SOP for Selection Criteria and Its Procedure before Dissolution Profile Study : Pharmaceutical Guidelines

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SOP for Selection Criteria and Its Procedure before Dissolution Profile Study

Standard operating procedure for the selection criteria and its procedure before dissolution profile study.

1.0 OBJECTIVE

To lay down the guideline for the selection criteria and its procedure before dissolution profile study.

2.0 SCOPE

This procedure is applicable to all immediately released tablet dosage form, which is produced after changes with respect to either process, equipment component or composition.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant/Executive
3.2 Checking: Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Carry out dissolution testing for first three batches after changes.
5.2 Analyse 12 units of each batch for dissolution testing.
5.3 Set the dissolution parameters as follows.
Medium :- 1000 ml 0.0001N HCl
Time :- 15 minutes
Apparatus :- USP Apparatus –2 (Paddle)
RPM :- 50 RPM
5.4 Limit of dissolution Not less than 90%.
5.5 Prepare the report as per annexure-I.
5.6 If results of dissolution found less than 90%, perform the dissolution profile as per the respective method of analysis of that particular product.

6.0 ABBREVIATIONS

6.1 % = Percentage
6.2 RPM = Revolution per minute
6.3 HCl = Hydrochloric acid
6.4 ml = millilitre

ANNEXURE-I
Q.C. DEPARTMENT
Page No. 1 of 2
Name of product     :- ____________________________________________
Type of change       :- _____________________________________________
Batch No.                :- _____________________________________________
Date of analyses     :- _____________________________________________
SET-1
Dissolution parameters  :-

Instrument ID. No.
Medium
Time
Apparatus
RPM
:- 900 ml 0.1 N  HCl
:- 15 minutes
:- USP Apparatus-2(Paddle)
:- 50 RPM
Dissolution test 
apparatus
HPLC/U.V
Balance

:- _____________
:- _____________
:- _____________
Standard Preparation :-
Sample Preparation :-
Std Area (For HPLC )                                                                Std. Abs. (For UV)
(1)     ___________                                                                      _______________
(2)     ___________                                 
(3)     ___________                                 
(4)     ___________                                 
(5)     ___________ 
Mean :- ___________                          
           Calculation:


Tab. No.
Test Area/Absorbance
% of label
1
2
3
4
5
6
                                                     Mean :
[ Acceptance criteria NLT 90%]

Analyst :                                                                                                 Checked by:

Page No. 2 of 2
SET-2
Dissolution parameters  :-

Instrument ID. No.
Medium
Time
Apparatus
RPM
:- 900 ml 0.1 N  HCl
:- 15 minutes
:- USP Apparatus-2(Paddle)
:- 50 RPM
Dissolution test apparatus
HPLC/U.V
Balance

:- _____________
:- _____________
:- _____________
Standard Preparation :-
Sample Preparation :-
Std Area (For HPLC )                                                               Std. Abs. (For UV)
(1)___________                                                                           _______________
(2)___________                                 
(3)___________                                 
(4)___________                                  
(5)____________
Mean :- ___________                          
           Calculation:


Tab. No.
Test Area/Absorbance
% of label
1
2
3
4
5
6
                                                             Mean :
[ Acceptance criteria NLT 90%]

Analyst :                                                                                                 Checked by :

Conclusion :

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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