[1] DRUG MONOGRAPH AND USP

PHARMACOPEIA

• An official compilation of monographs

• A book of public standards for medicines, dosage forms, drug substances, excipients, biologicals, compounded preparations, medical devices, dietary supplements, and other therapeutics

PHARMACOPEIA

contents

• Drug monographs

• Quality control standards

• Analytical methods

• Dosage forms

• Packaging and labeling requirements

• Storage conditions

USP: United States Pharmacopeia

Uniform set of guidelines for best understood medicinal substances and preparations

USP: United States Pharmacopeia first edition

1820

NF: National Formulary

Standards for excipients, botanicals and other similar products

NF: National Formulary first edition

1888

USP-NF ONLINE
latest version

• USP-NF 2025 Issue 2

• February 03, 2025

other pharmacopeias

• the homeopathic pharmacopeia of the united states

• japanese pharmacopeia

• philippine national formulary

• british pharmacopeia

OFFICIAL TEXT

• Published in the USP-NF online

• Routine revisions are published online and become official usually six months after publication

OFFICIAL TEXT

discontinued

Print version and USB flash drive version

OFFICIAL ARTICLES

• Article recognized by USP-NF

• Monograph of the article is published in the compendium

• Involves official substances and official products

Acceptance Criteria

Allow for analytical error, for unavoidable variations in manufacturing and compounding, and for deterioration to an extent considered acceptable under practical conditions

Acceptance Criteria

• provides __

range of acceptance wherein an article will still be considered as in compliance with standards

An official product shall be formulated with the intent to provide __

100% of the quantity of each ingredient declared on the label

General Chapters

• Descriptions of tests and procedures for application

• Descriptions and specifications of conditions and practices for pharmaceutical compounding

• General information for the interpretation of the requirements

• Descriptions of general pharmaceutical storage, dispensing, and packaging practices

• General guidance to manufacturers of official substances or products

General Chapters

• Below 1000

– applicable to an article

General Chapters

• 1000 to 1999

for informational purposes only

General Chapters

• Above 2000

applicable only for dietary ingredients and dietary supplements

MONOGRAPH

• Written document or standard that describes an item

• Bears the article’s name, definition, specifications and other requirements related to packaging, storage and labeling

MONOGRAPH

• specifications

tests, procedures and acceptance criteria

MONOGRAPH helps

ensure strength, quality and purity of article

MONOGRAPH COMPONENTS

• Molecular Formula

• Added Substances

• Description and Solubility

• Identification

• Assay

• Impurities and Foreign Substances

• Performance Tests

• USP Reference Standards

Molecular Formula

• Define the required strength of a compendial article

• To designate chemical entity or entities, as given in the complete chemical name of the article, having absolute purity

Added Substances

• Unsuitable for inclusion in an official article

• Not all monographs contain this component

Added Substances

• Must not be listed if it violates one of these conditions:

• If their presence impairs the bioavailability, therapeutic efficacy or safety of the official article

• If they interfere with the assays and tests prescribed for determining compliance with compendial standards

Added Substances

• In Official Substances:

• Must not exceed the minimum quantity required for providing their intended effect

• Label should indicate names and amounts of added substances

Added Substances

• In Official Products:

• Suitable substances and excipients may be added to enhance stability, usefulness, or elegance, or to facilitate its preparation

• In compounded preparations

• In dietary supplements

Identification

• Aid in verifying identity of articles as they purported to be

• Establish whether the sample is the article named in USP-NF

• May consist of one or more procedures

• All requirements must be met to satisfy the requirements of the tests

Assay

Official test in the event of a question or dispute regarding the preparation’s conformance to official standards

Impurities and Foreign Substances

Provided to limit substances to amount unobjectionable under conditions in which article is customarily employed

Other Impurities in USP and NF Articles

• No impurity shall be detected or present after

chromatography

Other Impurities in USP and NF Articles

• Amount and identity of the impurity shall be stated in the

labeling or certificate of analysis of the official substance

Other Impurities in USP and NF Articles

• The presence of any unlabeled other impurity in an official substance is unacceptable if

0.1% or greater from the standards.

Other Impurities in USP and NF Articles

• sum of all other imprities combined __

Must not exceed 2.0%

Other Impurities in USP and NF Articles

• Any known toxic substance __

shall not be listed

Performance Tests

For drug products or finished products where content uniformity determinations have been made using the same analytical methodology specified in the Assay

USP Reference Standards

• Authentic specimens that have been approved as suitable for use as comparison standards in USP/NF tests and assays

• Only results obtained using specified USP RS are conclusive

• To be used in accordance with the instructions on the label

TEST RESULTS

• rounding rules

• Calculated values should be rounded off to the number of decimal places that is in agreement with the limit expression

• Round off only in the final calculations

• Intermediate calculations may be rounded off for reporting purposes, but original value must be used for any additional required calculations

• Acceptance criteria are fixed numbers and are not rounded.

RS

USP Reference Standard

CS

Colorimetric Solution

TS

Test Solution

VS

Volumetric Solution

“ABOUT”

A quantity within 10%

ALCOHOL CONTENT

Percentage by volume of C2H5OH at 15.56

“Alcohol”

ethyl alcohol or ethanol

”Dehydrated alcohol”

absolute alcohol or anhydrous alcohol

BLANK DETERMINATIONS

Determination using same quantities of same reagents treated in the same manner as solution containing test substance but without the substance itself

DESICCATOR

Use of a tightly closed container of a suitable size and design that maintains atmosphere of low moisture content by means of suitable desiccant

NEGLIGIBLE

Quantity not exceeding 0.50 mg

ODOR

Evaluation of a suitable quantity of freshly opened material after exposure to the air for 15 minutes

PRESSURE

Determined by use of suitable manometer or barometer

SPECIFIC GRAVITY

Weight of a substance in air at 25o divided by the weight of an equal volume of water at the same temperature

TEMPERATURE

• Expressed in degrees Celsius

• All measurements at 25^o, unless indicated

WATER

As an Ingredient in an Official Product

must meet requirements of appropriate water monograph

WATER

In the Manufacture of Official Substances

must meet requirements for drinking water

WATER

In a Compendial Procedure

must meet requirements for Purified Water USP

WEIGHTS AND MEASURES

• International System of Units (SI)

• “weight” = “mass”

• degrees ( ○ ) without any qualifying unit of measure = degrees Celsius

Length

– m, cm, mm, μm/mcm, nm, Å

Mass

– kg, g, mg, μg/mcg, ng, pg, Da, kDa

Time

– s, min, h

Volume

L, dL, mL, μL/mcL

Temperature

℃

Amount of substance

mol, mmol, μmol, Eq, mEq, Osmol, mOsmol

Pressure

– Pa, kPa, psi, mm Hg

IMPORTANCE

• To give public standards for comparison of quality

• To give assurance of uniformity, consistency and quality of ingredients and products

• To control the quality of pharmaceutical, dietary supplements and food ingredient products