Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
Therapeutic Drug Monitoring: Drug Analysis Methods01:26

Therapeutic Drug Monitoring: Drug Analysis Methods

Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

APRIL-targeted and dual BAFF/APRIL blockade in primary IgA nephropathy: a systematic review and meta-analysis of randomized placebo-controlled trials.

International urology and nephrology·2026
Same author

Identification of MMP14 and FOS as key regulators of vascular smooth muscle cell senescence in diabetic kidney disease: A combined bioinformatics and experimental study.

Archives of gerontology and geriatrics·2026
Same author

Defining and validating the minimal clinically important difference for the cough severity visual analogue scale in adults with subacute cough.

Heart & lung : the journal of critical care·2026
Same author

Impact of Comorbid Interstitial Lung Abnormalities on Acute Exacerbations of COPD: A Hospital-Based Retrospective Cohort Study.

COPD·2026
Same author

Therapeutic Mechanism of Yihuo Huatan Formula in Stable Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial Integrating Metabolomics and 16S rRNA Gene Sequencing.

Chinese journal of integrative medicine·2026
Same author

Effects of stand age on community composition and diversity of soil bacteria and fungi in poplar plantations in Northeast China.

Frontiers in plant science·2025

Related Experiment Video

Updated: Jul 18, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

Impurity profile tracking for active pharmaceutical ingredients: case reports.

Lili Zhou1, Bing Mao, Robert Reamer

  • 1Merck Research Laboratories, Early Development Analytical Research, P.O. Box 2000, RY818-B225, Rahway, NJ 07065, USA. lili_zhou@merck.com

Journal of Pharmaceutical and Biomedical Analysis
|December 5, 2006
PubMed
Summary

A systematic approach for tracking active pharmaceutical ingredient (API) impurity profiles is presented. This method utilizes reversed-phase high-performance liquid chromatography (RP-HPLC) and mass spectrometry for drug development.

More Related Videos

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
10:17

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

Development of Inhibitors of Protein-protein Interactions through REPLACE: Application to the Design and Development Non-ATP Competitive CDK Inhibitors
10:33

Development of Inhibitors of Protein-protein Interactions through REPLACE: Application to the Design and Development Non-ATP Competitive CDK Inhibitors

Published on: October 26, 2015

Related Experiment Videos

Last Updated: Jul 18, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
10:17

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

Development of Inhibitors of Protein-protein Interactions through REPLACE: Application to the Design and Development Non-ATP Competitive CDK Inhibitors
10:33

Development of Inhibitors of Protein-protein Interactions through REPLACE: Application to the Design and Development Non-ATP Competitive CDK Inhibitors

Published on: October 26, 2015

Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Sciences
  • Drug Development

Background:

  • Impurity profiling is critical throughout drug development for ensuring safety and efficacy.
  • Establishing robust methods for tracking impurities in active pharmaceutical ingredients (APIs) is essential.
  • Novel APIs require validated analytical strategies for comprehensive impurity characterization.

Purpose of the Study:

  • To describe a systematic approach for tracking the impurity profile of APIs.
  • To demonstrate the application of this strategy using three novel APIs: MK-0969, MK-0677, and API-A.
  • To evaluate techniques for peak purity assessment in impurity analysis.

Main Methods:

  • Development of a reversed-phase high-performance liquid chromatography (RP-HPLC) method through screening of stationary phases and mobile phase pH.
  • Structure elucidation of impurities using liquid chromatography-mass spectrometry (LC-MS), preparative LC, and nuclear magnetic resonance (NMR).
  • Assessment of peak purity using LC-UV diode-array and LC-MS detection.

Main Results:

  • Successful impurity profile tracking was achieved for three distinct novel APIs.
  • A comprehensive strategy combining RP-HPLC, LC-MS, preparative LC, and NMR was effectively demonstrated.
  • Comparative analysis of LC-UV diode-array and LC-MS for peak purity evaluation was conducted.

Conclusions:

  • The presented systematic approach provides a reliable framework for API impurity profiling.
  • The integrated analytical techniques enable thorough characterization and tracking of impurities during drug development.
  • Understanding the strengths and limitations of peak purity assessment methods is crucial for data integrity.