OBJECTIVE:
To describe the procedure for Preparation of test solutions, indicator solutions and limit test standard solutions.
SCOPE:
This SOP is applicable to procedure for Preparation of test solutions, indicator solutions and limit test standard solutions.
RESPONSIBILITY:
- Executive/Designee Quality Control: responsible to prepare the test solutions, indicator solutions and limit test standard solution.
- Head QC: responsible for ensuring the compliance of SOP.
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
ABOUT TEST SOLUTIONS, INDICATOR SOLUTIONS AND LIMIT TEST STANDARD SOLUTIONS
In pharmaceutical analysis, test solutions are reagents prepared for specific analytical procedures to determine the quality, purity, or strength of a substance. They react with the sample under defined conditions, producing a measurable change. Indicator solutions are specialized test solutions that exhibit a distinct color change in response to a particular chemical condition, such as a change in pH during a titration or the presence of a specific ion, signaling the endpoint of a reaction. Limit test standard solutions, on the other hand, are accurately prepared solutions containing a known concentration of an impurity. These are crucial for limit tests, which are semi-quantitative methods used to ensure that the amount of a specified impurity in a pharmaceutical substance does not exceed an acceptable limit by comparing the reaction of the sample to that of the standard.
PROCEDURE:
PREPARATION OF TEST SOLUTIONS:
For all preparations of test solutions use purified water and Analytical Grade chemicals.Prepare the solutions as per the procedures given in general test procedures.
Store the solutions in clean dry bottles at room temperature.
Note: Store light sensitive solutions in amber colour bottles
A reference number shall represent all test solutions. The solution prepared frequently shall bear an AR number.
Label the bottles as per the Format-I (Test solution label).
All test solutions should be used within 3 months from the date of preparation.
Fresh Test solution shall be prepared within 5 days on or before the ‘Valid Up to’ date.
PROCEDURE FOR ISSUANCE AND IN-HOUSE NUMBERING OF THE HPLC COLUMN:
A reference number shall represent each indicator solutions. Ex: For phenolphthalein indicator solution the reference number shall be QC/IS/01.
where QC is Department code
IS indicates indicator solution
and 01 is the reference number.
The solution prepared frequently shall bear an AR number. Eg: Phenolphthalein indicator solution initially shall have a number QC/IS/01/2801
where
QC is department code
IS is indicator solution
01 reference number
‘28’ represents the year
and ‘01’ represents the serial number which shall be a continuous number i.e.., 02, 03,…and so on.
Label the indicator solutions as per the Format-II (Label for indicator solution).
All indicator solutions should be used within 6 months from the date of preparation.
Ready to use indicators does not require any preparation. They shall be used directly after checking the sensitivity given in general test procedures. These solutions should be used within 12 months from the date opened.
PROCEDURE FOR LIMIT TEST STANDARD SOLUTIONS:
Follow the procedure described in test solutions.
Proportionately smaller or larger quantities of chemicals shall be weighed accurately, provided the measurement is made with at least equivalent accuracy and provide any subsequent steps, such as dilutions are adjusted to yield concentrations, equivalent to those intended solutions.
A reference number shall represent each Limit Test solution. Ex: For Lead standard solution the reference number shall be QC/LS/01
where
QC is Department code
LS is limit test standard
and 01 is the reference number.
The solution prepared frequently shall bear an AR number. Ex: Lead standard solution initially shall have a number QC/LS/01/2801
Where
QC is Department code
LS is limit test standard
01 is the reference number
‘28’ represents the year
and ‘01’ represents the serial number which shall be a continuous number i.e., 02, 03…. And so on.
Label the solution as per the Format-III (Label for limit test standard solution)
Specify the Concentration of the solution on the label.
All limit test standard solutions should be used within three months from the date of preparation.
Fresh Limit Test solutions shall be prepared within 5 days on or before the ‘Valid Up to’ date.
Click the link to download word file copy of this document:
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REFERENCES:
Not Applicable
ANNEXURES:
| ANNEXURE NO. | TITLE OF ANNEXURE |
| Annexure-I | Label for test solution |
| Annexure-II | Label for indicator solution |
| Annexure-III | Label for Limit Test solution |
| Annexure-IV | Preparation record for Test solution, Indicator Solution and Limit Test Standard solution |
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Master Copy : Quality Assurance Department
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Quality Control
ABBREVIATIONS:
| No. | : | Number |
| COA | : | Certificate Of Analysis |
| SOP | : | Standard Operating Procedure |
| QC | : | Quality Control |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
Annexure-I
LABEL FOR TEST SOLUTION
Annexure-II
LABEL FOR INDICATOR SOLUTION
Annexure-III
LABEL FOR LIMIT TEST SOLUTION
Annexure-IV
PREPARATION RECORD FOR TEST SOLUTION, INDICATOR SOLUTION AND LIMIT TEST STANDARD SOLUTION
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/preparation-of-test-solutions-indicator-solutions-and-limit-test-standard-solutions/
