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PDA Technical Methods Bulletin 3, Glass Containers for Small Volume Parenteral Products: Factors for Selection and Test Methods for Identification (single user digital version)

PDA Technical Methods Bulletin 3, Glass Containers for Small Volume Parenteral Products: Factors for Selection and Test Methods for Identification (single user digital version)

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  • Description
  • Table of Contents

This Technical Methods Bulletin was prepared by the Task Force 17.

This bulletin is intended as a review of representative methods used by glass manufacturers to rapidly identify the various types of glass containers used by the parenteral drug industry. These methods may be used to assist in obtaining a desired level of assurance that incoming containers conform to their requirements, as a basis for an in-house testing program or for periodic rapid confirmation of the manufacturer`s certificate of glass type.

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Format: PDF (1 file - 739 KB)

Table of Contents:

1. Introduction
2. Classifications/Designations of Parenteral Glasses

  • USP Classifications
  • Manufacturer's Designation
    3. Factors for the Selection of Glass Containers
    4. Identification Test Methods
  • USP Powdered Glass Test
  • X-Ray Fluorescence Test
  • Thermal Expansion and Density Test.,/li>
    5. Collaborative Glass Identification Project
    6. Summary
    7. References
    8. Bibliography

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