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Sources of Impurities

This document discusses sources of impurities in pharmaceuticals. It defines key terms like pharmaceutical chemistry, impurities, official compounds, and pharmacopoeia. It explains that impurities can come from raw materials, reagents used in manufacturing, atmospheric contamination during production, storage conditions, and accidental or deliberate adulteration. The effects of impurities can include toxicity, lowered therapeutic activity, instability of the compound, and making the substance unhygienic. Tests for purity include examining the color, odor, taste, physicochemical properties, ash value, and testing for organic impurities.

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Mohamed Babiker Suliman
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1K views3 pages

Sources of Impurities

This document discusses sources of impurities in pharmaceuticals. It defines key terms like pharmaceutical chemistry, impurities, official compounds, and pharmacopoeia. It explains that impurities can come from raw materials, reagents used in manufacturing, atmospheric contamination during production, storage conditions, and accidental or deliberate adulteration. The effects of impurities can include toxicity, lowered therapeutic activity, instability of the compound, and making the substance unhygienic. Tests for purity include examining the color, odor, taste, physicochemical properties, ash value, and testing for organic impurities.

Uploaded by

Mohamed Babiker Suliman
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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org

Sources of impurities
Objective
At the end of this lecture, student will be able to

• Define the terms pharmaceutical chemistry, impurities, official compounds and pharmacopoeia

• Explain the sources of impurities and their effect in pharmaceuticals

• List out tests for purity

Definitions
• Pharmaceutical Inorganic Chemistry--- is the science that makes use of laws of chemistry to study inorganic
substances as drugs …

• Official compound ---- medicinal substances + pharmaceutical aids included in the monograph of latest edition of
pharmacopoeia

• Pharmacopoeia---directions and requirements for the preparation of medicine

• Monograph-----complete description of a specific pharmaceutical…

Title, Formula

Category, Dose

Description, Solubility

pH

Limit test

Assay

Storage

• Pure compound - free from foreign matter

• Impure compound- not free from foreign matter

• Cannot prepare a pure compound

• Can limit the amount

• Drug – Active Pharmaceutical Ingredient (API)

Effect of Impurities
• Having toxic effect - Lead and arsenic

• Lower the therapeutic activity - Ferrous sulphate- ferric sulphate

• Affect the stability of compound - Digitalis

• In compactable with other substance

• Technical difficulties in the use of substance

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KOH + I2 KIO 3 + H2O + KI

KIO 3 + 3C 3CO + KI

• Make the substance unhygienic

Sources of Impurities
• Raw materials employed in the manufacturing of the pharmaceutical substance

• Rock salt - preparation of sodium chloride is contaminated with calcium and magnesium chlorides

• Barium and magnesium impurities - calcium minerals

• Reagents used in manufacturing process-- not completely removed

• Method of Manufacture ---

 Reagents employed in the manufacturing process

 Reagents used to eliminate other impurities

 Solvents

 Reaction vessels

• Chemical process used in the manufacture

• Atmospheric contamination during the manufacturing process

2NaOH + CO2 Na2CO3 + H2O

• Manufacturing hazards

Contamination from the particulate matter

Cross-contamination of the product

Errors in the packaging

Microbial contamination

• Storage condition

Chemical instability

Reaction with container materials

Filthy

Temperature

• Accidental substitution or deliberate adulteration

Spurious material

Useless material

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Test for purity


• Colour, odour and taste

• Physico-chemical constants

• Acidity, alkalinity and pH

• Insoluble constituent

• Ash value

• Organic impurities

Summary
• Pharmaceutical chemistry deals with inorganic drugs, their preparation, chemical nature, and influence on organism

• Pure compounds are free from foreign matter

• Impure compounds contains varying amounts of foreign matter

• Pharmacopoeia is monographs of drugs

• Effect of impurities

Arsenic and lead are harmful impurities

Impurities lower the therapeutic activity

Affects stability of substance

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