SOP for 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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