SOP on stability study of volumetric solution
To lay down a procedure for Carrying out stability studies of volumetric solutions
Scope of SOP on stability study of volumetric solution :
This Standard Operating Procedure is applicable to the Quality Control Department followed at pharmaceutical company name with the 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 1st week on alternate days i.e.3rd.5th,and 7th day of 1st day standardization.
Standardization shall be done after three days in 2nd and 3rd week i.e.10th, 13th and 16th day of 1st
After that standardization shall be done once in week for three weeks i.e. 23rd,30th and 37th day of 1st
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. 1st day Normality /Molarity.
If solution does not meet criteria on 3rd, 5th, 7th or 10th day then shelf life shall be considered one day.
If solution does not meet criteria up to 10 days and does not meet on 13th or 16th day then shelf life shall be considered 7days.
If solution does not meet criteria up to 16 days and does not meet on 23rd or 30th day then shelf life shall be considered 15 days.
If solution does not meet criteria up to 30 days and does not meet on 37th 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
| Date | Revision Number |
Reason for Revision |
| – | 00 | New SOP |
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.: | ||||
| Day | Normality/
Molarity |
Standardized By | Checked By
|
Remark |
| 1st day | ||||
| 3rd day | ||||
| 5th day | ||||
| 7th day | ||||
| 10th day | ||||
| 13th day | ||||
| 16th day | ||||
| 23rd day | ||||
| 30thday | ||||
| 37th day | ||||
| Prepared By / Date: Checked By / Date: | ||||
Annexure-II
Summary Sheet of Stability Study of Volumetric Solution
| Name of volumetric Solution: | |||
| Days | Volumetric Solution No.:S-V1/3 | ||
| Normality/
Molarity |
Standardized
By/ Date |
Checked
By/ Date |
|
| 1st day | |||
| 3rd day | |||
| 5th day | |||
| 7th day | |||
| 10th day | |||
| 13th day | |||
| 16th day | |||
| 23rdday | |||
| 30th day | |||||||||
| 37th day | |||||||||
| Prepared By / Date: Checked By / Date: | |||||||||
| Remark if Any: | |||||||||
| Conclusion:
Authorized 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
| Preparation Procedure of Volumetric Solution | |
| Name of Volumetric Solution: B.No.of Chemical / Reagent:
Make: Procedure: |
|
| Prepared By / Date: | Checked By / Date : |
| STANDARDIZATION
(1st Day,3rd day,5th day,7th day,10th day,13th day,16th day,23rd day,30th day ,37th day ) |
||||||||||
| Reagent name: Lot No: | ||||||||||
| Weight (1) | Titer Volume (1) | Weight (2) | Titer Volume (2) | Weight (3) | Titer Volume (3) | |||||
| Calculation 1:
Calculation 2: Calculation 3: |
||||||||||
| Molarity / Normality | RSD (NMT 0.2%) | |||||||||
| 1 | 2 | 3 | Average |
|
||||||
| ID.No. Of Volumetric Solution : Volumetric Solution No.: | ||||||||||
| Standardization By/Date: | Checked By /Date: | |||||||||
Annexure -V
Verification of abnormal result
| STANDARDIZATION (…………………… Day) Analyst 1st | ||||||||||
| Name of Chemical /Reagent: Lot No.: | ||||||||||
| Weight (1) | Titer Volume (1) | Weight (2) | Titer Volume (2) | Weight (3) | Titer Volume (3) | |||||
| Calculation 1:
Calculation 2 Calculation 3: |
||||||||||
| Molarity /Normality | RSD
(NMT 0.2%) |
% Variation of average Normality / Molarity from 1st Day (NMT 0.2 %) | ||||||||
| 1 | 2 | 3 | Average | |||||||
| ID.No.of Volumetric Solution: Volumetric Solution No.: | ||||||||||
| Standardized By/Date: | Checked By/Date: | |||||||||
| STANDARDIZATION (…………………… Day) Analyst 2nd | ||||||||||
| Name of Chemical /Reagent: Lot No.: | ||||||||||
| Weight (1) | Titer Volume (1) | Weight (2) | Titer Volume (2) | Weight (3) | Titer Volume (3) | |||||
| Calculation 1:
Calculation 2: Calculation 3: |
||||||||||
| Molarity /Normality | RSD
(NMT 0.2%) |
% variation of average Normality /Molarity from 1st Normality / Molarity
(NMT 0.2 %) |
||||||||
| 1 | 2 | 3 | Average | |||||||
| ID.No.of Volumetric Solution: Volumetric Solution No.: | ||||||||||
| Standardized By/Date: | Checked By/Date: | |||||||||
| Average of Six normality / Molarity :
Conclusion: Checked By/Date: |
||||||||||
