Standard Operating Procedure for Assay of Active Ingredient in Granules

1) Purpose

The purpose of this SOP is to outline the procedure for conducting assay testing of the active pharmaceutical ingredient (API) in granule formulations to ensure the potency and quality of the product.

2) Scope

This SOP applies to all personnel involved in the assay testing of active ingredients in granule formulations within the pharmaceutical quality control (QC) department.

3) Responsibilities

Analytical Chemist: Responsible for performing assay testing and documenting results.
Quality Assurance (QA) Department: Responsible for reviewing and approving the assay testing procedure and results.

4) Procedure

1. Sample Preparation:
   1. Prepare the sample following specified procedures, ensuring accurate measurement and representation of the batch.
   2. Handle and store samples according to appropriate conditions to maintain stability and integrity.
2. Testing Method:
   1. Utilize validated analytical methods such as high-performance liquid chromatography (HPLC) or spectrophotometry for assay determination.
   2. Calibrate equipment and ensure suitability for the intended use.
3. Analysis:
   1. Perform assay testing according to established protocols and specifications.
   2. Record observations and any deviations encountered during testing.
4. Data Analysis and Interpretation:
   1. Analyze test results and calculate the concentration of the active ingredient based on calibration standards.
   2. Evaluate results against acceptance criteria to determine compliance with specifications.
5. Reporting:
   1. Prepare an assay testing report summarizing the procedure, results, calculations, and conclusions.
   2. Submit