INTRNSHIP PPT AT RDTL GHY, ASSAM

1. PRESENTATION ON
REGIONAL DRUG TESTING
LABORATORY (RDTL)
SIX MILE, PANJABARI, GUWAHATI –
781002
BY
NITIN AGARWALLA
4TH YEAR, DEPT. OF PHARMACEUTICAL SCIENCES
ASSAM UNIVERSITY, SILCHAR( A CENTRAL UNIVERSITY )
DECEMBER,2018

2. ABOUT THE LABORATORY
 ONE OF THE FIVE NATIONAL LABORATORY OF THE GOVT. OF INDIA
FOR QUALITY CONTROL OF DRUGS & COSMETICS
 ESTABLISHED UNDER THE INDIAN DRUGS & COSMETICS ACT 1940
 FUNCTIONING UNDER ADMINISTRATIVE CONTROL OF THE DRUG
CONTROLLER GENERAL OF INDIA AND SUB-ORDINATE OFFICE UNDER
DIRECTORATE GENERAL OF HEALTH SERVICES, MINISTRY OF HEALTH
& FAMILY WELFARE
 THE LABORATORY WAS SETUP IN THE YEAR 2002 FOR ENTIRE NORTH
EASTERN STATE INCLUDING SIKKIM

3. MICROBIOLOGY SECTIONa) LAYOUT.
b) PREPARATION OF SUB-CULTURE.
C) MEDIA PREPARATION.
D) STERILITY TESTING.
E) PARTICULATE CONTAMINATION.
F) TEST FOR BACTERIAL ENDOTOXIN (BET)

4. MICROBIOLOGY SECTION
a. Layout:
b. Preparation of Sub-culture:
 For microbiological assay of B-lactum & other
antibiotics.
c. Media preparation:
 Soyabean Casein Digest Medium:
• For fungi: Incubate at 20-25*C for 14 days
• For anaerobic bacteria: Incubate at 30-35*C for 14
days.
 Fluid Thyoglycollate Medium:
• For aerobic bacteria: Incubate at 30-35*C for 14
days growth happens in pink layer.
• For anaerobic bacteria: Incubate at 30-35*C for 14
days growth happens in yellow layer.

5. d. Sterility Testing:
 By Membrane filtration:
• Peptone water solution
• Add penicillin
• Cut filter paper into two halves
• Check the sterility for bacteria & fungi.
e. Particulate Contamination:
 Light obstruction particle count test
 By PharmSpec software
 Used for only clear solution.
f. Test for Bacterial Endotoxin (BET):
 Test is done by gel clot method
 To measure the concentration present in the sample

6. QUALITY CONTROL
a) WEIGHING
b) PH METER
c) DISINTEGRATION TEST
d) DISSOLUTION TEST
e) INFRARED SPECTROSCOPY
f) UV-VIS SPECTROSCOPY
g) HPLC

7. A) WEIGHING For tablets:
 Weigh 20 tablets individually.
 Calculate the average weight.
 Not more than 2 tablets can
deviate from average weight of
the particular % deviation
 For capsules:
 Weigh 20 capsules.
 Remove the content from the
capsule shell.
 Weigh the capsule shell of
each capsule.
 Calculate the difference in
weight of
20 capsules & shells of 20
capsule.
 Compare with the given table.
b) pH meter:
 Used for indicating the acidity &
alkalinity of the solution.
 The pH meter measures the
difference in the electrical
potential between a pH electrode
and a reference electrode.
 It is also referred as

8. c) Disintegration test:
 Breakdown of particles into smaller pieces.
 To determine the time taken to break into
smaller pieces.
d) Dissolution Test:
 To predict the time for complete release
of the material from the dosage form.
 Two types of apparatus are used:
 Apparatus -I Paddle apparatus.
 Apparatus -II Basket apparatus.

9. E. INFRARED SPECTROSCOPY (IR):
STUDY OF ABSORPTION OF INFRARED
RADIATION.
REGIONS OF THE IR SPECTRUM:
 4000 CM−1 – 1300 CM−1
1300 CM−1 – 400 CM−1
F. UV-VIS SPECTROSCOPY:
MEASUREMENT OF THE ABSORPTION OF
MONOCHROMATIC RADIATION BY SOLUTION
OF CHEMICAL SUBSTANCES.
RANGE OF THE SPECTRUM:
ULTRAVIOLET – 190 NM TO 380 NM
VISIBLE – 380 NM TO 780 NM

10. G. HPLC:
ALSO KNOWN AS “HIGH PERFORMANCE LIQUID
CHROMATOGRAPHY.”
TO SEPARATE, IDENTIFY, AND QUANTIFY EACH COMPONENT IN
A MIXTURE.
SEPARATION OCCURS ACCORDING TO DIFFERENT FLOW RATES
OF DIFFERENT COMPONENTS.
HPLC MACHINE COMPOSED OF:
SOLVENT RESERVOIR (MOBILE PHASE)
PUMP
SAMPLE INJECTOR
HPLC COLUMN-SILICA , C8
COMPUTER DATA STATION

11. CONCLUSION
INDUSTRIAL TRAINING CARRIED OUT AT RDTL PROVIDED ME
THE KNOWLEDGE OF QUALITY CONTROL DEPARTMENT &
MICROBIOLOGY SECTION THAT SHOULD BE UNDERTAKEN TO
ASSURE THE QUALITY OF FINISHED PRODUCTS.
IT IS A GOOD PROGRAMME INCLUDED IN OUR SYLLABUS &
GAVE THE DIFFERENT INFORMATION ON DIFFERENT
INSTRUMENT, APPARATUS & TESTS.
FINALLY I WOULD LIKE TO THANK ALL THE INDIVIDUALS WHO
HELPED ME DURING MY TRAINING AND GUIDED ME FOR MY
FURTHER STUDIES.

12. THANK YOU