SOP for Preparation, Usage, Standardization and storage of Laboratory Reagent, Chemicals, Indicators and Volumetric solutions.
This Document describes (Standard Operating procedure) SOP for Preparation, Usage, Standardization and storage of Volumetric solutions, Laboratory Reagent, Chemicals and Indicators.
SOP for Preparation, Usage, Standardization and storage of Laboratory Reagent, Chemicals, Indicators and Volumetric solutions.
I. Purpose & Scope:
- The purpose of this SOP is to lay down the procedure for Preparation, Usage, Standardization and storage of Laboratory Reagent, Chemicals, Indicators and Volumetric solutions.
- This Standard operating procedure shall be applicable for Preparation, Usage, Standardization and storage of Laboratory Reagent, Chemicals, Indicators and Volumetric solutions.
II. Responsibilities:
- All Quality control personnel shall be responsible to follow and implement this SOP.
III : Introduction and Procedural Part :
Receipt of Reagents and Chemicals (Commercially available) :
- After receipt of Chemical and Reagent; check the chemicals against invoice for pack size and quantity received.
- Check the manufacturing and Expiry date/Month of chemicals.
- Maintain stock record for all chemicals and reagents used in the Quality Control Refer annexure I.
- Also ensure the physical condition of the container and label.
- Store the received chemicals at appropriate place as per storage requirement.
- Allot the unique serial No for the individual Reagent / Chemical procured in the Laboratory Allot the number as given below :
- For solid chemicals, allot the number as e.g. SA-001, where S indicates solid, A indicates chemical with alphabet A, like Ammonium chloride and 001 indicates the unique serial number allocated to particular chemical. Similarly for liquid chemicals, allot the number as;
- e.g. LA-001 where L indicates liquid, A indicates chemical with alphabet A, like Acetone and 001 indicates the unique serial number allocated to particular chemical.
- On receipt of the chemicals and reagents, enter the date of received and sign. Enter the expiry or valid up to date and affix the label on the individual pack and store at designated place. If bottle is covered with polythene bag (shrink wrapping) / paper, then remove the same and affix the label on bottle.
- At the time of opening the container of reagents / chemicals, enter opened on date and use before date and sign the label.
- The expiry period for solid analytical chemicals/reagents in intact condition (un-opened) is 5 years from the date of receipt or the manufacturer’s expiry date whichever is earlier. The validity for the opened bottle is 2 years from the date of opening or up to the assigned expiry date whichever is earlier.
- The expiry period for liquid chemicals/solvents in intact condition (un-opened) is 5 years from the date of receipt or the manufacturer’s expiry date whichever is earlier. The validity for the opened bottle after opening is 1 year from the date of opening or up to the assigned expiry date whichever is earlier.
- The validity for hygroscopic chemicals is six months from the date of opening or up to the assigned expiry date whichever is earlier.
- Non compatible chemicals are to be stored separately. Preferably for each category of chemicals maintain the separate storage compartment with proper labeling, to avoid the probable accident due mixing of non compatible chemicals. Label the respective area as ‘Corrosive chemicals, Oxidative chemicals, Acids, Base, Hygroscopic chemicals etc.
- List all the reagents and chemicals (commercially available). Prepare a separate list for each category chemicals as specified above and display the copy of the same near the respective storage area. Refer annexure II.
- Review the stock periodically to ensure that the adequate stock is maintained.
- Before the stock of any reagent / chemical gets exhausted, arrange for procurement of additional Stocks.
Reagent Solutions (Prepared in laboratory) :
- Maintain specification for every reagent solution giving details of quantity, preparation and storage. Reference (e.g. IP/ BP/ USP), and validity. Refer annexure III.
- Update the specification for any change as per revision of pharmacopoeia. Document the change in the change control and in the review sheet and mention edition of pharmacopoeia.
- Prepare reagent solution as per the procedure given in the individual specification and record the reagent preparation details in annexure IV. In case of indicator solution, perform the sensitivity test fortnightly from the date of preparation and record the same in the test data sheet as per Annexure XIII
- Unless otherwise specified, preserve the reagents in glass-stoppered reagent bottle of appropriate volume and label them. Preserve light sensitive solutions in amber glass- stoppered bottles and all alkali solutions in plastic containers.
