Corporate Presentation

2017
Meaning of Impurities
In the scientific parlance
Unwanted chemical entity present in a confined
amount in API or FP
Differs in the chemical composition of that API or FP
Present naturally or arises during the manufacturing
process
Causes undesirable effect on the pharmaceutical
product

Corporate Presentation
2017
Sources of impurities An
overview
Unwanted chemicals in API
Unreacted reactants, intermediates, reagents or
residual solvents
A degradation product of API or formulation
By products arising during the synthesis of API or
formulation

Corporate Presentation
2017
Effects of impurities
Change the efficacy of the FP
Harmful effect on human health
Teratogenic, mutagenic and carcinogenic effects
No therapeutic role and are potentially harmful
Need to be controlled

Corporate Presentation
2017
Classification of Impurities

Synthesis related impurities

Formulation related impurities
Ageing related impurities

Corporate Presentation
2017
Synthesis related Impurities
Organic Impurities
Starting material
Intermediates
By-products
Degradation products

Inorganic Impurities
Derive from manufacturing process
Excipients
Leached from the packing material

Residual Solvents
Use of Class I, Class II, Class III and Class IV should be limited
Should be used as per ICH permissible concentration limit

Corporate Presentation
2017
Formulation Related Impurities
Dosage form impurities
Precipitation of main ingredients
Topochemical and nucleation reaction in the presence of moisture and
excipients
Method/process related impurities
Environment related impurities
Temperature
Light-UV light
Humidity

Corporate Presentation
2017
Ageing related impurities
Chemical reactions occur on ageing
Hydrolysis
Oxidation
Photolysis
Decarboxylation
Mutual interaction among ingredients on ageing
Effects of packaging material on ageing

Corporate Presentation
2017
Role of Regulatory Authorities
ICH Q3 guidelines classifies Impurities as
Organic Impurities
Inorganic Impurities
Residual Solvents
Metallic Impurities

Corporate Presentation
2017
Impurity Profiling An imperative aspect in
New Drug Development
Identification
Characterization (structure elucidation)
Isolation (Quantitative determination)

Corporate Presentation
2017
Role of a CRO (Contract Research
Organization)
Reduces the time taken to conduct a project
Reduces cost of the hiring company
No infrastructure, office space or man power required for
the hiring company
Manufacturing as per world class standards

Corporate Presentation
2017
Pharmaffiliates - A reliable and
preferred CRO partner
Pharmaffiliates, a strategic outsourcing firm located in the North Indian
state of Haryana
Facility is stretched over 40,000 sq feet of work area and expansion capacity
to 52,000 sq ft
Core team of 10 PhDs and a total strength of almost 150 employees
Independent Quality Assurance, Regulatory affairs and Supply Chain
management departments

Corporate Presentation
2017
Pharmaffiliates - A reliable and
preferred CRO partner
Over 10,000 impurity standards readily available in stock
State of art Research and Development department, with a core
team of scientists having an expertise in chemistry.
Subject matter experts, who are engaged in the synthesis of
impurities and metabolites of APIs and FPs
Identification and synthesis of degradants and impurities, that
are new and challenging
Leading manufacturers of impurity standards, Chemical
Intermediates, Drug Metabolites, Drug analogs, Analytical
Standards and reference standards worldwide
Provides Full Time Equivalent (FTE) based projects

Corporate Presentation
2017
Pharmaffiliates- A reliable and
preferred CRO partner
Majority of the impurities synthesized at are 98% pure
Available in pack sizes as small as 50mg and 25mg.
Customized pack size suiting your requirement.
Complete structure elucidation and data interpretation with
Certificate of Analysis

Corporate Presentation
2017
Pharmaffiliates- A reliable and
preferred CRO partner
Audited and accepted by USFDA and ISO 17025
One of the largest inventory holder of impurities.
Present worldwide in more than 45 countries
Complete customized solution for Pharmaceutical research
under one roof

Corporate Presentation
2017
Thank you