SOP on stability study of volumetric solution

SOP on stability study of volumetric solution

Objective:

To lay down a procedure for Carrying out stability studies of volumetric solutions

Scope:

This Standard Operating Procedure is applicable to Quality Control Department followed at pharmaceutical company name with location

Responsibility:

QC personnel shall be responsible to follow the procedure as per SOP.

Accountability:

Department Head & QA Head shall be accountable for implementation of this SOP.

Abbreviations and Definitions:

SOP: Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.

RSD : Relative Standard Deviation

VS:Vplumetric Solution

Procedure:

Preparation, Standardization and storage of volumetric solution shall be as per SOP.

Initial standardization of volumetric solution shall be done on same day or next day as per General Test Procedure or Pharmacopoeia and maintain a record of preparation and standardization.

A sets of three volumetric solutions of unique ID.No.shall be prepared for stability study and labeled as per annexure -I.Differentiate these three volumetric solutions by assigning volumetric solution No.VS-1/3,VS-2/3,VS-3/3.

All three volumetric solutions of a set shall be standardized at intervals given below and maintain its record as per Annexure II.

Standardization shall be done in 1^st week on alternate days i.e.3^rd.5^th,and 7^th day of 1^st day standardization.

Standardization shall be done after three days in 2^nd and 3^rd week i.e.10^th, 13^th and 16^th day of 1^st

After that standardization shall be done once in week for three weeks i.e. 23^rd,30^th and 37^th day of 1^st

Record all observation in summary sheet as per Annexure.

At each interval volumetric solutions shall not differ from prescribed strength by more than 10% and the Normality/Molarity shall be determined in triplicate and RSD shall not be more than 0.2%.

Normality / Molarity at each intervals should not be differ more than 0.2 % of the initial Normality /Molarity i.e. 1^st day Normality /Molarity.

If solution does not meet criteria on 3^rd, 5th, 7th or 10^th day then shelf life shall be considered one day.

If solution does not meet criteria up to 10 days and does not meet on 13^th or 16^th day then shelf life shall be considered 7days.

If solution does not meet criteria up to 16 days and does not meet on 23^rd or 30^th day then shelf life shall be considered 15 days.

If solution does not meet criteria up to 30 days and does not meet on 37^th day then shelf life shall be considered 25 days.

If solution meets the criteria up to 37 days then self life shall be assigned one month.

If same shelf life has been obtained from all three volumetric solutions of a set then that shelf life shall be assigned to that volumetric solution. If same shelf life has not been obtained then minimum shelf life shall be given to that volumetric solution.

Interval at which one more than one solution does not meet the criteria then that solution shall be standardization for that interval by two different analysis in triplicate and average result shall be reported, If all six values meet the criteria then shelf life study shall be continued.

Discontionue the shelf life study if any value does not meet the criteria. Observation shall be recorded as per Annexure V.

Prepare a list of the shelf of volumetric solutions as per Annexure and shall be displayed in QC laboratory.

Forms and Records (Annexures)

Label OF Volumetric Solution for Stability Study – Anexure -I

Summary Sheet of stability study of Volumetric Solution -Annexure – II

List of Shelf Life of Volumetric Solution -Annexure – III

Preparation And Standardization of volumetric solution – Anexure – IV

Verification of abnormal result – Annexure -V

Distribution

Master copy – Quality Assurance

Controlled copies – Quality Assurance, Quality Control

History

 Annexure-I

Label OF Volumetric Solution for Stability Study

• Volumetric Solution of Stability Study
• Name of Volumetric Solution:
• Volumetric Solution ID No.:
• Volumetric Solution No.:
• Normality/Molarity
• Standardized By
• Day

Annexure-II

Summary Sheet of stability study of Volumetric Solution 

• Name of volumetric Solution:  
• Volumetric Solution ID No.:
• Volumetric Solution No.:Normality/MolarityStandardized
• By/ Date

Annexure – III

List of Shelf life of Volumetric Solutions

• Sr.No.
• Name of volumetric solution
• Shelf life

Annexure – IV

Preparation And Standardization of volumetric solution 

• Name of Volumetric Solution:
• B.No.of Chemical / Reagent:
• Make:
• Procedure:
• Prepared By / Date:
• Checked By / Date :

Pharma More Jobs and post Please click here