- Batch Number Should be allotted to each reagent and indicator as explained below First lot of Ammonium oxalate reagent in year 2019 will be RA-01/ 19/01
- Where, RA-01: R – indicates for reagents, A-01 indicates unique serial number of the reagent starts from alphabet A.
- /19 – Indicates year 2019
- /01 – Indicates 1st batch of the year.
- Similarly for first lot of Bromophenol Blue indicator in year 2019 will be
- IB-01/19/01
- Where IB-01 – ‘I’ indicates indicator solution, B-01 indicates unique serial number of the indicator starts from alphabet ‘B’
- /19 – Indicates year 2019
- /01 – Indicates 1st batch of the year
- Check the suitability of the reagents visually before each use. If turbidity / foreign particles are observed, discard the same and prepare freshly.
- All the reagents are valid for the period of 3 months from the date of preparation unless otherwise specified and are required to be freshly prepared. In case of indicator, if sensitivity check results in failure, discard the same and prepare freshly.
- Check visually the appearance, colour, turbidity, foreign particles, fungal growth but not limited to of reagent/indicator solutions with interval of 15 days, 30 days, 45 days, 60 days, 75 days and 90 days. Maintain the visual observation record. Refer Annexure – XIV.
- If solution fails to meet the criteria of visual observation test then destroy the reagent and prepare new reagent solution. Re assign the validity period to particular solution as use freshly prepared or one month.
- If the commercially available indicator solutions are used, check the sensitivity test and assign the validity of 6 months from the date of opening.
- All the reagent solutions are to be prepared, stored and used at room temperature unless otherwise specified.
- List all the reagent solutions; prepare the separate list for indicator solutions. Refer annexure V.
Volumetric Solutions:
- Maintain volumetric solution specification for every volumetric solution indicating quantity, preparation, standardization, calculations, storage, reference (e.g. IP/ BP/ USP) and validity. Refer annexure VI.
- Update the specification for any change as per revision of pharmacopoeia. Document the change in the change control and in the review sheet and mention edition of pharmacopoeia.
- Prepare volumetric solutions as directed in the individual specification once in a month or whenever required. Readymade commercially available volumetric solutions can be used after standardization. Enter the details in annexure VII for each volumetric solution.
- The quantity of volumetric solution shall be varied as per requirement for analysis otherwise quantity shall be prepared 1000 ml.
- Unless otherwise specified, preserve in glass-stoppered bottle of appropriate volume and label them. Preserve light sensitive solutions in amber glass-stoppered bottles and all alkali solutions in plastic containers.
- Batch Number shall be allotted to each volumetric solution as explained below
- First lot of 0.1M Zinc sulphate solution prepared in year 2019 will have the No. VS- 01 / 19/ 01.
- Where VS- 01 is the unique code no. for a particular volumetric solution, /19 indicate year 2019 and /01 indicates 1st batch of the volumetric solution.
- Standardize all the volumetric solutions after preparation and whenever required, according to the procedure given in the individual specification. Record the data on individual TDS. Refer annexure VIII.
- Carry out the standardization in triplicate using volumetric standards wherever required.
- The Molarity / Normality of the volumetric solution is determined with a precision (RSD) of Not more than 0.2 %. Calculate the average of these three Molarity / Normality.
- The Normality / Molarity should be within the limit of 10 % of the theoretical value. If it is beyond 10 %, then prepare fresh solution.
- Get the report checked by the reviewer. Enter all the details in the individual preparation and standardization record.
- While using auto titrators, standardize the solution before use and record the observation in the TDS. Get it checked and use that Normality/ Molarity for the particular analysis. Enter all the details in the individual preparation and standardization record.
- Use the Normality / Molarity determined by the auto-titrator for that particular day only.
- Prepare solutions of lower Normality / Molarity accurately by making an accurate dilution of a stronger solution. If the diluted volumetric solutions are to be used for assay determination, re standardize the diluted solution other wise use the Normality / Molarity of stronger solution. Volumetric solutions prepared by dilution shall be standardized as directed in the volumetric solution specification.
- All the volumetric solutions are valid for the period of 1 month from the date of standardization unless otherwise specified.
