Documentos de Académico
Documentos de Profesional
Documentos de Cultura
Product
name
Document No.
Revision No.
Supersedes
Effective date
QC-SPF-175
00
Nil
25 th July 2016
Product code
FCT188KH
Designation
Name
Prepare by
QC- Executive
Checked by
QC Vice Manager
Approve by
QA Manager
Authorized by
General Director
Page
Page 1 of 4
Signature
Date
1. APPROVAL
2. OBJECTIVE
New standard operation procedure for analys Effer Paralmax 325 to import to
Cambodia.
3.
DESCRIPTION
In the assay: UV spectrum of the sample solution corresponds to that in the standard
solution.
5. UNIFORMITY OF WEIGHT (Follow Ph. Eur. method 2.9.5)
Weigh an intact sachet. Open the sachet without losing any part of the container and
remove the contents as completely as possible. Weigh the empty container. The mass
of the contents is the difference between the weighings. Repeat the procedure with
another 19 sachets. Not more than 2 of the individual masses deviate from the
average mass by more than 10% and none deviates by more than 20%.
Product
name
Document No.
Revision No.
Supersedes
Effective date
QC-SPF-175
00
Nil
25 th July 2016
Product code
FCT188KH
Page
Page 2 of 4
6. DISINTEGRATION
Place one dose of the effervescent granules in a beaker containing 200 ml of water at
15-25 C; numerous bubbles of gas are evolved. When the evolution of gas around
the individual grains ceases, the granules have disintegrated, being either dissolved or
dispersed in the water. Repeat the operation on 5 other doses. The preparation
complies with the test if each of the 6 doses used disintegrates within 5 min.
7. RELATED SUBSTANCES (4-aminophenol)
7.1. Reagents
Column:
Flow rate:
1.2 ml/minute
Detector UV:
272 nm
Injection volume:
20 l
Mobile phase: Sodium butane sulfonate 0.01 M solution in mixture of formic acid:
methanol : purified water (0.4 15 85).
7.3. Procedure
Product
name
Document No.
Revision No.
Supersedes
Effective date
QC-SPF-175
00
Nil
25 th July 2016
Product code
FCT188KH
Page
Page 3 of 4
Inject 20 l of standard solution and the test solution into the chromatography system.
On chromatogram: Area of 4-aminophenol peak in test solution not higher than area
of 4-aminophenol in standard solution.
8. ASSAY
Standard solution: Weigh accurately about 75.0 mg paracetamol CRS into a 100 ml
volumetric flask, add 25 ml of 0.1 N sodium hydroxide and 50 ml water, shake them
carefully, dilute with water to volume. Transfer exactly 10.0 ml of this solution into a
100 ml flask, dilute with water to volume, shake them steadily. Transfer exactly 10.0
ml of this solution into a 100 ml flask, add 10 ml 0.1 N sodium hydroxide , dilute
with water to volume, shake them steadily.
Test solution: Transfer an accurately weighed quantity of the powdered granule
containing about 150.0 mg of paracetamol to 100 ml volumetric flask, add 25 ml 0.1
N sodium hydroxide and 50 ml water, sonicate for 5 minute . Let it cool and dilute
with diluent to volume. Filter through a filter paper and leave the first of 20 ml of
filtrate. Transfer exactly 5.0 ml of this solution into a 100 ml flask, dilute with water
to volume, shake them steadily. Transfer exactly 10.0 ml of this solution into a 100 ml
flask, add 10 ml 0.1 N sodium hydroxide , dilute with water to volume, shake them
steadily.
Used 0.01 N sodium hydroxide as blank solution. Measure absorbance at 257 nm.
C 2 100
Ac mt
P
Q (%)=
At, Ac : Absorbance paracetamol in test solution, standard solution.
mc : the quantity of paracetamol CRS (mg).
Product
name
Document No.
Revision No.
Supersedes
Effective date
QC-SPF-175
00
Nil
25 th July 2016
Status
In-house
Page
Page 4 of 4