Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

Quality Control: Analytical Methods. Certificates of Analysis, Part 1

Author(s):  Allen Loyd V Jr

Issue:  Nov/Dec 2012 - Volume 16, Number 6
View All Articles in Issue

Page(s):  486-488

Quality Control: Analytical Methods. Certificates of Analysis, Part 1 Page 1
Quality Control: Analytical Methods. Certificates of Analysis, Part 1 Page 2
Quality Control: Analytical Methods. Certificates of Analysis, Part 1 Page 3

Download in electronic PDF format for $75

Abstract:  The question of what tests should be evaluated for ingredient quality and what tests are most important in evaluating Certificates of Analysis (CofA) often arise among compounding pharmacists. The purpose of this article is to present the various tests that are commonly used for assessing ingredient quality and standards. These tests are based on the U.S. Pharmacopeia 35–National Formulary 30 (USP– NF). This is the first of a two-part series; Part 2 will look at specific tests and their interpretation.

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, Certificate of Analysis, United States Pharmacopeia, quality assurance, monograph specifications

Related Categories: LEGAL, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Quality Control: Analytical Methods: Why Do I Need a Certificate of Analysis?
Zolner William J
May/Jun 2012
Pg. 226-229

Quality-Control Analytical Methods: Specific-Gravity Determinations of Liquids and Semisolids
Allen Loyd V Jr
Nov/Dec 2003
Pg. 477-480

Quality Control: Analytical Methods. Certificates of Analysis, Part 1
Allen Loyd V Jr
Nov/Dec 2012
Pg. 486-488

Quality-Control Analytical Methods: Selecting an Analytical Method
Allen Loyd V Jr
Jan/Feb 2004
Pg. 61-64

Basics of Compounding: Implementing United States Pharmacopeia Chapter <1163> Quality Assurance in Pharmaceutical Compounding, Part 1
Allen Loyd V Jr
Mar/Apr 2012
Pg. 146-150

Quality Control Analytical Methods: Method Validation
Klang Mark G
, Williams LaVonn A
Sep/Oct 2016
Pg. 381-386

Quality-Control Analytical Methods: Glossary of Quality Control/Quality Assurance Terms in Pharmaceutical Compounding
Kupiec Thomas C
, Okeke Claudia, Allen Loyd V Jr, Denison Clay
Jul/Aug 2005
Pg. 300-302

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
Pg. 115-124

Quality-Control Analytical Methods: Gas Chromatography
Kupiec Thomas C
Jul/Aug 2004
Pg. 305-309

Quality-Control Analytical Methods: High-Performance Liquid Chromatography
Kupiec Thomas C
May/Jun 2004
Pg. 223-227

Quality-Control Analytical Methods: A Discussion of United States Pharmacopeia Chapter <71> Sterility Tests
Kupiec Thomas C
Sep/Oct 2007
Pg. 400-403

Rapid-Dissolve Technology: An Interview With Loyd V. Allen, Jr., PhD, RPh
Allen Loyd V Jr
Nov/Dec 2003
Pg. 449-450

Quality Assurance and Quality Control, Part 2
Akers Michael J
May/Jun 2015
Pg. 215-221

Quality Control Analytical Methods: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 1
Vu Nicole
, Lou Jessica R, Kupiec Thomas
May/Jun 2014
Pg. 213-221

Applying Quality of Design Concepts to Pharmacy Compounding
Timko Robert J
Nov/Dec 2015
Pg. 453-463

Quality-Control Analytical Methods: Osmolality and Osmometry
Allen Loyd V Jr
Mar/Apr 2004
Pg. 143-145

Quality Control Analytical Methods: Common Concerns about Out-of-Specification Results
Lanier Lance
, Kemp Jesse
Jan/Feb 2006
Pg. 41-42

Quality Assurance and Quality Control, Part 1
Akers Michael J
Mar/Apr 2015
Pg. 121-124

Quality Control Analytical Methods: A Guide to Quality Control Testing for the Compounding Pharmacist
Zolner William J
Jul/Aug 2006
Pg. 281-284

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>,<797>, and <825>: Part 1
Allen Loyd V Jr
Mar/Apr 2020
Pg. 92

Return to Top