- The restandardization date/period of volumetric solution shall be defined based on volumetric solution stability study.
- Restandardization shall be carried out if the particular volumetric solution required after its restandardization due date otherwise restandardization shall not be carried out.
- If volumetric solution is not required after its expiry then next solution to be prepared when that particular solution required for analysis.
- Validate the period of usage by determining the Molarity of each of the solutions at the end of the validity period and comparing the value with the initial molarity. This shall be done once initially for each volumetric solution. Prepare the validation protocol, summery report & conclusion. Refer annexure IX & X respectively
- Protocol number shall be given as P/19/VS-03/01
- Where,
- P –Protocol 19- for last digit for 2019 VS-03- Solution number
- 01 –Version number
- The validity period one month & Restandardization frequency 15 days shall be assign if the Molarity determined at the end of the validity period does not deviate by more than 0.5 % of the initial value.
- The validity period 15 days & Restandardization frequency 7 days shall be assign if the Molarity determined at the end of the validity period is deviate more than 0.5% of the initial value but not more than 1.0%.
- The validity period 7 days & restandardization frequency “Before use” shall be assign if Molarity determined at the end of the validity period is deviate more than 1.0% of the initial value but not more than 2.0%. If more than 2.0% observed then solution shall be prepared freshly and used within 24 hours.
- All the volumetric solutions are to be prepared, standardized, stored and used at Room temperature unless otherwise specified.
- List all the volumetric solutions. Refer annexure XI
Usage of Reagents, Chemicals and Volumetric solutions :
- While using hazardous chemicals; wear suitable personal protective equipment. Do not smell or taste chemicals. Skin contact with chemicals should be avoided.
- Refer the label of the individual chemical to identify the nature of the same like Explosive, Oxidizing, Corrosive, Highly flammable, Toxic, irritant, etc. by referring the hazard symbol, plain text warnings, Risk and safety (R & S) statement. Take appropriate precautions with respect to nature of the chemical under usage.
- Refer material safety data sheets (MSDSs) before moving, opening or usage of any chemicals. Never use a chemical/ reagent/ volumetric solution from an unlabeled container.
- During usage and withdrawal of the required quantity of chemical or reagent from the container, suitable accessory or containers to be used. e. g. Clean glass or SS spatula, glass beakers etc. which is non reactive with the material.
- For withdrawing of liquid chemicals, clean and dry pipettes are to be used.
- For dispensing of large volume of chemicals like Acetonitrile, Methanol, acids e.g. Acetic acid, Hydrochloric acid, Sulphuric acid etc. bottle top dispenser should be used.
- Following precautions to be taken during usage of chemicals stored in refrigerator. Chemicals with low boiling point e.g. Ether, Hydrogen peroxide, Ammonia etc. are to be refrigerated before use / opening. Un-cooled bottle, if opened may lead to splashing of solvents which may results in accidents. Solutions which are stored at temperature between 2°C to 8°C and freezer, before use, keep the same for not less than 30 minutes to attain ambient temperature.
- Organic solvents which are to be stored in refrigerator, use the flame proof refrigerator to avoid any probable accident.
- During usage, after opening the containers if the content found not homogeneous, do not use such chemical / reagent.
- In case of hygroscopic material, after opening the container if the material is found moist, do not use the same. Dispose the moist chemical as per respective disposition procedure.
- In case of prepared reagent / volumetric solution, before use check the solution for color, clarity and foreign particles. If change is observed, discard the solution and prepare fresh solution.
- After usage, bottle of chemical or reagent to be tightly closed and to be kept at designated place.
- To carry the large volume chemical bottles use suitable size basket (preferably SS basket) to avoid any probable accident.
Following precautions to be taken during usage of Hazardous, toxic, corrosive and flammable chemicals :
- While transferring flammable chemicals like solvents, it should be ensured that no static charge is generated. This can be ensured by pouring the chemicals slowly to avoid turbulence and as far as possible, by using metal containers. Corrosive chemicals like strong acids are to be stored in well ventilated place like fuming cupboard in a separate acid resistant trays containing sand. Any acid splashes should be washed with water and neutralize with sodium bicarbonate solution followed by washing with plenty of water.
