Ppt Farmasi.ppt

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 Quality Analysis Preparation

Formation

Total quality control of drugs

New drug discovery and development

Clinical use Manufacture process

Distribution

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 in plasma and urine

NH2 O H2N S O

NH2 + H2N

NH2

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 : GLP : GSP : GCP : AQC :

Good Manufacturing Practices Good Laboratory Practices Good Supply Practices Good Clinical Practices Analytical Quality Control

Requirements Chemical Structure （Functional Group）

Analytical Method

Physical and Chemical Properties

Reaction Mechanism