United State Pharmacopeia

UNITED STATES PHARMACOPEIA
Presented by
2167,2168,2169,2178,
2188,2189
CONTENTS
Pharmacopeia
United State Pharmacopeia
History
Volumes of USP
Importance of USP
Landmark Achievements by USP
Monograph
PHARMACOPEIA
An official publication containing a list of
drugs with their effects and directions

for their use.
It can be defined as;

Abookpublishedusuallyunderthe
jurisdictionofthegovernment and
containing
a list of drugs,
their formulas,
methods for makingmedicinal
preparations,
requirementsandtestsfortheir
strengthandpurity,
and otherrelatedinformation
UNITED STATES
PHARMACOPEIA
scientific nonprofit organization
sets standards for the identity,
strength, quality, and purity of

medicines, food ingredients, and
dietary supplements manufactured,
distributed and consumed worldwide.
USPs drug standards are enforceable in
the United States by the Food and Drug

Administration, and these standards are
used in more than 140 countries.
HISTORY
1820
founded in Washington, DC..

1830
Committee of Revision created (seven

members).
First revision of the USP published;
revisions continue at 10-year intervals.
1848
official compendium.
1850
Colleges of pharmacy participated in

revision.
1888
NF published by the American

Pharmacists Association.
Conti
1900
not-for-profit corporation.
1906
FDA passed USP and NF standards

1932
Reference Standards program

succeeded
1938
FDA approves drugs for safety before

marketing.
1942
USP revision cycle changed; USP

published every five years.
Conti
1963
First USAN cumulative list published.

1971
USP moves to Rockville, MD, USA.

1975
USP acquires National Formulary and

Drug Standards Laboratory from APhA.
1977
USP and NF scope redefined

1980
USP Dispensing Information (USP

DI) published.
Conti
1992
long-term collaboration with USAID.

1993
Federal Omnibus Budget Reconciliation

Acts (OBRA '90 and '93) rename USP DI.
1998
USP licensed USP DI and associated

products
2001
USP launches the Dietary Supplement

Verification Program.
2002
USPNF published annually
Conti
2004
first joint symposium in China.

2009
publication of USP Dietary Supplements

Compendium.
2011
USP/PQM registers in Ethiopia as a nongovernmental organization.
2012
USPNF translated into Chinese.

2013
new logo and tagline to celebrate and

emphasize the global scope of our work
USP creates the Herbal Medicines
Compendium.
2014
USPChina site expands to a 95,000 sq. ft.

facility with state-of-the-art laboratories.
Volumes of USP
Volume I:
Drug Information for the

Health Care Professional
Volume II:
Volume III:
Advice for the Patient.
Approved Drug Products

and Legal Requirements
USP Volumes I and II are available
through
MICROMEDEX Healthcare Series, in
printed books, or
Desktop Series CD-ROM.
USP DI Volume III is available in a
printed book only.
Volume 1
Drug Information for the Health
Care Professional.
o brand names
o Categorization
o Indications
o chemistry (chemical names, molecular
formulas, molecular weights, physical
characteristics, solubility)
opharmacology (mechanisms of
action and effects, absorption,

protein binding, elimination)
o precautions in use (including
drug interactions)
o contraindications,
omonitoring side and adverse
Volume 2
Advice For The Patient
o Important drug facts .
o Includes a Glossary of Medical Terms
and a list of Poison Control Centers

o It is an Invaluable Resource for Patient
Education
o Printed in large type and written in
patient-friendly language.
Conti
o Simplified drug monographs provide
direct, reassuring guidance on:

Proper drug use
Precautions
Side effects
Special considerations such as age,
allergies, pregnancy, breastfeeding
And more
VOLUME 3
Approved drug products and legal
requirements
o Quickly find information on which generic
drugs can be safely substituted for brand
name drugs
o important compounding information,
o drugs that have been discontinued,
o orphan drugs,
o purity and storage standards,
o as well as a manufacturer listing with their
approved drugs.
This valuable reference includes the
complete contents of the FDA's Orange

Book: Approved Drug Products with
Therapeutic Equivalence Evaluations.
It also features regarding quality,
packaging, storing and labeling
requirements, and color pill charts which
can help quickly identify pills and
capsules.
Importance of USP
USP along with FDA have the same
goals to ensure the quality of

products in the U.S. market place so
that a physician and a patient can rely
on them to treat a given indication.
The USP is primarily concerned with the
dosage form.
The FDA, in addition to dosage forms, is
also concerned about the drug

development process--how it is
manufactured, the purity of the
conditions under which it is
manufactured, and the protection of
the human subjects during the drug
testing phase.
Conti
The USP is in responsible for drug
chemistry, purity, strength,