- Any chemical operation giving off toxic or obnoxious fumes should be carried out in functioning chemical fume hood with the exhaust fan operational.
- Use poisonous chemicals with abundant caution. Poisonous chemicals should be handled / used / dispensed always under direct supervision of senior person. Usage log for use of each poisonous chemical is to be maintained quantitatively. Refer XII.
- Ensure that incompatible chemicals/ materials are stored separately e.g. Highly oxidizing chemicals such as Thionyl chloride, Hydrogen peroxide etc should not be stored together with combustible materials like papers, similarly acid and alkali chemicals should not be stored together. Refer the incompatibility chart and store the chemical accordingly.
- For reagent / chemical other than prepared reagents / volumetric solutions used in routine analysis, make the entries of the same in the individual test data sheet.
- Expired chemical, reagent, reagent solution, and volumetric solution to be disposed as per respective SOP . Labels of empty reagent / chemical bottles should be defaced before disposal empty bottles of hazardous chemicals / acids should be rinsed with water before sending for disposal.
IV: Annexure :
Annexure I : General chemical stock record
Annexure II : Index of Reagent/Chemicals
Annexure III: Reagent solution specification
Annexure IV: Record of reagent preparation
Annexure V: Index of reagent solution
Annexure VI: Volumetric solutions specification
Annexure VII: Record of preparation/ standardization of volumetric solution
Annexure VIII: Test data sheet for volumetric solution preparation/Standardization/ Restandardization.
Annexure IX: Volumetric solution validity period study protocol
Annexure X: Volumetric solution validity period study summary report & Conclusion
Annexure XI: Index of Volumetric solution
Annexure XII: Poison usage log
Annexure XIII: Test data sheet of Reagent/Indicator solution
Annexure XIV: Reagent/Indicator visual observation Record
ANNEXURE-I
GENERAL CHEMICAL STOCK REGISTER Page No.: 1 of 1
Name of Chemical/Reagent/Indicator: _________________________________________________
| Sr.
No. |
Date of Receipt | Challan No./ Date | Make | Supplier | Qty. Received
(Number X Pack size) |
Qty. Issued (Number X Pack size) | Issued On | Receiver Sign/Date | Qty. Available (Number X Pack size) |
ANNEXURE II
INDEX OF REAGENTS / CHEMICALS Page no. 1 of 1
| Sr. No. | Name of Reagent/Chemical | Batch No. | Prepared on | Valid up to |
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Prepared By: Checked By:
Date : Date :
ANNEXURE III
REAGENT SOLUTION SPECIFICATION
| Name of Solution | AMMONIUM OXALATE SOLUTION | |
| Solution No. | RA-01 | Version No. : 01 |
| Supersedes No.: | 00 | Effective Date: DD/MM/YYYY |
QUANTITY: 500 ML
PREPARATION: Dissolve 20 g of Ammonium oxalate (AR grade) in sufficient water to produce 500 ml
STORAGE: Store at room temperature
REFERENCE: IP/BP/USP (Volume No. / Specify year)
VALIDITY: 3 months
Re-standardization Period:
| Prepared By | Checked By | Approved By | |
| Name | |||
| Sign/Date | |||
| Designation | Officer /Executive QC | Executive/ Manager QC | Head QC/QA |
ANNEXURE IV
RECORD OF REAGENT PREPARATION
Item: _______________________________________________
Reagent No.: ________________________
| Sr. No. | Date of Preparation | Batch No. | Total volume prepared (ml) | Valid upto | Prepared By | Checked By/ Date |
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ANNEXURE V
INDEX OF REAGENT SOLUTIONS
| Sr. No. | Name of Reagent Solution | Solution No. | Prepared on | Valid up to |
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ANNEXURE VI
VOLUMETRIC SOLUTION SPECIFICATION
| Name of Solution | 0.002 M SODIUM THIOSULPHATE | |
| Solution No. | VS-29 | Version No. : 01 |
| Supersedes No.: | 00 | Effective Date: DD/MM/YYYY |
QUANTITY: 1000 ml, 2000 ml
PREPARATION:
For 1000 ml
- Dissolve 0.5 g of Sodium thiosulphate and 0.004 g of sodium carbonate in carbon dioxide – free water and dilute to 1000 ml with the carbon dioxide – free water.
