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Pharmaceuticals and Life Sciences Presentation
Pharmaceuticals and Life Sciences Presentation
Pharmaceuticals and Life Sciences Presentation
com/
Introduction
About us
Vision and mission
Product Explanations
Documents required according to FDA rules
Who should be the contact person?
Companies
Plan of Action
Sample letter
ABOUT US
Our efforts will be to serve humanity with the power of all the scientific
knowledge available to us.
Our vision sets out the framework and objectives for the future, and
directs every one in the organization towards achieving the set goals.
Our value system, in congruence with our expertise and radical ways of
operations, has conceptualized and strengthened our taken stand, for the
vision and goals at every step of our business process.
We believe in creating 'the change', and embracing and adopting the same
to the best of its advantage.
Mission:
Products Explanation
Metabolites: Metabolites are the intermediate products that are formed while the
metabolic reactions takes place to form the final product
Example : 4-Hydroxypropranolol Hydrochloride
Metabolite of : Propranolol
Uses: Propanolol Hydrochloride is a beta- adrenergic receptor blocking agent ( Usually
used in the management of hypertension drugs)
Potential for drug to have longer half life and reduced/less frequent dosing
Products Explanation
Glucuronides: A glucuronide, also known as glucuronoside, is any
substance produced by linking glucuronic acid to another substance via a
glycosidic bond. The glucuronides belong to the glycosides.
Example:(R)-Propranolol -D-Glucuronide Sodium Salt
Metabolite of: Propanolol
Uses: Rac Propranolol -D-Glucuronide Sodium Salt is a metabolite of
Propranolol.
Propanolol is a non-selective beta blocker - it blocks the action of
epinephrine and norepinephrine on 1-AR and 2-AR (1- and 2adrenergic receptors, respectively).
Research has also shown that propranolol has inhibitory effects on the
norepinephrine transporter and/or stimulates norepinephrine release.
Products Explanation
Example:(1S)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butan1-amine. N-acety
Impurities Explanation
Impurities are classified as :
Organic impurities
Inorganic impurities
Residual Solvents
Organic impurities may arise during the manufacturing
process and/or storage of the new drug substance. They may
be identified or unidentified, volatile or non-volatile and
include:
Starting materials
By-Products
Intermediates
Degradation Products
Reagents, Ligands and catalyst
Impurities Explanation
Inorganic impurities may derive from the
manufacturing process. They are normally known
and identified and include:
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