sop for preparation and storage of reagent solution

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2 years ago

sop for preparation and storage of reagent solution

1.0 OBJECTIVE
1.1 To describe a procedure for Preparation and storage of Reagent solution.
2.0 SCOPE
2.1 This procedure is applicable for Preparation and storage of Reagent solution to the Quality control department of Quality control Laboratories.
3.0 RESPONSIBILITY
3.1 Officer/Executive – QC
4.0 ACCOUNTABILITY

4.1 Head – QC
5.0 PROCEDURE

5.1 Ensure that the chemical used for preparation of solutions are within the expiry date.

5.2. Use AR/LR grade certified chemicals for the preparation of solutions.

5.3 Prepare the required solutions as per the respective pharmacopoeia
5.4 Fill the prepared solutions in clean Amber colour / Transparent / Plastic dried reagent bottle.
5.5 In Amber colour glass bottle – Keep all light sensitive solutions.
5.6 In transparent glass bottle – Keep all reagents other than light sensitive solutions except Sodium Hydroxide.
5.7 In Plastic Bottle – Keep Sodium Hydroxide all type of solutions (i.e. Normal, Molar etc.)

5.8 Label the bottle appropriately

Name of General Solution:

Reagent Solution ID.No.:

Date of Preparation:

Best Before Use:

Prepared By/Date:

Checked By/Date:

Format No.

5.9 Assign one month’s best before use for all the solutions except if specified in the individual solution Preparation procedure.

5.10 All the test solutions shall be stored the conditions as hold time study label of bottle / container

if not recommended store in laboratory at ambient condition.

5.11 Before using any solution, check for the best before use date and clarity of solution for

visual check with mark (✔) or (X). If found hazy or microbial growth dispose the same as per SOP

(Disposal of Expired Chemical, Reagents and solvents) and prepare fresh solution.

5.12 Record the list solution preparation as per Format No.

5.13 Reagent Solution ID. No. given as RS-XX.
Where RS = Reagent Solution and XX = Serial number (01 inward).
RELATED DOCUMENT
6.1 Nil

REFERENCE

7.1 In House

FORMATS
8.1 : List of Reagent Solution

8.2 Preparation of Test Reagent

8.3 Label of Reagent Solution
8.4 Visual Check For Reagent Solutions

ABBREVIATIONS
9.1 QC : Quality Control
9.2 QA : Quality assurance
9.3 QCA : Quality Control Analytical
9.4 Ref. No. : Reference Number
9.5 A.R. : Analytical Reagent
9.6 L.R. : Laboratory Reagent
9.7 SOP : Standard Operating Procedure

10.0 REVISION HISTORY