DOXPUB 09-0073-SOP

Summary:

Dscribes a procedure to determine the biotin content of a sample (free biotin concentration or moles of biotin per mole of protein, B/P). Applicable to a variety of proteins, including biotinylated murine IgG, biotinylated murine IgM, biotinylated rat IgG, biotinylated polyclonal antibodies, etc., solutions of free biotin and other uses which may be identified at a later date. Covers general preparation, sample preparation, mesurements, and calculations for analysis of biotinylated samples.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Biotin Assay Report Sheet

About This Document:

This is not a generic template, it's a 5-page procedure that was actually created and used in the Quality Control operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

Reasons to Buy:

• Use it as a starting point for your own documentation project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel