Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Component Selection for Sterile Compounding

Author(s):  Dilzer Richard H

Issue:  Jul/Aug 2017 - Volume 21, Number 4
View All Articles in Issue

Abstract:  This article describes the factors to consider, as well as the process of proper component selection, for use in preparing compounded sterile preparations. Special emphasis is placed on individual chemical factors that may impact a preparation’s accuracy and potency. Values reported in a typical certificate of analysis are discussed, including methods of identifying any required adjustments to a master formulation or compounding record during the compounding of sterile preparations. Proper screening of the certificate of analysis, the Safety Data Sheet, procedural documentation, and the filing of all certificates of conformance are crucial to the operation of a sterile compounding facility.

Related Keywords: Richard H. Dilzer, RPh, FACA, FIACP, compounded sterile preparations, certificate of analysis, documentation, standard operating procedures, vendor, package integrity, good manufacturing practice, safety data sheet, United States Pharmacopeia Chapter <797>, United States Pharmacopeia Chapter <1160, USP, Compounding Compendium, potency, purity, quality control, loss on drying

Related Categories: EXCIPIENTS, SOPs, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

Printer-Friendly Version




Download in electronic PDF format for $65

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Component Selection for Sterile Compounding Dilzer Richard H Jul/Aug 2017 277-280 Buy
PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>,<797>, and <825>: Part 1 Allen Loyd V Jr Mar/Apr 2020 92 Buy
Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice Kelley Brian Mar/Apr 2021 115-124 Buy
PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>, <797>, and <825>: Part 2 Allen Loyd V Jr May/Jun 2020 180 Buy
Basics of Sterile Compounding: Intravenous Admixture Preparation, Part 12: United States Pharmacopeia Chapters Referenced in the Current United States Pharmacopeia Chapter <797> Pharmaceutical Compounding -- Sterile Preparations Allen Loyd V Jr Nov/Dec 2021 491-496 Buy
Basics of Compounding: Implementing United States Pharmacopeia Chapter <795> Pharmaceutical Compounding--Nonsterile Preparations, Part 3 Allen Loyd V Jr Nov/Dec 2011 488-496 Buy
Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 3: Risk Levels Allen Loyd V Jr, Okeke Claudia C Sep/Oct 2007 404-410 Buy
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 16: Suggested Standard Operating Procedures Okeke Claudia C, Allen Loyd V Jr Nov/Dec 2009 546-553 Buy
Update on the Proposed Revision Process for United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations Okeke Claudia C Jul/Aug 2007 302-305 Buy
Quality Control: (Material) Safety Data Sheets Allen Loyd V Jr Mar/Apr 2017 118-124 Buy
Particle Measuring Systems - USP <797> Environmental Monitoring Solutions