PRESENTATION ON INDUSTRIAL TRAINING

Submitted in partial fulfillment of the

Requirements for the award of the degree of

Master of Science (M.Sc.)

In

organic chemistry

Submitted by: GOR KOMAL ASHVINBHAI

Roll no: 113 Uni exam no: 439

Mentor: DR.J.J PATEL

Submitted to:

M.G. SCIENCE INSTITUTE

DEPARTMENT OF CHEMISTRY

Affiliation: Gujarat university

AHMEDABAD, GUJARAT
INTRODUCTION
MA RUTI INDUS TRI E S CA ME INTO E XI S TE NCE IN THE Y EA R 2 0 0 7 , WITH THE S O L E P URP O S E O F MA RK ING S TA R-CLA S S P RODUCTS
FO R P E OP LE FROM A LL WA L K S O F LIFE . MARUTI I NDUS TRI E S I S A N A CTIV E P HA RMACE UTICA L ING REDI E NT (A P I) CO MPA NY,
HAV I NG A CG MP FA CIL ITY LO CATE D AT A NK L E S HWA R IN THE DIS TRICT O F B HA RUCH, G UJ ARAT, I NDIA .

MA RUTI INDUS TRI E S S TRO NG LY B E LI E V E THAT WITH OUR E X CE L L E NT INFRA S TRUCTURE A ND E X TE NS IV E CHE MI CA L B US I NE S S
B A CK G RO UND, IT I S AP TLY P O S ITI O NE D FO R A P I S & INTE RME DI ATE S MA NUFA CTURING A ND O UTS OURCI NG FO R G LOB A L
P HARMA CE UTICA L & CHE MICA L INDUS TRIE S .
MA RUTI INDUS TRI E S’ CA PA B I LITI E S INCL UDE NON-I NFRI NGI NG S Y NTHE TIC RO UTE S E LE CTIO N WI TH RE S P ECT TO PATE NTS ,
P ROCE S S E S, A NA LY TI CA L VA LIDATIO N, O PTI MI ZATIO N, A ND S UCCE S S FUL S CA L E- UP FRO M B E NCH TO MA NUFA CTURI NG .
DEPARTMENTS AT MARUTI INDUSTRIES
PRODUCTION:
All operations are involved in the preparation of pharmaceutical products, from receipt of
materials, through processing, packing, labeling, to completion of the finished product.
The production follows defined procedures by approved specifications to obtain products of
desired quality.
During the whole process of production, the material is tasted at every step in the quality control
lab.

QUALITY CONTROL:
The quality control department is one of the most important departments in a pharma company.
Here various instruments are used for the analysis of the drug or say material.
Here each and every instrument is 21-CFR Part 11 Compliance, it is a Food and Drug
Administration regulation for electronic documentation and electronic signatures.
Maintaining the data records is the most important task for the quality control
department, as the products tested here are to be directly used by the living being. The
maintained data is used for future reference in terms of investigation purposes.
Every instrument has its unique ID for documentation reference.
QUALITY ASSURANCE:

A quality assurance personnel is responsible for ensuring that products and services meet the established
standards set by the company. Duties include maintaining strong overall quality control of products made by the
company adhering to reliability, performance, and customer expectation. Inspection of products is part of the job
with the obligation to report and document findings. Depending on the organization, the typical job profession for
quality assurance is a managerial role or a directorship. Quality assurance develops quality assurance standers
and company processes. creates quality measurements to track improvements in products.

SAFETY DEPARTMENT:
For any pharmaceutical company, employees are the biggest asset. The safety department works to ensure
their improved health and safety, it is important to implement and regulate an “injury-free” environment.
Set guidelines, take action, and regulate the implementation of safety measures that eliminate injuries and
incidents.
PRODUCT:
1) Chlorzoxazone:

Synonyms: 5-Chloro-2-hydroxybenzoxazole

Melting point: 189º C to 194º C

CAS No: 95-25-0

Formula: C7H4ClNO2

Molecular Weight: 169.57

Phase: crystalline solid

Odor: odorless

Water solubility: Slightly soluble

Chemical family: Heterocyclic Benzoxazole

Basic use: Muscle relaxant

Appearance: White or practically white
Structure:
CHLORZOXAZONE API
Chlorzoxazone is a centrally acting skeletal muscle relaxant indicated as an adjunct to
rest, physical therapy, and other measures for the relief of discomfort associated with
acute, painful musculoskeletal conditions. Chlorzoxazone is available in generic form.
Chlorzoxazone is available in the market with various oral administration formulations. Its
chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is as shown
above.

Shelf life: 5 years if sealed and store away from direct sunlight
Name Molecular State Method of
Raw materials used: Formula Storage

       
4- chloro- 2- aminophenol C₆H₆ClNO Crystal Drums
 

Urea CH₄N₂O Solid Bag

Acetic acid CH₃COOH Liquid Drums

Hydrochloric acid HCL Liquid Drums

Caustic lye NaOH Solid Bag

Methanol CH3OH Liquid Drums

PROCESS:
2-hydroxy chlorobenzoxazole is prepared by hydrolysis of the corresponding 2-amino-5- or 4-chloro
benzoxazole. Benzoxazole compound is also water-insoluble in nature and an aromatic organic
compound having a benzene-fused oxazole ring structure. So, during the production of this
compound, it is dissolved in organic solvents like methanol, ethanol, acetone, ethyl acetate, and
chloroform, etc These organic solvents have been used for solubilization of poorly water-soluble drugs
production. Drawbacks of organic solvents include high cost and error in the analysis due to volatility.
 
2-hydroxy chlorobenzoxazole is produced by the reaction between 2-amino-5- or 4-chloro
benzoxazole, HCl, and Urea at 115°C with constant Ph of 4.5 – 5. In this reaction, HCl is added to
solubilize 2-hydroxy chlorobenzoxazole and neutralizes the ammonia released from the reaction. Here
acetic acid is added as a buffer solution. A further solution is a centrifuge for getting a crude product
which is further purified by adsorption (decolorization) and finally, crystallization occurs in presence of
an organic solvent like methanol.4-Chloro Amino Phenol [4-CAP] is charged along with HCI, Urea,
Acetic Acid, and Water & heated to a specific elevated temperature till completion of the reaction.
 
C6H6CINO +NH2CONH2+ 2HCL → C7H4ClNO2+ 2NH4CI
INSTRUMENTS:
(1) HPLC (High-Performance Liquid Chromatography)
High-performance liquid chromatography (HPLC), formerly referred to as high- pressured liquid
chromatography, is a technique in analytical chemistry and organic 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.

(2) UV VIS SPECTROMETER

UV spectroscopy or UV-visible spectrophotometry refers to adsorption spectroscopy or reflectance
spectroscopy in part of the ultraviolet and the full, adjacent visible regions of the electromagnetic
spectrum. This means it uses light in the visible and adjacent ranges. The absorption or reflectance
in the visible range directly affects the perceived color of the chemicals involved. In this region of the
spectrum, atoms and molecules undergo electronic transitions. Absorption spectroscopy is
complementary to fluorescence spectroscopy, in that fluorescence deals with transitions of electrons
from the excited state to the ground state to the excited state.
(3) GAS CHROMATOGRAPHY
Gas chromatography (GC) is a common type of chromatography used in analytical chemistry for
separating and analyzing compounds that can be vaporized without decomposition. Typical uses of
GC include testing the purity of a particular substance or separating the different components of a
mixture. In preparative chromatography, GC can be used to prepare pure compounds from a mixture.

(4) PH METER
A pH meter is used to measure the acidity and alkalinity of a solution, or a pH meter is an electronic
device used for measuring the pH of any solution. pH Meter Calibration is required at regular intervals
or as per the defined frequency to maintain its accuracy.

(5) CONDUCTOMETER
The conductivity detectors are also used for the measurement of concentrations of electrolytes in
aqueous solutions. The molar concentration of an analyte that produces solution conductivity can be
obtained from the measured electrical resistance of the solution.
CONCLUSION:
Industrial training is very much essential for Pharmacy Students. It is also a great opportunity to acquire practical knowledge.
During my training period, in the industry, I acquired lots of experience in Pharmaceutical Production and Production
management. This will help me to clarify my theory knowledge. I hope and pray that it will help me much in my future profession.

During our training period, we had seen the various instruments and apparatus in the industry. The highly sophisticated
instruments that work precisely must be operated with intense care for optimum use. We could acquire a lot of information
regarding the latest instruments and their working procedures.

It was taught to us that, the CGMP guidelines are to be strictly followed in the industries in each and every section. The workers
were seen dealing with the active medicaments with bare hands. The quality control section was also of substandard. Due to
lots of vacancies of chemists, they did not do the basic tests of the solid dosage forms like essays, disintegration tests,
dissolution tests, etc. They are doing the same only on the paper documents, not in practice. Hence it can be said that the
authorities are not paying much importance to the quality of the products

Apart from all that, the training was very interesting with lots of things to be learned. It helped us to acquire knowledge on
punctuality, regularity, and working environments in industries. The friendly working environment in Maruti industries will remain
in our minds in near future. Hence, we can say that our goal of attending the industrial tour is fulfilled. We acknowledge the great
help of Maruti industries.
CERTIFICATE