|
Drug Quality Control
and Toxicology Laboratory Department
Physicochemical Div
Toxicology Div
Microbiology Div
Pesticide Div
Physicochemical
Laboratory Division
Physicochemical laboratory
division provides test service on physical and chemical
parameters of pharmaceutical formulations. It uses USP, BP
and/or other pharmacopeial requirements to check the quality
of drugs and medical devices be it raw material or final
manufactured products pre or post marketing.
Function:
Provide testing services on
physical and chemical parameters using different analytical
techniques and procedures based on pharmacopeial or
validated procedures set or accepted by DACA.
Purpose:
Ensure that all
pharmaceutical products on the Ethiopian
market whether locally manufactured or imported
fulfilled the physical and chemical parameters of the set
requirements so that the drugs are of good quality and safe
for their intended use.
Activities:
Conducting a range of
physical and chemical tests on drug samples that are brought
for registration or post marketing surveillance.
The samples are obtained from importers through Drug
Evaluation and Registration Department, DACA or sampled
during inspection from pharmaceutical manufacturing plants,
pharmaceutical wholesalers, retail pharmacies and
distribution centers. The
division has three units:
-
Wet-chemical Analysis
-
Instrumental Analysis
and
-
Condom Testing
Some of the detailed
physical and chemical tests performed include:
-
Determination of
content and weight uniformity for tablets,
capsules and sachets
-
USP analysis of
moisture and residual solvents in bulk drugs &
formulations
-
Determination of
common anions and cations in drug
formulations and water
-
Determination of
heavy metals in drug formulations
-
Ash value
determination
-
Assaying of drug
formulations
-
Stability studies
-
Method development
and validation
-
Validation of
manufacturer’s in–house test methods (for the non-
pharmacopoeial products)
-
Conducting full
condom quality parameters
Tests currently being
carried out
Some of Laboratory Equipments and Instruments
To carry out the above mentioned activities and tests the
division is well equipped with the following apparatuses and
instruments.
Spectrophotometric Technique instruments
-
UV-Visible
Spectrophotometer (single and double beam)
-
FTIR
Spectrophotometer (2 in number)
-
Atomic
Absorption Spectrophotometer
-
Fluorescence
Spectrophotometer
-
Flame
photometer
Chromatographic technique instruments
-
High
performance liquid chromatography (6 in number)
-
Liquid
chromatography with mass spectrophotometer (LCMS)
-
High
performance Thin Layer Chromatography (HPTLC)
-
Gas
chromatography (2 in number)
-
Gas
chromatography with mass spectrophotometer (GCMS)
Others
-
Automatic titrator
-
Polarimeter
-
Particulate matter counter
-
Automated disintegration apparatus (2 in number)
-
Suppository disintegration apparatus
-
Automated dissolution apparatus
-
Manual disintegration and dissolution apparatus
-
Friability and Hardness tester
-
Moisture Analyzer
-
Melting point apparatus
-
Vicometer
-
pH meter
-
Stability Chamber
The
physicochemical Lab Division plans to offer the following
services in the near future:
-
Quality
control of medical devices
-
Quality
control of cosmetics
-
Quality
control of traditional medicines
The
physicochemical Laboratory Division has the potential to:
-
Provide
training services in the areas of analysis of medicines
- To participate
in research activities in collaboration with other
research institutions and Universities especially in
method development and validation as well as in quality
assessment
- Providing
working reference standards for local laboratories
Staff
The
laboratory currently has a total of 9 professionals and
technical staff composed of 5 Pharmacists, 1 chemist, and 3
Lab Assistant.
|
