Various Parameters dealing with the Chemistry, Synthesis, Sale and consumption, Manufacturers and testing methods of Paracetamol drug in brief.

1. A REPORT ON
PARACETAMOL
Guided by: Presented by:
Dr. Vijender Singh Ayush Sharma

2. Objective:
 To study the quality standards of 4
different brands of paracetamol tablet.
 To perform different testing
parameters for the evaluation of
different brands of Paracetamol.

3. INTRODUCTION
 Paracetamol synthesized by Harmon
Nothrop in 1878, also known as
acetaminophen is used to treat pain and
fever.
 It is also used in treatment of Headache,
Toothache, lower back pain and
menstrual pain.
 It is a weak inhibitor of PG synthesis of
COX 1 and COX 2 cell systems.
 Overdose may lead to hepatic failure,
metabolic acidosis and hepatocellular
encephalopathy.

4. CHEMISTRY
 Paracetamol is an aromatic compound
containing an -OH group and –CONHR
group.
 Paracetamol is prepared from phenol in a 3
step process:
 1. Nitration
 2. Reduction
 3. Formation of Amide.
 The presence of activating group makes the
bezene ring highly reactive towards
electrophilic aromatic substitution reaction.

5. SYNTHESIS
1. Nitration of Phenol 2. Reduction of Nitro to amine

6. 3. Formation of Amide

7. SALE AND CONSUMPTION
 The pharmaceutical industry in India ranks 3rd in
world terms of volume and 14th in terms of
value.
 The global paracetamol market is expected to
reach US$ 1,049.7 mn by 2022 as compared o
its valuation of US$ 900.2 mn in 2014.

8. MANUFACTURERS IN INDIA
S.N
o.
Brand Name Composition Company Packin
g
MRP Rs.
1. CALPOL Paracetamol
500mg
Glaxo smith
kline
10 9.49
2. CROCIN Paracetamol
500mg
Glaxo smith
kline
10 6.9
3. PARACIP Paracetamol
1000mg/100
ml
Cipla 100ml N.A
4. PYREXON
650
Paracetamol
650mg
Wockhardt 6 8.10
5. T- 98 TAB Paracetamol
500mg
Mankind 10 7.5
6. NICETAMOL Paracetamol
500mg
Dr. Reddy’s
Labs
10 NA

9. TESTING OF PARACETAMOL
 1. Weight Variation Test : As per U.S.P weight
variation limit for tablet having weight more than
324 mg is 5% and result shows that all 20 tablets of
4 different brands are having weight variation less
than 5% which proves that 4 brands available in
market passed official weight variation test.
 2. Friability Test : The official permissable limit
for friability is 1%. The result showsthat all 4 brands
of PCM are in pharmacopeial limits. It is performed
using Roche Friabilator.

10. Brands of PCM W1 (gm.) W2(gm.) % Friability
Paracip 0.582 0.581 0.17%
Dolo 0.599 0.597 0.33%
Calpol 0.612 0.610 0.33%
Crocin 0.584 0.583 0.17%

11. 3. Disintegration Test
 The result of disintegration test shows that all 4
different brands of PCM time for uncoated tablet.
The brand disintegration time is less than 6 minutes
which is less than the standard tion time is 37 sec.
eans it disintegrate very fast so the drug will be
available very to absorption and onset of time will be
less.
Brands of PCM Disintegration time(min.)
Paracip 4.5
Dolo 5.5
Calpol 0.37
Crocin 3.5

12. 4. Dissolution Test
 The result of dissolution study shows that 4 brands
release about 100% drug within one hour. The brand
A and D releases about 80% drug within 5 minutes
which means onset of action will be fast in these
brands. The data proves that dissolution study of
paracetamol complies pharacopoeial standards.
Brands Weight (gm.) Absorbance (AU)
Paracip 0.582 0.373
Dolo 0.599 0.780
Calpol 0.612 0.627
Crocin 0.584 0.739

13. 5. Drug Assay and HPLC testing
 The result shows that amount of PCM drug available is near to 100% means
drug available as per stated value and dosage form is in stable form.
 In the HPLC testing, the chromatogram obtained with with the test solution,
the area of any peak corresponding to 4- aminophenol is not greater than the
area of peak in the chromatogram obtained with the reference solution. In the
chromatogram obtained with the test solution peak with long retention time.
Fig 9 = A modern self contained HPLC .

14. CONCLUSION
 The quality control evaluation of 4 different brands of PCM tablets
those are available in pharmaceutical market were assessed by this
study the values were compared with standards.
 On the basis of above observation, measured sample solution at
243 nm. UV- Spectrophotometer the concentration of Paracetamol.
Calculated the content of paracetamol was not less than 80% of the
standard amount of Paracetamol. The observed percentage is
indicated that the Paracetamol is within the limit of Indian
pharmacopeia.
 This shows that all 4 brands of PCM tablets meet the
pharmacopoeial specification of different parameters.
The results of various quality control parameters for
tablets like weight variation, friability, disintegration time,
drug assay and dissolution study, HPLC testing all are in
the pharmacopoeial limits.

15. THANK YOU