Introduction

Mineral assays play a critical role in analyzing samples to determine mineral presence, concentration, and composition. For Nexarion Biopharmaceutical, understanding mineral content is essential for product development and quality control.

Purpose of Mineral Assay

1. Quality Control:
   • Ensures raw materials and final products meet required specifications and standards.
2. Research and Development:
   • Helps formulate and optimize biopharmaceutical products by understanding mineral composition.
3. Regulatory Compliance:
   • Assists in adhering to regulatory requirements by providing detailed mineral content reports.

Key Techniques

1. Atomic Absorption Spectroscopy (AAS):
   • Measures mineral concentration by detecting light absorbed by atoms in the sample.
2. Inductively Coupled Plasma Mass Spectrometry (ICP-MS):
   • Highly sensitive technique detecting trace mineral levels through ionization and mass-to-charge ratio measurement.
3. X-Ray Fluorescence (XRF):
   • Non-destructive method determining elemental composition via emitted fluorescent X-rays.

Steps in Mineral Assay

1. Sample Preparation:
   • Involves grinding, homogenizing, and sometimes digesting the sample for uniformity and accurate results.
2. Calibration:
   • Uses standard solutions to calibrate instruments for precise measurements.
3. Analysis:
   • Runs prepared samples through the chosen analytical technique.
4. Data Interpretation:
   • Analyzes results to determine mineral content and composition.
5. Reporting:
   • Documents findings in a detailed report for further action and reference.

Applications in Biopharmaceuticals

1. Formulation Development:
   • Understands mineral interactions with active pharmaceutical ingredients (APIs) to enhance drug efficacy and stability.
2. Nutritional Supplements:
   • Ensures correct dosage of essential minerals in dietary supplements.
3. Contaminant Detection:
   • Identifies and quantifies potential contaminants for product safety and purity.