana & Lubnaمشروع التخرج جاهز
Jumana & Lubnaمشروع التخرج جاهز
2021-2022
Summer Semester
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No. Title Page
No.
2
List of Figures 4
1. Introduction 6
2. Drugs Laboratory 7
4. Devices Used 9
4.1 Balance 9
4.2 PH Meter 11
4.2.1 Device Design 12
4.3 Hettich Benchtop Centrifuge ROTOFIX 32 A 12
4.3.1 How to Use ROTOFIX 32 A 13
List of Figure:
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Figure Title Page
No. No.
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1 Logo of Dar Al Dawa Development & Investment Co 6
2 Explanation of The Drug's Label 8
3 Quality control laboratory 9
3 Balance Device 10
4 PH Meter 11
9 Ultrasonic Bath 17
10 High Performance Liquid 18
11 The Part of HPLC 19
12 UV -Visible 21
13 Regions of Electromagnetic 22
14 The Part of UV-Visible Spectrophotometer Device 22
1. Introduction
Dar Al Dawa is a MENA-wide leader in Pharmaceutical and consumer health products. With a
history of more than 40 years. As a fully integrated Pharmaceutical company, we have a long
markets, with more than 900 people serving patients in more than 40 countries throughout
Middle East, North Africa and Europe. Dar Al Dawa possesses a high-performance business
development, production, technology, marketing and commercial teams and business functions.
According to Jordan’s Drug owners association, Dar Al Dawa is ranked first in 2013 considering
the number of new drug registration submissions. The company generated gross revenues of
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US$60 million for the fiscal year ended Dec 31, 2012, an increase of 5.6% versus 2011 results.
We are focused on four core therapy areas – anti-infectives, respiratory, musculoskeletal and
increasingly on CNS and CVS– where we can apply our expertise and resources more effectively
by taking advantage of the knowledge of our integrated teams. Our goal is to develop and
commercialize our compounds and those of our collaboration partners in selected markets where
a company of our size can compete successfully for targeted disease states.(1)
2. Drugs Laboratory
A Drug is defined by us law as any substance (other than food or equipment) intended for
intended to affect the structure or function of the Body. In Body function, not Disease).
This comprehensive definition of a Drug, while important for legal purposes, is complex
and not for everyday use. Therefore, there is a simpler - but practical - definition of a
Drug, which is any Chemical or Biological substance that affects the body and its
processes.
The Generic Name: is the Active Substance in the drug, and it is the substance with which
the drug is registered and approved by international organizations such as the US Food and
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Drug Administration, the European Medicines agency, and others. Pharmaceutical
Trade Name: It is the name given by a company that manufactured the Drug, and it is
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4. Devices Used
4.1 Balance
A Laboratory Balance is a sensitive instrument used to measure the Mass of small quantities of
materials with high accuracy up to the fourth decimal place. Laboratory scales are necessary in the
Volumetric analysis process and are used to measure the Mass of the Drug Tablet, where a certain
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number of pills of the same type are crushed and a specific and accurate weight is taken to
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4.2 PH Meter
A simple and Speedy device to measure the Acidity and Alkalinity of a fluid. A PH meter acts as a
Voltmeter that measures the Electrical Potential difference between a PH Electrode and a reference
Electrode and displays the result in terms of the PH value of the solution in which they are
immersed.
The pH meter was invented in 1934 by the American chemist Arnold O. Beckman (1900-2004) to
measure the sourness of lemons. Beckman's Original device was housed in a walnut box 12 inches
wide, 8 inches deep and 9 inches high. It measured Electrical current flowing into a Glass
Electrode immersed in a solution. The amount of current indicated the solution's acidity.
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They comprise a simple electronic amplifier and a pair of Electrodes, or Alternatively a
combination Electrode, and some form of display calibrated in PH units. It usually has a Glass
Electrode and a reference Electrode, or a combination Electrode. The Electrodes, or Probes, are
The design of the electrodes is the key part: These are Rod-Like structures usually made of glass,
with a bulb containing the sensor at the bottom. The Glass Electrode for measuring the pH has a
the solution to be tested, Hydrogen ions in the test solution exchange for other Positively charged
ions on the Glass bulb, creating an Electrochemical potential across the bulb. The electronic
amplifier detects the difference in electrical potential between the two electrodes generated in the
measurement and converts the potential difference to PH units. The Magnitude of the
electrochemical potential across the glass bulb is linearly related to the pH according to the Nernst
equation.