OR
- Dilute 20 ml of 0.1 M of Sodium thiosulphate VS to a 1000 ml with carbon dioxide – free water.
For 2000 ml
- Dissolve 1.0 g of Sodium thiosulphate and 0.008g of sodium carbonate in carbon dioxide – free water and dilute to 2000 ml with the carbon dioxide – free water.
OR
- Dilute 40 ml of 0.1 M of Sodium thiosulphate VS to a 2000 ml with carbon dioxide – free water
STANDARDISATION: Dissolve 0.0167 g of Potassium bromate volumetric standard, weighed accurately, in sufficient carbon dioxide-free water to produce 1000.0 ml. To 50.0 ml of this solution, add 0.04 g of potassium iodide and 0.1 ml of 2 M Hydrochloric acid and titrate with the Sodium thiosulphate solution using starch solution, added towards the end of the titration, as indicator until the blue colour is discharged. Perform the standardization in triplicate and if the results are within precision of 0.2 %, report the mean of the three results.
Each ml of 0.002 M Sodium thiosulphate is equivalent to 0.05568 mg of KBrO3.
CALCULATION:
Weight in g of potassium bromate x 50 x 1000 x % Assay of volumetric standard
Molarity = ——————————————————————————————————-
Burette reading in ml x 1000 x 0.05568 x 100
STORAGE: Store at Room temperature
REFERENCE: IP/BP
VALIDITY: 1 month
| Prepared By | Checked By | Approved By | |
| Name | |||
| Sign/Date | |||
| Designation | Officer /Executive QC | Executive/ Manager QC | Head QC/QA |
ANNEXURE VII
REGISTER OF PREPARATION / STANDARDIZATION OF VOLUMETRIC SOLUTION
Name of Solution: ________________________________________ Volumetric Solution No.: ____________________
| Sr.
No. |
Batch No. | Prepared on | Valid Upto | Standardized on | Actual Normality / Molarity | Analyst | Checked By | Restandardization on | Restandardization Normality / Molarity | Analyst | Checked By |
ANNEXURE VIII
TEST DATA SHEET FOR VOLUMETRIC SOLUTION PREPARATION/STANDARDISATION /RESTANDARDISATION
Page No. 01 of 05
| Name of Volumetric solution: 0.02 M Sodium Thiosulphate | Solution No.: | |
| Name of Reagents/Chemicals used: | B. No. | Valid Up to |
| Date of Preparation: | Volume prepared: | |
| Valid up to | ||
Analytical Balance ID No.: ______________________ Calibration Due on:____________________
Procedure:
A] Weight of sodium thiosulphate _________ g ________ g of sodium carbonate transferred into
______ ml volumetric flask. Dissolved and diluted to volume with carbon dioxide – free water.
OR
B] _______ ml of 0.1 M sodium thiosulphate VS (B. No. ___________ ) diluted to ________ ml with carbon dioxide free water.
OR
C] Transferred the contents of _______ number of ampoules (Make : _________________,
B.No.: ____________ ) into a _______ ml volumetric flask. Rinsed the ampoules with carbon dioxide free water, added rinsings to the flask and diluted upto the mark with carbon dioxide – free water.
Prepared By: _________________________ Checked By:___________________________
| Prepared By | Checked By | Approved By | |
| Signature | |||
| Date |
Page No. 02 of 05
- STANDARDISATION OF 0.002 M SODIUM THIOSULPHATE
Analytical Balance ID No.: ________________ Calibration Due on:____________________
Primary standard used: _________________________ B. No.___________________________
Valid Upto:___________________________________
Procedure:
1] Weight of potassium bromate volumetric standard _________ g dissolved and diluted to _____________ ml with carbon dioxide – free water. To _______ ml of this solution added __________ g of potassium iodide and ________ ml of 2 M hydrochloric acid and titrated with 0.002 M sodium thiosulphate solution. Added starch solution towards the end of titration.
