sop for preparation and storage of reagent solution

 

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

Revision Reason for Revision Effective Date
00 NEW SOP  

sop for preparation and storage of reagent solution

sop for Calibration and Maintenance of Laboratory Instruments and Equipment

Disposal of Residual Sample or Left Over Material

sop for for Laboratory Incident

standard operating procedure temperature monitoring

sop for drying of silica gel

sop for operation of infrared moisture balance

sop for preparation of mobile phase

sop for treated RO water

sop for Preparation and Issuance of Analysis protocol standard

sop of placebo and impurity stock solutions

sop for disposal of residual sample  

sop for handling of pharmacopoeial changes

sop for procedure for operation of ultrasonic cleaner

difference between UPLC and HPLC

sop for for Emergency Eyewash and Shower

sop for operation and calibration of total organic carbon analyzers

sop for operation of cobb tester

sop for Operation and calibration of atomic absorption spectrophotometer

sop for Operation and calibration of gas liquid chromatograph

sop for operation of humidity oven

sop for operation and calibration of serological water bath

sop for monitoring of drain trap

sop for destruction of analytical samples after testing and control samples

sop for destruction of used chemicals

Sop for Operation of suction pump

sop for Operation and calibration uv cabinet

sop for Operation and calibration of bulk density apparatus

sop for operation and calibration of shore hardness tester

sop for operation of rub proofness tester

sop for monitoring of purified water

sop for Retesting of packaging materials

sop for Retesting and resampling of raw materials

sop for Control of issuance of record of analysis green sheets

sop for Control of computer passwords

sop for sampling of packaging materials PM

 

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