Value. The Multi-functional and User-friendly centrifuge over-performs on everyday tasks and
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delivers consistent results. Ideal for all standard tubes up to 100 ml and specialty Tubes such as
ROTOFIX 32 A
performance and the comprehensive range of accessories with various swing-out and angle rotors
have helped to make this robust and durable benchtop centrifuge an indispensable tool in the Lab,
with an excellent performance-to-price Ratio. The high-quality design and construction of the
centrifuge helps to make Lab procedures safer and less demanding; it contains Centrifugation
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4.3.1 How to Use ROTOFIX 32 A
1. The practical film keyboard enables parameters to be entered precisely, quickly, and simply
3. The speed is entered in increments of 100 and the centrifugation time is selected in minutes
5. The RCF is displayed for as long as the RCF button is pressed. The rotor radius must be
6. The lid of the centrifuge can be comfortably and reliably closed using the ergonomic
closure(2)
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PTWS 1420 Dissolution Tester is the first tablet dissolution testing instrument from Pharma test
featuring 14 full size stirred vessel positions. The vessels are arranged in a two times 6+1
configuration. This way not only your samples but also the Standard or Reference Media will be
heated and stirred by the instrument. In addition, PTWS 1420 features two additional heated full-
size vessels to store the replacement Media for Systems including an auto, Sampler. This way also
the replacement Media, which is filled into the vessels after Sampling, always has the same
Temperature as the Test Media – Eliminating any influence on the Dissolution Test due to the
refilling of Cold Media. The 14+2 vessel design of PTWS 1420 makes this instrument an excellent
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The upper drive is motorized and electronically controlled it offers Eight programmable positions:
an upper cleaning and instrument qualification position and lower working positions are
programmable depending on the type of Stirring Tool used. The upper position offers ideal access
to the stirring Tools and Vessels for a change of tools and cleaning steps between the Dissolution
tests. The motorized drive head lifting mechanism is positioned in a way so that the tool shafts are
always kept parallel and at a 90° Angle to the vessel walls when in the working position.
Dissolution Method Vessels are usually either partially immersed in a Water Bath solution or
heated by a jacket. A device is used on the intravascular solution for a predetermined period
which depends on the method of Drug being examined. The intravascular melting medium is
P Digital Ultrasonic Cleaner, Versatile with dual Frequency and Variable Power
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Figure ( 9 ) Ultrasonic Bath
The El masonic Ultrasonic Cleaner is considerably more Powerful than conventional Ultrasonic
units. If full Power is too strong, the Power is variable from 30-100% in 10% increments.
Temperature is adjustable from 30°C to 80°C; the Timer can be set from 1-60 minutes or for
continuous operation. The unit turns off Automatically after 12 hours of continuous operation for
safety. All models have a rear drain with a convenient side valve.(4)
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1. Liquid Chromatography (LC) is a Separation technique used in many different areas to aid
various detection modes have been widely used for the sensitive and selective
samples and their dosage forms. A completely new system design with advanced
which has evolved from High Performance Liquid Chromatography. The application of LC
Methods to Drug analysis introduces a Powerful tool for therapeutic Drug monitoring as
Separated during Chromatography) takes place, it can be Solid, Gel, or Solid Liquid
combination (7) .
Chromatography HPLC
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4.6.1 Parts of HPLC
2. Degasser
4. Injector
5. Column
6. Detector
7. Recoder
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The Pump delivers the Mobile Phase at a controlled flow rate. Air can easily dissolve in the
Mobile Phase under the standard Atmospheric Pressure in which we live in. If the Mobile Phase
contains air Bubbles and enters the delivery Pump, troubles such as flow rate fluctuations and
baseline noise, drift may occur. The degassing Unit helps prevent this issue by removing air
Bubbles in the Mobile Phase. After the dissolved air has been removed, the Mobile Phase is
delivered to the Column. The sample injector then introduces a standard solution or sample
solution into the Mobile Phase. Temperature fluctuations can affect the Separation of compounds
in the Column. The Column is placed in a Column oven to keep the Temperature constant.