Volume of 0.002 M sodium thiosulphate solution required = ______________ ml
x 50 x 1000 x
Molarity factor = ————————————————— = ________________
x 1000 x 0.05568 x 100
2] Weight of potassium bromate volumetric standard _________ g dissolved and diluted to _____________ ml with carbon dioxide – free water. To _______ ml of this solution added __________ g of potassium iodide and ________ ml of 2 M hydrochloric acid and titrated with 0.002 M sodium thiosulphate solution. Added starch solution towards the end of titration.
Volume of 0.002 M sodium thiosulphate solution required = ______________ ml
x 50 x 1000 x
Molarity factor = ————————————————— = ________________
x 1000 x 0.05568 x 100
| Prepared By | Checked By | Approved By | |
| Signature | |||
| Date |
Page No. 03 of 05
3] Weight of potassium bromate volumetric standard _________ g dissolved and diluted to _____________ ml with carbon dioxide – free water. To _______ ml of this solution added __________ g of potassium iodide and ________ ml of 2 M hydrochloric acid and titrated with 0.002 M sodium thiosulphate solution. Added starch solution towards the end of titration.
Volume of 0.002 M sodium thiosulphate solution required = ______________ ml
x 50 x 1000 x
Molarity factor = ————————————————— = ________________
x 1000 x 0.05568 x 100
| Sr. No. | Molarity / Normality |
| 1 | |
| 2 | |
| 3 | |
| Average | |
| SD | |
| % RSD |
Next Standardization due on: ___________
Standardization done by:_______________________ Checked By:__________________
| Prepared By | Checked By | Approved By | |
| Signature | |||
| Date |
Page No. 04 of 05
- RESTANDARDISATION:
Analytical Balance ID No.: ______________ Calibration Due on:____________________
Primary standard used: _________________________ B. No.________________________
Valid Upto:___________________________________
Procedure:
1] Weight of potassium bromate volumetric standard _________ g dissolved and diluted to _____________ ml with carbon dioxide – free water. To _______ ml of this solution added __________ g of potassium iodide and ________ ml of 2 M hydrochloric acid and titrated with 0.002 M sodium thiosulphate solution. Added starch solution towards the end of titration.
Volume of 0.002 M sodium thiosulphate solution required = ______________ ml
x 50 x 1000 x
Molarity factor = ————————————————— = ________________
x 1000 x 0.05568 x 100
2] Weight of potassium bromate volumetric standard _________ g dissolved and diluted to _____________ ml with carbon dioxide – free water. To _______ ml of this solution added __________ g of potassium iodide and ________ ml of 2 M hydrochloric acid and titrated with 0.002 M sodium thiosulphate solution. Added starch solution towards the end of titration.
Volume of 0.002 M sodium thiosulphate solution required = ______________ ml
x 50 x 1000 x
Molarity factor = ————————————————— = ________________
x 1000 x 0.05568 x 100
| Prepared By | Checked By | Approved By | |
| Signature | |||
| Date |
Page No. 05 of 05
3] Weight of potassium bromate volumetric standard _________ g dissolved and diluted to _____________ ml with carbon dioxide – free water. To _______ ml of this solution added __________ g of potassium iodide and ________ ml of 2 M hydrochloric acid and titrated with 0.002 M sodium thiosulphate solution. Added starch solution towards the end of titration.
