Accessed from 116.50.30.

2 by sans8 on Thu Nov 21 00:18:03 EST 2013

5820 Annotated List

NF 32
ANNOTATED LIST

General Notices, Monographs, General Chapters, Reagents, and Tables

Affected by Changes Appearing in NF 32
Page citations refer to the pages of NF 32. NoteIn the list below, if a section is new or if a subsection is added to or deleted
from an existing section, it is labeled as such in parentheses after the section or subsection name. Items on this list that appear
without the designation new, added, or deleted are items in which changes have been made to existing official text.

Excipients
Antifoaming Agent
Lauric Acid, 6039
Emulsifying Agent
Lauric Acid, 6039
Lubricant
Lauric Acid, 6039

NF Monographs

Monographs (NF 32)

Behenoyl Polyoxylglycerides, 5860
IMPURITIES
Limit of Free Ethylene Oxide and Dioxane
Tribasic Calcium Phosphate, 5883
IDENTIFICATION
Test A
High Fructose Corn Syrup, 5945
DEFINITION
IDENTIFICATION
Test B (added)
ASSAY
Procedure
IMPURITIES
Limit of Lead
SPECIFIC TESTS
Total Solids
ADDITIONAL REQUIREMENTS
Labeling
Lauric Acid (new), 6039
Lauroyl Polyoxylglycerides, 6040
IMPURITIES
Limit of Free Ethylene Oxide and Dioxane
Linoleoyl Polyoxylglycerides, 6043
IMPURITIES
Limit of Free Ethylene Oxide and Dioxane
Oleoyl Polyoxylglycerides, 6087
IMPURITIES
Limit of Free Ethylene Oxide and Dioxane
Sorbitan Sesquioleate, 6192
IDENTIFICATION
Fatty Acid Composition of Constituting Oleic
Acid, Test A and Identification of Constituting
Polyols by Thin-Layer Chromatography, Test B
SPECIFIC TESTS
Fats and Fixed Oils, Fatty Acid Composition
(added); Fats and Fixed Oils, Iodine Value
(deleted); Fats and Fixed Oils, Peroxide Value
(added)
ADDITIONAL REQUIREMENTS
USP Reference Standards
Corn Starch, 6201
INTRODUCTION
IDENTIFICATION
Test A
SPECIFIC TESTS
Microbial Enumeration Tests and Tests for
Specified Microorganisms

Purified Stearic Acid, 6227

DEFINITION
IDENTIFICATION
Test A (added), Test B (added), and Test C
(added)
ASSAY
Procedure
SPECIFIC TESTS
Congealing Temperature (deleted); Fats and
Fixed Oils, Acid Value (deleted); Fats and
Fixed Oils, Iodine Value; Mineral Acid (deleted); Neutral Fat or Paraffin (deleted); Acid
Value (added); Freezing Point (added); Color
of Solution (added); Acidity (added)
Stearoyl Polyoxylglycerides, 6229
IMPURITIES
Limit of Free Ethylene Oxide and Dioxane
Compressible Sugar, 6236
DEFINITION
IDENTIFICATION
Test A and Infrared Absorption, Test B
(added)
ASSAY
Procedure (deleted) and Content of Sucrose
(added)
IMPURITIES
Chloride and Sulfate, Chloride; Limit of Calcium; and Limit of Dextrose (Glucose), Fructose, Maltose, and Lactose
SPECIFIC TESTS
Specific Rotation (added) and Microbial
Enumeration Tests and Tests for Specified
Microorganisms
ADDITIONAL REQUIREMENTS
Labeling (added) and USP Reference Standards (added)
Confectioners Sugar, 6238
IDENTIFICATION
Test A and Test B (added)
ASSAY
Content of Sucrose (added)
SPECIFIC TESTS
Microbial Enumeration Tests and Tests for
Specified Microorganisms
ADDITIONAL REQUIREMENTS
USP Reference Standards (added)
Sugar Spheres, 6239
IDENTIFICATION
Test B (added)
ASSAY
Optical Rotation, Specific Rotation (deleted)
and Content of Sucrose (added)
SPECIFIC TESTS
Optical Rotation, Specific Rotation (added)
ADDITIONAL REQUIREMENTS
Labeling and USP Reference Standards
(added)

Official from May 1, 2014

Copyright (c) 2013 The United States Pharmacopeial Convention. All rights reserved.

Accessed from 116.50.30.2 by sans8 on Thu Nov 21 00:18:03 EST 2013

NF 32

Excipients 5821

Excipients
USP and NF Excipients, Listed by Functional
Category
In the following reference table, the grouping of excipients by functional category is intended to summarize commonly identified purposes that these excipients serve in
drug product formulations. The association of a functional
category with a particular dosage form in this table is not
absolute and does not limit the use of an excipient to a
single type of dosage form or delivery system.
Adhesive
Dosage Form: Transdermals and Patches
Dimethicone
Polyisobutylene
Air Displacement
Carbon Dioxide
Nitrogen
Alcohol Denaturant
Denatonium Benzoate
Methyl Isobutyl Ketone
Sucrose Octaacetate
Change to read:

Official from May 1, 2014

Copyright (c) 2013 The United States Pharmacopeial Convention. All rights reserved.

NF Monographs

Antifoaming Agent
Dimethicone
Lauric Acid
NF32
Myristic Acid
Palmitic Acid
Simethicone
Antimicrobial Preservative
Dosage Form: Oral Liquids
Alcohol
Benzalkonium Chloride
Benzalkonium Chloride Solution
Benzethonium Chloride
Benzoic Acid
Benzyl Alcohol
Boric Acid
Butylparaben
Calcium Acetate
Calcium Chloride
Calcium Lactate
Calcium Propionate
Cetrimonium Bromide
Cetylpyridinium Chloride
Chlorobutanol
Chlorocresol
Chloroxylenol
Cresol
Dehydroacetic Acid
Erythorbic Acid
Ethylparaben
Glycerin
Imidurea
Methylparaben

Methylparaben Sodium
Monothioglycerol
Pentetic Acid
Phenol
Phenoxyethanol
Phenylethyl Alcohol
Phenylmercuric Acetate
Phenylmercuric Nitrate
Potassium Benzoate
Potassium Metabisulfite
Potassium Sorbate
Propionic Acid
Propylene Glycol
Propylparaben
Propylparaben Sodium
Sodium Acetate
Sodium Benzoate
Sodium Borate
Sodium Dehydroacetate
Sodium Lactate Solution
Sodium Metabisulfite
Sodium Propionate
Sodium Sulfite
Sorbic Acid
Sulfur Dioxide
Thimerosal
Thymol
Zinc Oxide
Dosage Form: Ophthalmic Preparations
Benzalkonium Chloride
Benzyl Alcohol
Chlorobutanol
Propylparaben
Sorbic Acid
Antioxidant
Dosage Form: Oral Liquids
Ascorbic Acid
Ascorbyl Palmitate
Butylated Hydroxyanisole
Butylated Hydroxytoluene
Citric Acid Monohydrate
Erythorbic Acid
Fumaric Acid
Hypophosphorous Acid
Lactobionic Acid
Malic Acid
Methionine
Monothioglycerol
Potassium Metabisulfite
Propionic Acid
Propyl Gallate
Racemethionine
Sodium Ascorbate
Sodium Bisulfite