SOP for procurement of primary standard

1. OBJECTIVE:

To lay down a procedure for procurement for primary standard.

• SCOPE:

This procedure is applicable for procedure for procurement for primary standard.

• RESPONSIBILITY:

QC Officer/ QC Executive

• ACCOUNTABILITY:

QC Manager.

• PROCEDURE:
  • Prepared and procurement of primary standard as per Indian Pharmacopoeia.
  • List of Primary standard in log book.
  • Method of Preparation of Primary Standard

Primary standard prepared by following method.

• Arsenic Trioxide: Sublime arsenic trioxide in an appropriate apparatus and store over silica gel.
  • Benzoic Acid: Sublime benzoic Acid in an appropriate apparatus and store in a tightly- closed container.
  • Potassium Bromate: Recrystallise potassium bromate from boiling water. Collect the crystals and dry to constant weight at 180°. Store in a tightly-closed container.
  • Potassium Dichromate: Heat potassium dichromate to 140° to 150° in an oven, cool in a desiccator and powder in a glass mortar.
  • Potassium Hydrogen Phthalate: Recrystallise potassium hydrogen phthalate from boiling water, collect the crystals at a temperature above 35° and dry to constant weight at 110⁰. Store in a tightly-closed container.
  • Potassium Iodate: Recrystallise potassium iodate from boiling water. Collect the crystals and dry to constant weight at 120⁰. Store in tightly-closed container.
  • Sodium Carbonate, Anhydrous: Filter at room temperature a saturated solution of sodium carbonate. Introduce slowly into the filtrate a stream of carbon dioxide, with constant cooling and stirring. After about 2 hours, collect the precipitate on a sintered glass filter. Wash the filter with ice-cold water saturated with carbon dioxide. After drying at 100° today, heat to constant weight at 270° to 300°, stirring from time to time. Store in a tightly-closed container.
  • Sodium Chloride: To 1 volume of a saturated solution of sodium chloride add 2 volumes of hydrochloric acid. Collect the crystals formed and wash with hydrochloric acid. Remove the hydrochloric acid by heating on a water-bath and dry the crystals to constant weight at 300°. Store protected from moisture.
  • Sulphanilic Acid: Recrystallise sulphanilic acid from boiling water. Filter and dry to constant weight at 100° to 105°.
  • Zinc, Granulated: Wash granulated zinc with dilute hydrochloric acid, followed by water, ethanol (95 per cent) and finally acetone. Dry at 100⁰ for 5 minutes and cool in a disiccator over silica gel.
• TRAINING:

Trainer   : Manager – Quality Control

Trainees : Staff of the QC departments

• DISTRIBUTION:

Master Copy                  :           QA Department

Controlled Copy            :           QC Department

Display Copy                 :           QC Department

• ATTACHMENTS:

Sr. No.	Title	Annexure No.
01.	NA	NA

• REFERENCES:

In-House

1. ABBREVIATIONS:

Abbreviations	Extended Form
SOP	Standard Operating Procedure
NA	Not Applicable
QC	Quality Control
Sr. No.	Serial Number
QA	Quality Assurance
DEPT.	Department

1. REVISION HISTORY OF CHANGE:

Sr. No.	Date	Revision Details	Revision No.
01	17/01/2020	NEW SOP	00