This procedure describes the system of preparation, standardization and storage of reagents, chemicals and volumetric solutions.
This SOP is applicable to all reagents, chemicals and volumetric solutions in Quality Control Department at manufacturing facility of Pharmaceutical Industry.
HEALTH, SAFETY AND ENVIRONMENT :
Wear adequate protective gear such as safety goggles and acid/alkali proof gloves while handling corrosive reagents/ chemicals.
Carry out all operations involving corrosive liquids in the fume hood.
Use dispensers for dispensing corrosive liquids like strong acids or alkalis.
REAGENT SOLUTIONS (Prepared in laboratory):
Maintain reagent solution register for every reagent solution giving details of the method of preparation, storage conditions and validity.
Prepare reagents and record the details such as Reagent Name , Reagent No. , date of preparation, weights taken, total volume, prepared by, checked by and valid up to. Record the data on Reagent sheet as Annexure-VI for each reagent solutions.
Preserve the reagents and indicator solutions in glass-stoppered reagent bottles and label them for details such as the item, solution number/B.No. Prepared by, date, valid up to and storage Condition as per Annexure V.
Solution Number should be allotted to each reagent as explained below:
First lot of Arsenic standard solution prepared in year 2021 will have the solution number RA-01 and batch number RA–01/2101, where ‘RA–01’ is the unique code number for a particular reagent which is classified under alphabet ‘A’, ‘21’ is the last digit of the current year i.e., 2021 and ‘01’ indicates the number of times the solution is prepared in the year 2021. When the solution is prepared for the second time, the number ‘01’ changes to ‘02’ and so on. (i.e., the batch number for second preparation will be RA–01/2102, followed by RA–01/2103 and so on).
The next reagent in ‘A’ class (e.g. Ammonia) will have the number RA–02 and batch number RA–02/2101, when prepared for the first time in the year 2021.
Similarly, the first reagent in ‘B’ class will have the number RB–01/2101 for first batch of the year 2021.
If indicators are procuring as readymade, affix a label, and maintain a list of indicators.
If indicators are preparing at unit level, allot the number for first lot of indicator solution of Bromophenol Blue as IB–01/2101, where ‘IB – 01’ is the unique code number for a particular indicator solution classified under alphabet ‘B’, ‘21’ is the last digit of the current year i.e., 2021 and ‘01’ indicates the number of times the solution is prepared in the year 2021. The next indicator solution in ‘B’ class will have the number IB–02 and batch number IB–02/2101, when prepared for the first time in the year 2021. Similarly, the first indicator in ‘C’ class will have the number IC–01/2101 for first batch of the year 2021.
Check the reagents and indicator solutions before usage for clarity and appearance of solution.
Check the suitability of the reagents visually before each use. All the reagents and indicator solutions are valid for a period of 3 months unless otherwise specified.
Maintain volumetric solution record for every volumetric solution indicating details like method of preparation, standardization, storage, validity and calculations.
Prepare volumetric solutions once in a month or whenever required. Enter the details such as VS No., Date of preparation, Volume prepared, and date of standardization, normality / molarity factor, standardized by and checked by, remaining qty destroyed by as per Annexure III.
Preserve the solution in appropriate glass-stoppered bottles and label them with details like item name, volumetric solution No., Molarity, Prepared By, Prepared on, Valid up to and Storage condition as per Annexure II.
The molarity factor shall be mentioned in volumetric solution register. During analysis & calculation, the molarity factor for the volumetric solution shall be taken from volumetric solution register against verification of volumetric solution number as per Annexure III.
Solution number should be allotted to each volumetric solution as explained below:
First lot of 0.1 M Ammonium Thiocyanate
solution prepared in year 2021 will have the solution number VS-01 and batch number VS–01/2101, where ‘VS–01’ is the unique code number for a particular volumetric solution, ‘21’ is the last two digit of the current year i.e., 2021 and ‘01’ indicates the number of times the solution is prepared in the year 2021. When the solution is prepared for the second time, the number ‘01’ changes to ‘02’ and so on. (i.e., the batch number for second preparation will be VS–01/2102, followed by VS–01/2103 and so on).
Standardize all the volumetric solutions after preparation and whenever required. Assign Volumetric solution numbers for each solution standardized and record the data on format of volumetric solution preparation and standardization as Annexure IV.
Carry out the standardization in triplicate using valid primary standards wherever required.
The molarity of the volumetric solution is determined with a precision of 0.5 %.
Calculate the mean of these three molarities and report as the molarity on the label and molarity factor in the volumetric solution register of the particular volumetric solution. (Use autotitrator wherever possible).
If the triplicate molarity factors determined differ by more than 0.5%, then repeat the determination and take the mean of the values, which do not differ by more than 0.5 % and report as the molarity on label of molarity factor in the volumetric solution register.
If the determined normality/molarity factor is not within the limit of ±10% of the theoretical value, then strengthen or dilute the solution and restandardise.
Get the report checked by the trained chemist.
While using autotitrators for titrations standardize the solution using the auto-titrator only before use and record the weighing, calculations in the Raw Data sheet for auto titrations. Get it checked and use that molarity factor for the particular analysis.
Use the normality / molarity factor determined by the auto-titrator for that particular day only.
Prepare stronger or weaker solutions and standardize in the same general manner as described using proportionate amounts of the reagents.
Prepare solutions of lower normality’s accurately by making an exact dilution of a stronger solution. Volumetric solutions prepared by dilution should be restandardised as directed for the stronger solution.
All the volumetric solutions are valid for the period of 1 month unless otherwise specified.
GTP of volumetric solution shall be prepared as per annexure VIII.
GTP number shall be followed as below
XX : Company Name
GTP : General Test procedure
VS : Volumetric solution
01 : Version No.
Prepared the Index for volumetric solution as per annexure IX.
As per Employee Training SOP
As per SOP on SOP
Annexure I : Label for Reagent solution.
Annexure II : Label for Volumetric solution.
Annexure III : Volumetric solution register.
Annexure IV : Format for Volumetric solution preparation and Standardization.
Annexure V : Label for Indicator solution.
Annexure VI : Format for Reagent solution preparation.
Annexure VII : Reagent solution registers.
Annexure VIII : GTP for Volumetric solution.
Annexure IX : Index for Volumetric solution.