Compounds eluted from the column are detected by a detector which is placed downstream of the
Column. A workstation processes the signal from the detector to obtain a Chromatogram to
Absorbed by a substance in solution. Instrument which measures the ratio, or function of ratio, of
the intensity of two beams of Light in the UV-Visible region are called Ultraviolet-Visible
Spectrophotometer (9) .
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Figure (12): UV -Visible
Spectrophotometer Device
recorded data is available, and quantitative Spectrophotometric analysis is used to ascertain the
rapid, moderately specific, and applicable to small quantities of compounds. The fundamental law
that governs the quantitative Spectrophotometric Analysis is the Beer -Lambert Law (10) .
1. Beer’s Law: It states that the intensity of a beam of Parallel Monochromatic Radiation
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2. Lambert’s Law: It states that the intensity of a beam of Parallel Monochromatic radiation
3. Beer-Lambert Law: When beam of light is passed through a transparent cell containing a
Spectrum.
Famotidine is used as an antacid because it blocks histamine from binding to the H 2 receptors on
the surface of the stomach's acid-producing cells, which lowers the amount of gastric acid
in gastrin secretion, which in turn produces an increase in acid secretion and, ultimately, ulcers .
(11)
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Figure(15 ) : Simple Picture of Famodar
The mobile phase consisted of a mixture of 84 % ammonium acetate buffer (pH 2.9) and 16%
acetonitrile. The buffer was prepared by mixing 95% acetic acid solution (0.5%) and 5%
ammonium acetate solution (0.2%) The mobile phase was degassed by passing it through a 0.45
mm membrane filter and pumped at a flow rate of 1.5 ml/min. The effluent was monitored at a
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wavelength of 254 nm. The range was set at 0.01 AUFS. The chart speed was 1 mm/min. The
Stock standard solutions of famotidine (2 mg/ml) and salicylic acid (0.3 mg/ml) were prepared in
methanol. Working standard solution of famotidine (100 mg/ml) and salicylic acid (300 mg/ml)
were used. Four standard solutions of famotidine 1, 2.5, 5.0, and 10 (mg/ml) were prepared by
mixing 5, 12.5, 25, and 50 ml, respectively of the working standard solution of famotidine and
50 ml of the working standard solution of salicylic acid in a microcentrifuge tube the mixture
was diluted to 500 ml with methanol and vortexed for 30 seconds. The solutions remained stable
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Six tablets of famotidine (40 mg, Pepcidin R, batch number 35200 M, Merck Sharp and Dohme,
Haarlem, Netherlands) were separately weighed. Each tablet was transferred to a 100 ml glass-
temperature. To the suspension sufficient dimethylformamide was added to produce 100 ml.
After filtration, an aliquot was withdrawn and treated as outlined under test solutions before
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6. Pamol Extra Tablet
A pain reliever drug that also contains caffeine, which acts as a central nervous system
stimulant and lessens fatigue, as well as paracetamol, an antipyretic that works by inhibiting
the body's cyclooxygenase enzyme. The caffeine boosts paracetamol's ability to relieve pain
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Prepare 0.01M Pentane sulfonic acid sodium salt in a mixture of 22 volumes of methanol
and 78 volumes of distilled water and 7 volumes of acetonitrile. Adjust pH to 2.8 + 0.05
with 2M Hydrochloric acid Filter through nylon membrane filter having a pore size of 0.45
µm Sonicate to degas.
volumetric flask, add 80 ml diluent, sonicate for 10 minutes and dilute to volume with
diluent.
