This document summarizes a seminar presentation on impurities and stability studies. It defines impurities as any component of a drug substance that is not the defined chemical entity. Impurities are classified as organic, inorganic, or residual solvents. Organic impurities can arise from manufacturing processes or storage and include starting materials, byproducts, and degradation products. Inorganic impurities result from manufacturing and include reagents, metals, and salts. Residual solvents are volatile organic chemicals used in drug substance synthesis. The document also discusses ICH guidelines for qualifying impurities based on safety testing and provides a decision tree for conducting safety studies of drug substances.

1. KARNATAKA COLLEGE OF
PHARMACYBangalore :560064
SEMINAR ON
Impurities and Stability studies
Presented by:
Pradhuman patel
Submitted to:
Dr. C. SHREEDHAR
Professor &H.O.D
DEPT.OF PHARMACEUTIACAL ANALYSIS

2. CONTENT
1) DEFINE IMPURITIES.
2) CLASSIFICATION OF IMPURITIES IN DRUG
SUBSTANCES OR ACTIVE PHARMACEUTICAL
INGREDIENTS.
3) QUALIFICATION OF IMPURITIES AS PER ICH
GUIDELINES.

3. 1. DEFINITION
What is impurity?
Any component of the new drug substance
that is not the chemical entity defined as the
new drug substance.
or
Any component that is not the drug substance
or an excipient.

4. 2.CLASSIFICATION OF IMPURITIES
Impurities can be classified into the following
categories:
1. Organic impurities (process- and drug-related)
2. Inorganic impurities.
3. Residual solvents.

5. 1) ORGANIC IMPURITITIES :
Organic impurities can arise during the
manufacturing process and/or storage of the new
drug substance. They can be identified or
unidentified, volatile or non-volatile, and include:
• Starting materials
• By-products
• Intermediates
• Degradation products
• Reagents, ligand and catalysts

6. 2.INORGANIC IMPURITIES
Inorganic impurities can result from the
manufacturing process. They are normally known
and identified and include:
• Reagents, ligands and catalysts
• Heavy metals or other residual metals
• Inorganic salts
• Other materials (e.g., filter aids, charcoal)

7. 3. RESIDUAL SOLVENTS
• Solvents are inorganic or organic liquids used as
vehicles for the preparation of solutions or
suspensions in the synthesis of a new drug
substance.
• Residual solvents in pharmaceuticals are defined as
organic volatile chemicals that are used in the
manufacture of drug substances.

8. 3.QUALIFICATION OF IMPURITIES AS PER
ICH GUIDELINES.
• Qualification is the process of acquiring and evaluating data that
establishes the biological safety of an individual impurity or a
given impurity profile at the level(s) specified.
• The level of any impurity present in drug substance that has
been adequately tested in safety and/or clinical studies would be
considered qualified.
•Impurities that are also significant metabolites present in animal
and/or human studies are generally considered qualified.

9. .
• Quantitative results should be presented
numerically, and not in general terms such as
“complies”, “meets limit” etc.
• Below 1.0%, the results should be reported to two
decimal places (e.g., 0.06%, 0.13%); at and above
1.0%, the results should be reported to one decimal
place (e.g., 1.3%).
• Results should be rounded using conventional rules.

10. .

11. DECISION TREE FOR SAFETY STUDIES OF DRUG
SUBSTANCE

12. .
NOTES
This procedure could not applied for the drug
substances like :
 Peptide
 Oligonucleotide (genetics)
 Biological/biotechnological
 Radiopharmaceutical
 Fermentation product and semi-synthetic
products derived from, herbal products
 Crude products of animal or plant origin.

13. .REFERENCE:
1) GOOGLE(SLIDE SHARE)
2) TEXT BOOK OF PHARMACEUTICAL ANALYSIS
BY K A CONNORS.
THANK YOU 