Test solution and volumetric solution; Purpose
The tenacity of this procedure is to describe procedure for preparation & handling of test solution and volumetric solution.
Test solution and volumetric solution; Scope
This SOP is valid for preparation of chemical reagent in Quality Control Laboratory at XX Pharmaceuticals Ltd.
Definitions
N/A
Responsibilities
The roles and responsibility is as follows
Officer/Executive/ Sr. Executive, Quality Control
- To confirm tests are performed with correct reagent as specified in method.
- To confirm record of reagent preparation in the work sheet.
- To confirm correct storage of reagent.
- To confirm use of reagent within the shelf life.
- To confirm reagents are retained until test results are approved.
- To confirm use of log book.
Assistant Manager, Quality Control
- To ensure reagents are in place and controlled.
- To assess & disposition of expired reagent.
- To maintain record.
- To incorporate sound technical knowledge.
Head of Quality Assurance
- To ensure the overall implementation of the SOP.
- Take initiative to approval of the SOP.
Procedure
Precaution(s):
- Wear protective clothing, gloves and goggles. Avoid contact with skin, eyes & clothing & inhalation of vapor.
- Use a fume hood while preparing solutions.
- Read label instructions of reagent container for any special precaution.
General
- For solution preparation use purified water & analytical grade reagents & chemicals.
- Prepare solution as per respective approved worksheet.
- Calculate expiry date of solutions from date of preparation.
- Check the following things before preparation of any solution.
- Glassware being used is clean & dried.
- Required reagents are available.
- Required instruments are calibrated.
- Wear suitable safety appliances while making concentrated solutions of acid & alkali/any hazardous chemicals/substances.
General guideline for the preparation of Test Solution
- Enter details in test solution preparation register (as per Annexure-I)
- Assign sequential reference number as below:
- g.TS-001/09/XX
- Where, TS is the abbreviation of Test Solution
- 001 is the sequential number
- / is separator
- 09 is the month of preparation (September)
- XX is last two digits of year 20XX
- Affix respective label on container as per Annexure-III.
- Expiry date of test solutions will be 06 months or as per mentioned in respective worksheet. During usage, any change in physical properties of the solution identified then discard it.
- If a solution is directed to prepare “fresh” then it must be prepared on the same day of use
- Discard the excess solution after expiry/ usage by diluting the solution with doubled quantity of water & then drain it into the drainage, and & entry on the respective worksheet & register.
General guideline for the preparation of volumetric solution
- Analyst shall prepare all type of volumetric solutions as per respective worksheet.
- Enter details in volumetric solution preparation register (as per Annexure-II)
- Assign sequential reference number as below:
- g.VS001-001/08/XX
- Where, VS001 is the code no. of 0.1 M Ammonium thiocyanate VS
- 001 is the sequential number
- / is separator
- 09 is the month of preparation (August)
- XX is last two digits of year 20XX
- Affix respective label on the container as per Annexure-IV.
- Volumetric solutions and standard solution for limit test must not be store for more than three months. If during usage any change in physical properties of the solution identified then discard the solution.
- Where stabilization time is not mentioned, stabilize solution for one hour before standardization.
- Carry out standardization & calculate factor of the solution twice & RSD of two results must be within 0.2%
- Find out the mean factor, which will be within ±5.0% of the labeled factor.
- If factor of prepared solution identified more than ±5.0% variation, do the necessary dilutions/weight adjustments and carry out re-standardization. Report the factor upto four digits after decimal.
- Solution should be re-standardized in 1 month +7 days interval. In case, where extraneous matters, layer separation or hazy solution observed then discard the solution.
Assign re-standardization reference number as below
e.g. Reference No./R1
Where, Reference No. of the volumetric solution subjected to re-standardization
/ is separator
R1 is re-standardization for first time (e.g. R1, R2…..)
Store all the solutions in cleaned dry containers & use amber color containers for light sensitive solutions.
Reject excess solution after expiry/ usage by diluting the solution with doubled quantity of water and then drain it into the drainage, and make entry on the respective worksheet & specific register.
Download all Annexure Here
Annexure I Test Solution Preparation Register
Annexure II Volumetric Solution Preparation and Standardization Register
Annexure III & IV Label for Test Solution & Label for Volumetric Solutions