Pharmaceutical analysis

Definition
Pharmaceutical analysis is an
applied science dealing with the
establishment and development
of quality control methods of
drugs and their preparations.
 Quality Control
Drugs are special products used for
prevention ,therapy and diagnosis
of diseases, and for promotion of the
functionality of human body.
Quality control and analysis of drugs
are very important means to guarantee
their safe and effective use.
Methods and Techniques
Chemical analytical method
Spectroscopy
Chromatography
Biochemical method
Biological method
 Drugs Development & Control
an important part of pharmaceutics
Discovery Medicinal
Chemistry
pharmacology Activity

pharmaceutical
Analysis
Quality

Preparation Formation
 Total quality control of drugs

New drug
discovery
and Clinical use
development
Manufacture Distribution
process
To supply analytical methods for the
development of new drugs
Example： Drug screening
Structure elucidation
Manufacture process

in-process reaction analysis

in-process particle analysis

Distribution Store
Transport
Market
Drugs in Use
Therapeutic Drug Monitoring
Pharmacokinetics
Pharmacodynetics
Drug Abuse
Overdosage
Analytical Toxicology
Drugs in Sport(Doping Control)
•Therapeutic Drug Monitoring
Determination concentration of digoxin
in plasma TDM
•Pharmacokinetics
Research and development of new drug
NH2
O
H2N S N N NH2
O
Determined NH2
in plasma O
and urine H2N S NH2 + H2N NH2
O
 Pharmaceutical analysis is a
comprehensive applied analytical
science that uses the classical and
modern analytical measures to
study the property of drugs, to
plan the drug standards, and
to control the quality of drugs.
• Pharmacokinetics and
Bioavailability
absorption
distribution
metabolism biotransformation
excretion
• New Techniques
automatization
miniaturization
high sensitive
hyphenation techniques
The general procedure
of drug analysis

Sampling Identification

Limit Test

Reporting Assay
 Sampling
 Identification
Identification test is a means to
confirm the identity of drug (true
or false).
general identification test
specific identification test
 Limit Test
Detect impurities in drugs.
Assay
the content determination of
drugs
assay of potency

 Reporting
 System & Certification of
drug’s total quality control
GMP : Good Manufacturing Practices
GLP : Good Laboratory Practices
GSP : Good Supply Practices
GCP : Good Clinical Practices
AQC : Analytical Quality Control
Requirements
Chemical
Physical and
Structure
Chemical
（Functional
Properties
Group）

Analytical Reaction
Method Mechanism