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Transfer an amount of Paracetamol working standard equivalent to 23,1 mg to a 100 ml
volumetric flask, add 70 ml diluent, sonicate for 10 minutes, dilute to volume with diluent
Weigh and finely powder not less than 10 tablets. Transfer an amount of powder equivalent
to 231 mg Paracetamol to a 200 ml volumetric flask, add 140 ml diluent, sonicate for 20
minutes, dilute to volume with diluent, dilute 5 ml of this solution to 25 ml. Filter through
7. Diapride Tablets
It lowers blood sugar by stimulating insulin secretion from the pancreas, and this effect depends
on the performance of beta cells in the islets of the pancreas. The mechanism by which
tolbutamide lowers glucose in the long term is not understood. Chronic use in patients with type
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2 diabetes, and the hypoglycemic effect, persists despite the gradual decrease in the insulin
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Figure (22): Chemical Structure of Glimepiride
Prepare a mixture of Methanolic glacial acetic acid ( 1 ml Glacial Acetic acid in 1L Methanol ) ,
Acetonitrile , and Distilled Water ( 275 : 70 : 200 ) ml respectively . Pass the Mobile Phase
through a nylon membrane filter having a pore size 0.45 µm and degas.
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7.1.2 Buffer Preparation:
pH (7.4) Dissolve 13.6g of KH₂PO4 in 21. distilled water, add 2.7g NaOH then adjust the pH to
7.1.3 Diluent:
Prepare a mixture of Buffer pH 7.4 and Methanol (1000: 4000 ) ml respectively . Pass the diluent
through a nylon membrane filter having a pore size 0.45 μm and degas.
Weigh and transfer an amount of Glimepiride working standard. equivalent 20 mg into a 100 ml
volumetric flask, add about 80 ml of diluent , sonicate for 30 minutes at 45 ° C , dilute to volume
with diluent , and mix . Transfer 5 ml of this solution to a 100 ml volumetric flask, dilute to
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Weigh and transfer 5 tablets to 100 ml volumetric flask. Add about 80 ml diluent and shake, until
complete disintegration of tablets , then sonicate for 30 min at 45 ° C . Dilute to volume with
diluent and mix. Filter the solution, then transfer 5 ml of filtrate to 50 ml volumetric flask , dilute
8. Vitadad D3 Capsules
The Natural form of Vitamin D, known as cholecalciferol in science, is Vitamin D3. For Calcium
to function properly in the body and to be absorbed from the stomach, Cholecalciferol, a form of
Vitamin D, is necessary.(13)
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Figure (24): Chemical Structure of Cholecalciferol
Adjust the pH value for 500 ml distilled water using orthophosphoric acid 85 % to pH 2.6 0.05 .
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8.1.2 0.05 M Sodium Phosphate Buffer:
Dissolve 6.9 g of monobasic Sodium Phosphate monohydrate in 1000 ml Distilled water, adjust
Mix buffer, acetonitrile, tetrahydrofuran and methanol in the ration (200: 400: 400: 400)
Dissolve 8.9 g of ascorbic acid and 10 g of Triton in 1000 ml. of 0.05 M sodium phosphate
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8.3 Standard Preparation:
Weigh and transfer an amount of Cholecalciferol oily working standard equivalent to 110000 IU
volume with Acetonitrile and mix . Dilute 5 ml from this solution to 100 ml volumetric flask,
Place 900 ml of dissolution media in each vessel of the dissolution apparatus and assemble the
apparatus.
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References
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3. The MultiTest 50 can be connected to PC software for 21 CFR, Part 11 compliant electronic
data management. Measured results and test reports are collected in a database and can be
4. Gumustas, Mehmet; Kurbanoglu, Sevinc; Uslu, Bengi; Ozkan, Sibel A. (2013). UPLC versus
554–569. doi:10.2478/s11532-011-0161-0
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7. Davidson AG (2002) Ultraviolet-visible absorption spectrophotometry. In BeckettAH,
Stenlake JB, (4thedn), Practical Pharmaceutical chemistry. CBS Publishers and distributors, New
Delhi, 275-278
8. Abeer Fauzi Al-Rubaye1 , Imad Hadi Hameed2* , Mohanad Jawad Kadhim3 1Department of
Biology, College of Science for women, University of Babylon, Iraq 2College of Nursing,
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(2017). Assessing subacute mild traumatic brain injury with a portable virtual reality balance
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13. Webmd website. VITAMIN D3 Tablet - Uses, Side Effects, and More. Retrieved on the 29th
of January, 2022.
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