United States Pharmacopeia USP-NF Presentationpdf

this has knowledge about the USP-NF
about details of monographs.it consist of a specific banaba leaf monograph

1. Amity Institute of Pharmacy
UNITED STATES PHARMACOPEIA .
Monographs
PRESENTED BY:
HARSH SRIVASTAVA
(M.PHARMA(ANALYSIS).
UNDER THE GUIDANCE OF
DR.RAMANPREET WALIA
(PROFESSOR)
AMITY INSTITUTE OF PHARMACY -NOIDA(UP).

2. Amity Institute of PharmacyINTRODUCTION-Pharmacopeia.
❑A book or publication, usually published by the
government or a recognized authority, that contains
a collection of standards, specifications, and test
methods for the quality control of medicines."
Examples:
❑1. United States Pharmacopeia (USP): Published by the
United States Pharmacopeial Convention.
❑2. British Pharmacopoeia (BP): Published by the British
Pharmacopoeia Commission.
❑3. European Pharmacopoeia (Ph. Eur.): Published by the
European Directorate for the Quality of Medicines.
❑4. Indian Pharmacopoeia (IP): Published by the Indian
Pharmacopoeia Commission.
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3. Amity Institute of PharmacyINTRODUCTION-Monographs
❑A monograph in pharmacy isa scientific document that
provides information about a drug or class of drugs.
❑It includes details on the drug's properties, uses, and safety.
❑Monographs are used to ensure that drugs meet quality
standards and are safe for use.
❑The first pharmacopoeia monographs are considered to have
been introducedaround the mid-16th century, with the
publication of the "Dispensarium" by Pierre de Villeneuve in
1543, which contained original drug recipes and marked a
significant step towards standardized drug formulations.
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4. Amity Institute of PharmacyINTRODUCTION-USP-NF
❑TheUnited States Pharmacopeia(USP) is
apharmacopeia(compendium ofdruginformation) for the
United States published annually by the over 200-year old
USP is a set of quality standards for medicines that are
marketed in the United States.
USP standards are used to ensure the quality of medicines
and their ingredients.
❑National Formulary(NF): NF contains official standards for the
quality, purity, and identity of excipients, which are inactive
ingredients used in medicines.
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5. Amity Institute of PharmacyINTRODUCTION-USP-NF
➢The United States Pharmacopeia – National Formulary (USP-NF)
includes over 5000 quality standards for medicines, both chemical and
biologic; active pharmaceutical ingredients (APIs); and excipients
(inactive ingredients). It is the most comprehensive source for
medicine quality standards in the world. The standards in USP-NF are
used to help ensure the quality of medicines and their ingredients, and
to protect the safety of patients.
USP-NF includes three types of quality standards for prescription
medicines:
➢Monographsarticulate the quality expectations for a medicine
including for its identity, strength, purity, and performance. They also
describe the tests to validate that a medicine and its ingredients meet
these criteria.
➢General Chaptersprovide broadly applicable information to industry
on accepted processes, tests and methods to support product
development and manufacturing for innovative, genericand biosimilar
medicines.
➢Material reference standardsare used in conjunction with
monographs and general chapters to verify that a medicine and its
ingredients can pass tests to ensure adherence to quality
requirements.
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6. Amity Institute of PharmacyINTRODUCTION-USP-NF
➢A monograph is a written document that reflects the quality attributes of medicines
approved by the U.S. Food and Drug Administration (US FDA). Some of these
attributes include:
Identity -Tests to identify that a particular substance is the medicine that it claims
to be.
Strength -Testing methods and acceptable ranges for the potency of a medicine,
as reflected in FDA's approvals. For example, this indicates the amount of API in a
medicine.
Purity -Information on impurities that may be present in a medicine and the
amounts of these that are permitted, along with testing methods to identify and
measure them. An impurity is any component in the API or finished dosage form
which is not the desired product or other formulation components.Levels that
exceed may present patient safety concerns.
Performance -Laboratory tests to predict and demonstrate how a medicine will be
released as it enters the human body.
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7. Amity Institute of PharmacyMONOGRAPHS
➢CHANGE / UPDATE IN MONOGRAPHS.
➢New FDA approvals- Monographs are updated when FDA approves medicines
with new or different quality specifications than those expressed in an existing
monograph.
Changes requested by FDA or others based on safety data- A monograph may be
revised to reflect new data or science, subsequent to FDA product approval or
monograph publication.
➢Advances in technology- Monographs are revised to reflect new testing and
manufacturing technologies.
➢Monograph revisions can be requested by any stakeholder including industry and
FDA.
➢The United States Pharmacopeia (USP) is continuously revised, with updates
presented three times a year in the USP-NF as Issues 1, 2, and 3, and as monthly
Accelerated Revisions on the USP website.
➢- February 11, 2025: A Notice of Intent to Revise was posted for <382>
Elastomeric Component Functional Suitability in Parenteral Product
Packaging/Delivery Systems ².
➢- February 3, 2025: A Notice of Intent to Revise was posted for Teriflunomide and
Teriflunomide Tablets ².
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8. Amity Institute of Pharmacy
USP Herbal Medicines Compendium (HMC)U
USP Herbal Me iUSP-Herbal Medicine Compendium(HMC)
USP Herbal Medicines
Compendium (HMC)

9. Amity Institute of PharmacyMONOGRAPH - Detail

10. Amity Institute of PharmacyMONOGRAPH - Detail

11. Amity Institute of PharmacyMONOGRAPH - Detail

12. Amity Institute of PharmacyMONOGRAPH - Detail

13. Amity Institute of PharmacyQUIZ
Q1) What is the primary purpose of USP monographs?
A) To provide marketing information for pharmaceuticals
B) To establish standards for pharmaceutical quality
C) To provide dosage instructions for patients
D) To list side effects of medications
Q2) What is the typical revision cycle for USP monographs?
A) Every 2-3 years
B) Every 5-7 years
C) Every 10-12 years
D) Every 15-20 years
Q3) Which of the following is NOT a typical section found in a USP monograph?
A) Identification
B) Assay
C) Impurities
D) Marketing Information
Q4) Which organization is responsible for publishing USP?
A) United States Food and Drug Administration (FDA)
B) United States Pharmacopeial Convention (USP)
C) Pharmaceutical Research and Manufacturers of America (PhRMA)
D) American Pharmacists Association (APhA)

14. Amity Institute of Pharmacy
Applications of Thin Layer Chromatography (TLC)
Question 5
What is the significance of the "USP" label on a pharmaceutical product?
A) It indicates that the product is manufactured in the United States
B) It indicates that the product meets USP standards for quality
C) It indicates that the product is approved by the FDA
D) It indicates that the product is available only by prescription
Question 6
How often are new USP monographs added?
A) Quarterly
B) Annually
C) Biennially
D) As needed
Q7)When does first monograph was published?
Q8.) Who can ask for revision of monographs?
Q9.) Name the active constituent of Banaba leaf and its specified limit.
Q10.) What are the contaminants found and their limits are specified in previous monographs?

15. Amity Institute of Pharmacy
References
.✓https://www.usp.org/about/public-policy/overview-of-monographs
✓https://www.slideshare.net/slideshow/monographs-of-herbal-drugs-ip-usp-ahp-
bppptx/257588095
✓https://hmc.usp.org/

16. Amity Institute of Pharmacy