SOP FOR PREPARATION AND STANDARDIZATION OF VOLUMETRIC SOLUTION

1. OBJECTIVE:

   

1. To lay down the preparation and standardization of volumetric solutions.

2. SCOPE: 

1. This procedure is applicable for the Preparation and Standardization of Volumetric Solution in the Quality Control Laboratory .

3. RESPONSIBILITY:

1. Quality Control Officer / Executive is responsible to follow procedure as per the procedure mentioned in this SOP. 

2. QC Head is responsible for implementation and compliance of the procedure as per this SOP.

4. ABBREVIATIONS

1. SOP    :    Standard Operating Procedure

2. QC    :    Quality Control

3. AR Grade    :    Analytical Reagent Grade

4. RSD    :    Relative Standard Deviation

5. PROCEDURE: 

1. Preparation of Volumetric Solution:

1. Prepare the volumetric solution as per respective specification.

2. Record the details of preparation of volumetric solution as per Preparation and Standardization of Volumetric Solution Record (Annexure I).

2. Labeling

1. Transfer the volumetric solution from volumetric flask to clean and dry stoppered bottle.

2. Put a label with all detail as per Label for Volumetric Solution (Annexure II).

3. Storage of Volumetric Solution

1. Store all the volumetric solutions in cleaned dry glass bottles. Store light sensitive solutions in amber colour glass bottles.

2. Volumetric solution shall not be preserved for more than one month. 

3. If during usage found any change in physical properties of the solution observed, then discard the same.

4. Store all volumetric solution at room temperature or as per required.

4. Standardization

1. Standardize the volumetric solution as per respective GTP’s.

2. Use primary standard or AR. grade reagent for standardization.

3. Keep separate AR grade reagent / primary standard for standardization purpose.

4. The solution shall be standardized in triplicate. 

5. The RSD of three determinations should be NMT 0.2%. 

6. Discard the remaining quantity of volumetric solution in the burette used for the standardization.

7. Solutions shall be re standardized as per defined frequency in the respective GTP.

5. Discard the volumetric solution after expiry.