What is a monograph drug substance?

Drug monograph means the informational documents that are provided every time a new medication is ordered for a patient that contains specific drug-related uses, warnings, side effects and other information, depending on the medication dispensed.

What is NF monograph?

What is USP-NF? USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP.

What are the contents of monograph?

Monograph components

Title Page. Every thesis must have a title page.
Table of Contents. The Table of Contents should be detailed and include:
List of Tables. Provide a separate page with a list of tables used in the text.
List of Figures.
Legend.
Abstract.
The Acknowledgements or Preface.
Copyrighted Contents.

Why are monographs important?

Monographs are used as reference sources to build bibliographies and discover relevant references. They are also important as syntheses of literature in the field, valued for their comprehensive, in-depth, and definitive perspectives.

What is monograph in pharmacognosy?

A publication that specifies for a drug (or class of related drugs) the kinds and amounts of ingredients it may contain, the conditions and limitations for which it may be offered, directions for use, warnings, and other information that its labeling must contain.

What is the difference between USP and NF grade?

USP grade meets the purity levels set by the United States Pharmacopeia (USP). USP grade is equivalent to the ACS grade for many drugs. NF grade is a purity grade set by the National Formulary (NF). NF grade is equivalent to the ACS grade for many drugs.

How do you write a drug monograph?

Patient Information:

Name and description of the medication.
Dosage form.
Route of administration.
Duration of therapy.
Special directions and precautions.
Side effects.
Techniques for self-monitoring.
Proper storage.

What is monograph in pharmaceutical analysis?

The GPhP guidance continues, “Pharmacopoeial monographs provide an important tool for assurance of the quality of marketed pharmaceutical ingredients and products through testing of their quality.” These monographs are generally available for excipients, drug substances, and drug products, providing the tests.

What is a USP monograph?

USP Monographs for Bulk Drug Substances and Other Ingredients provide standards for identity, quality, purity, strength, packaging and labeling for bulk substances and other ingredients that may be used in compounded preparations. These monographs appear in the USP–NF.

What does USP24 stand for?

USP Standards for Packaged Purified Water, Water for Injection, and Sterile Purified Water (USP24 effective 1/1/00). USP24 contains complete versions of all pharmaceutical water monographs p. 1752-1754 and the general chapters <643> TOC, <645> Water Conductivity p. 1927-1929, and <1231> Water for Pharmaceutical Purposes p. 2154-2163.

What are USP monographs for bulk drugs and other ingredients?

What is the USP pending monograph program?

Through the USP Pending Monograph Program (PMP), monographs are updated rapidly prior to FDA approval. Through the PMP, USP works with the sponsor of a medicine under FDA review for approval, so that the monograph reflects the medicine’s quality specifications as soon as it receives market approval from FDA. Monographs revised through the PMP

What is a drug monograph?

Monographs help secure the global drug supply chain USP’s monographs are used by customs and border officials and public health and law enforcement authorities to confirm the quality of medicines and their ingredients from overseas sources.

What is a monograph drug substance?