formulation and the kinds of tests
that are done to ensure a drug is a
quality product in the U.S. marketplace.
It sets the U.S. standard, and since the
U.S. is ahead of the rest of the world, its
quality standards become guidelines for
many other countries as well.
Physicians originally set up the USP standards
in 1820.
They were primarily published and revised by
physicians every ten years from that period
until about the 1880s.
That is when it really became a pharmacy
publication with pharmacists, chemists, and
physicians involved in the revision process.
Landmark
Achievements
The greatest achievement is
the reliability of products in the U.S.
marketplace.
Monographs
Monograph of ACETIC ACID
Acetic acid
Acetic acid is a solution containing not

less than 36.0% and not more than
37.0% by weight of C2H4O2
Packaging and storage:
Preserve in tight containers
Identification:
It responds to the tests for acetate.

Non volatile residue:
Evaporate 20ml in a tared porcelain

dish on a steam bath and dry it 105C
for 1 hr: the weight of the residue does
not exceed 1.0 mg (0.005 %).
Conti
Chloride:
Add five drops of silver nitrate TS to

10 ml of a solution (1 in 10): no
opalescence is produced.
Sulfate:
Add 5 drops of barium chloride TS to
10ml of a solution (1 in 10): no turbidity
is produced.
Heavy metal:
To the residue obtained in the test for

non volatile residue add 8ml of 0.1 N HCl
warm gently until solution is complete,
dilute with water to 100 ml, and use
10ml of the solution: the limit is 0.001%.
Readily oxidized able substances:
Dilute 4.0ml in a glass-stop- pered vessel

with 20ml of water and add 0.30ml of 0.10N
potassium permanganate: the pink color is not
changed to brown at once, and the liquid does
not become entirely brown or free from pink
tint in less than 30 seconds.
Conti
Organic volatile impurities:
Meets the requirements.
Assay:
Place about 6ml of acetic acid in a
tared , glass-stop-pered flask ,and
weigh accurately .Add 40ml of water,
then add phenolphthalein TS ,and titrate
with 1N sodium hydroxide VS. Each ml
of 1N sodium hydroxide is equivalent to
60.05mg of C2H4O2.
Difference of BP & USP

BRITISH
PHARMACOPOEIA
The BP
contributes
significantly to
the overall control
of the quality of
medicinal
products.
UNITED STATES
PHARMACOPOEIA
The USP is primarily
concerned with the

dosage form, drug
development
process ,purity of
the conditions ,the
protection of the
human subjects
providing an
authoritative
statement of the
quality of that
product
collection of
quality standards
forUKmedicinals
ubstances
contains a list of
drugs, their
formulas, methods
for
makingmedicinal
preparations,
requirementsand
testsfortheir
strengthandpurity,
and
otherrelatedinform
ation.
References
USP30-NF25
Dr.
Jerome Skelly, Past Presidentat American

Association of Pharmaceutical Sciences (AAPS).

United State Pharmacopeia

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UNITED STATES PHARMACOPEIA

An official publication containing a list of

drugs with their effects and directions

It can be defined as;

sets standards for the identity,

strength, quality, and purity of

USPs drug standards are enforceable in

the United States by the Food and Drug

founded in Washington, DC..

Committee of Revision created (seven

Colleges of pharmacy participated in

NF published by the American

FDA passed USP and NF standards

Reference Standards program

FDA approves drugs for safety before

USP revision cycle changed; USP

First USAN cumulative list published.

USP moves to Rockville, MD, USA.

USP acquires National Formulary and

USP and NF scope redefined

USP Dispensing Information (USP

long-term collaboration with USAID.

Federal Omnibus Budget Reconciliation

USP licensed USP DI and associated

USP launches the Dietary Supplement

USPNF published annually

first joint symposium in China.

publication of USP Dietary Supplements

USP/PQM registers in Ethiopia as a nongovernmental organization.

USPNF translated into Chinese.

new logo and tagline to celebrate and

USPChina site expands to a 95,000 sq. ft.

Drug Information for the

Advice for the Patient.

Approved Drug Products

USP Volumes I and II are available

printed book only.

action and effects, absorption,

and a list of Poison Control Centers

direct, reassuring guidance on:

This valuable reference includes the

complete contents of the FDA's Orange

goals to ensure the quality of

The USP is primarily concerned with the

also concerned about the drug

chemistry, purity, strength,

Physicians originally set up the USP standards

Acetic acid is a solution containing not

It responds to the tests for acetate.

Evaporate 20ml in a tared porcelain

Add five drops of silver nitrate TS to

To the residue obtained in the test for

Readily oxidized able substances:

Dilute 4.0ml in a glass-stop- pered vessel

Difference of BP & USP

concerned with the

Jerome Skelly, Past Presidentat American

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