Volume of 0.002 M sodium thiosulphate solution required = ______________ ml
x 50 x 1000 x
Molarity factor = ————————————————— = ________________
x 1000 x 0.05568 x 100
| Sr. No. | Molarity / Normality |
| 1 | |
| 2 | |
| 3 | |
| Average | |
| SD | |
| % RSD |
Restandardization done By: ______________________ Checked By:______________
| Prepared By | Checked By | Approved By | |
| Signature | |||
| Date |
ANNEXURE IX
VOLUMETRIC SOLUTION VALIDITY PERIOD STUDY PROTOCOL
| Name of Volumetric Solution: | |
| Volumetric solution No. | |
| Protocol No. |
Page No. 1 of 2
APPROVAL
Reviewed By : ____________________________________________ Date : __________
Executive Quality control
Approved By : ____________________________________________ Date : __________
Head Quality Control
Authorized By : ___________________________________________ Date : __________
Quality Assurance
| Prepared By | Checked By | Approved By | |
| Signature | |||
| Date |
|
VOLUMETRIC SOLUTION VALIDITY PERIOD STUDY PROTOCOL
| Name of Volumetric Solution: | |
| Volumetric solution No. | |
| Protocol No. |
Page No. 2 of 2
- Purpose
- Scope:
- Reference:
- Site of the study:
- Responsibility
- Materials and Instruments:
- Procedure:
- Acceptance criteria:
- Results
- Conclusion:
| Prepared By | Checked By | Approved By | |
| Signature | |||
| Date |
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ANNEXURE X
VOLUMETRIC SOLUTION VALIDITY PERIOD STUDY SUMMARY REPORT AND CONCLUSION
| Name of Volumetric Solution: | |
| Volumetric solution No. | |
| Protocol No. |
Page No. 1 of 2
APPROVAL
Reviewed By : ____________________________________________ Date : __________
Executive Quality control
Approved By : ____________________________________________ Date : __________
Head Quality Control
Authorized By : ___________________________________________ Date : __________
Quality Assurance
| Prepared By | Checked By | Approved By | |
| Signature | |||
| Date |
|
ANNEXURE X
VOLUMETRIC SOLUTION VALIDITY PERIOD STUDY SUMMERY REPORT & CONCLUSION
| Name of Volumetric Solution: | |
| Volumetric solution No. | |
| Protocol No. |
Page No. 2 of 2
- SITE OF THE STUDY : Pharmaceuticals Area
- TEAM INVOLVED Analyst :
Reviewer :
Head Quality Control :
Quality Assurance :
III. MATERIALS AND INSTRUMENTS:
- b) Reagent / Chemicals :
- Summary:
Validity period:
The validity period is monitored to check the stability of solution. A volumetric solution was preserved over a period of 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36 days and analyzed after the specified intervals.
The Molarity of initial analysis and the Molarity of analysis after preservation up to 36 days was compared and found to be well within limit.
As the result of initial analysis and analysis after preservation upto 36 days are comparable, the Volumetric solution is stable upto 36 days. So assigning the validity period for this particular solution to 1 month (30days)
Performed By : Reviewed By :
Date : Date :
| Prepared By | Checked By | Approved By | |
| Signature | |||
| Date |
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ANNEXURE XI
QUALITY CONTROL DEPARTMENT
Page no. 1 of 1
INDEX OF VOLUMETRIC SOLUTIONS
| Sr. No. | Solution No. | Strength | Name of volumetric solution |
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| Prepared By | Checked By | Approved By | |
| Signature | |||
| Date |
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ANNEXURE XII
POISON USAGE LOG
Item: ___________ Poison No. : _________________
Manufactured by : _______________ Batch No. : _________________
Quantity received: _______________ Date of opening : _________________
Valid upto : ______________
| Consumed for :
Item Name |
A. R. No. | Weight of bottle + material
in g or ml (A) |
Weight of bottle
+ material after dispensing in g or ml (B) |
Weight of material withdrawn in g or ml C = A – B | Date and Sign Analyst | Date and Sign QC Head |
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ANNEXURE XIII
TEST DATA SHEET FOR REAGENT / INDICATOR SOLUTION
Page No. 01 of 01
| Name of solution: | Reagent/ Indicator No.: | |
| Name of Reagents/Chemicals used: | B. No. | |
| Date of Preparation: | Volume prepared: | |
| Use Before: | ||
Analytical Balance ID No.: ______________________ Calibration Due on:____________________
Procedure:
Clearity of Solution: Clear / Not Clear
=====================================================================
Sensitivity (Applicable for Indicator):
Prepared By Checked By:
Date: Date:
ANNEXURE XIV
REAGENT/INDICATOR SOLUTION VISUAL OBSERVATION RECORD
Name: ________________________________________
| Sr.
No. |
Name of Reagent /Indicator Solution | Date of preparation | Batch No. | 15 Day | 30 Day | 45 Day | 60 Day | 75 Day | 90 Day | Remark | ||||||
| Obs | Checked By Sign/ Date | Obs | Checked By Sign/ Date | Obs | Checked By Sign/ Date | Obs | Checked By Sign/ Date | Obs | Checked By Sign/ Date | Obs | Checked By Sign/ Date | |||||
