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STANDARD TEST PROCEDURE FOR FINISH PRODUCT

Boston Vietnam Pharma JSC


No 43,No 8 Street , Vietnam Singapore
Industrial Park I, Binh Duong Province, Vietnam

Product
name

Document No.
Revision No.
Supersedes
Effective date

QC-SPF-175
00
Nil
25 th July 2016

EFFER PARALMAX 325


Status
In-house

Product code
FCT188KH

Designation

Name

Prepare by

QC- Executive

Phar. Kieu Xuan Hai

Checked by

QC Vice Manager

M.S. Ha Bao Tran

Approve by

QA Manager

Phar. Nguyen Thanh Phuc

Authorized by

General Director

Mr. Luong Dang Khoa

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

By appearance, preparations should pass the mentioned requirements.


4. IDENTIFICATION

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%.

STANDARD TEST PROCEDURE FOR FINISH PRODUCT


Boston Vietnam Pharma JSC
No 43,No 8 Street , Vietnam Singapore
Industrial Park I, Binh Duong Province, Vietnam

Product
name

Document No.
Revision No.
Supersedes
Effective date

QC-SPF-175
00
Nil
25 th July 2016

EFFER PARALMAX 325


Status
In-house

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

Formic acid PA grade.


Methanol HPLC grade.
Sodium butansulfonate HPLC grade.
7.2. The chromatography condition

Column:

C18 (250 x 4.6 mm; 5 m).

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

Standard solution: Dissolve 25 mg of 4-aminophenol in 100 ml methanol 15% (v/v).


Pipette exactly 2.0 ml into 50 ml volumetric flask, dilute with methanol 15% to
volume, shake them steadily. Filter through a 0.45 m membrane
Test solution: Weigh accurately quantity of the powdered granule containing about
1.0 g of paracetamol to 100 ml volumetric flask, add 30 ml methanol, sonicate for 5
minute. Let it cool and dilute with purified water to volume. Filter through a filter
paper and leave the first of 20 ml of filtrate then filter this solution through a 0.45 m
membrane.

STANDARD TEST PROCEDURE FOR FINISH PRODUCT


Boston Vietnam Pharma JSC
No 43,No 8 Street , Vietnam Singapore
Industrial Park I, Binh Duong Province, Vietnam

Product
name

Document No.
Revision No.
Supersedes
Effective date

QC-SPF-175
00
Nil
25 th July 2016

EFFER PARALMAX 325


Status
In-house

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

Weigh and powder 20 sachets without container, determine average mass.


8.1. Reagent

0.1 N sodium hydroxide.


8.2. Procedure

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.

Content of paracetamol (C8H9NO2) in each tablet was compared to the amount in


label, calculated on the average mass, calculated by formula:
At mc
M

C 2 100
Ac mt
P
Q (%)=
At, Ac : Absorbance paracetamol in test solution, standard solution.
mc : the quantity of paracetamol CRS (mg).

STANDARD TEST PROCEDURE FOR FINISH PRODUCT


Boston Vietnam Pharma JSC
No 43,No 8 Street , Vietnam Singapore
Industrial Park I, Binh Duong Province, Vietnam

Product
name

Document No.
Revision No.
Supersedes
Effective date

QC-SPF-175
00
Nil
25 th July 2016

EFFER PARALMAX 325


Product code
FCT188KH

Status
In-house

Page
Page 4 of 4

mt : the quantity of the powdered tablets in mg in the test solution (mg).


C : the content of paracetamol CRS (expressed as percentage w/w).
P : content paracetamol in label (mg).
M: the average weight of the sachet in mg.