Steering you through the maze of advanced injectables
Steering you through the maze of advanced injectables

Steering you through the maze of advanced injectables

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Injectables

The rising demand for and widespread use of sterile injectable drug formulations is driven by the growth of biopharmaceuticals, enhanced bioavailability through bypassing the digestive system, and advancements in drug delivery technologies such as long-acting injectables -- all aligned with evolving patient needs. 

However, manufacturing injectable formulations presents significant challenges, including: 

  • Complex formulation requirements
  • Use of complex active pharmaceutical ingredients (APIs)
  • The need for detailed characterization of intricate drug delivery and release systems
  • Potential contamination introduced from manufacturing and packaging components
  • Meeting regulatory expectations

Navigate to: 

USP has an expanding suite of monographs, general chapters, Reference Standards (RSs), and Analytical Reference Materials (ARMs*) to help you mitigate quality and regulatory risks for your injectable drug products.

Important dates – compliance changes: 

USP General Chapters

General Chapters 

USP General Chapters provide methods and guidelines across all steps of the injectables manufacturing process from raw materials receiving and testing to dispensing to filtration to sterilization to lyophilization to testing to batch release to distribution. 

See some examples

Solutions for Small Molecules

Maintaining API quality and integrity in complex small molecule injectable formulations is essential throughout the shelf-life of the drug. This becomes especially critical when the API is hydrophobic, enantiomeric, prone to degradation, or exhibits other structural complexities. USP offers an array of solutions to turbocharge your analytical research, quality, and stability testing of small molecule APIs and injectable drug formulations with certainty and confidence: 

  • 1000+ official USP monographs and general chapters for small molecule injectables (visit USP-NF online)
  • USP RSs and ARMs for APIs and impurities (buy now)

Excipients Essentials

Delivery and Release agents

Drug Delivery and Release Agents 

  • Lactide and Glycolide (LG) Polymers
  • Phospholipids 

USP offers an expanding suite of solutions that will help you meet regulatory expectations and overcome characterization challenges of LG polymers and phospholipids used in microspheres and nanospheres in complex generics and new formulations. 

Learn more about LG Polymers

Learn more about Phospholipids

Surfactants and Preservatives

Surfactants and Preservatives

USP has monographs for widely used surfactants like cholesterol, polysorbates, etc and 70+ RS supporting the monographs. 

Buy now

USP has monographs for widely used preservatives like methylparaben, benzyl alcohol, benzalkonium chloride, etc and 25+ RS supporting the monographs. 

Buy now 

Browse all Excipients RS

Contamination Control

Confidence and certainty about drug impurities

Confidence and certainty about drug impurities 

In drug development and manufacturing, impurities pose risks when detected above acceptable levels. It’s crucial for manufacturers to limit impurity levels early and throughout the product lifecycle. 

USP’s impurities solutions

Controlling Extractables & Leachables (E&L)

Controlling Extractables & Leachables (E&L)

Regulations require that substances migrating from packaging materials into drug products remain below harmful levels. E&L impurities linked to pharmaceutical manufacturing and packaging can adversely impact drug potency, stability, safety and quality if not properly analyzed. 

USP’s E&L solutions

Particulate Matter testing solutions

Testing for Particulate Matter

USP general chapters (<1787>, <1788>, <1790>, and <787> to <790>) and USP Particle Count Set RS help ensure suitability of your particle count testing setup and test for particulate matter, thereby helping you meet regulatory requirements and avoiding remediation costs.

Learn more (download brochure)

Endotoxins testing solutions

Endotoxins Testing Solutions 

Endotoxin contamination, even in very low amounts, can lead to serious health issues, and must be controlled. 

USP offers two general chapters with methods to test endotoxin. <86> Bacterial Endotoxins Test Using Recombinant Reagents and <85> Bacterial Endotoxins Test. 

Buy USP Endotoxin RS

Microbiological control solutions

Microbiological Control Solutions

Reliable microbiological quality control solutions are essential to help reduce contamination risk, support quality, and safeguard patient safety. USP now offers tools to enhance microbial contamination control in manufacturing and compounding, based on innovative preservation technology. 

Learn more

Biologics

Monoclonal antibody solutions

Monoclonal Antibody Solutions 

Monoclonal antibodies (mAbs) have complex attributes that must be rigorously assessed to ensure safety and efficacy. USP’s mAb Reference Standards support faster development and market entry by enabling efficient method validation. Incorporating these tools into your workflow ensures consistent quality throughout the mAb lifecycle. 

Learn more

AAV-based Gene Therapy materials

AAV-based Gene Therapy Materials 

USP’s new AAV-based gene therapy package contains resources that can help manufacturers standardize quality assessment and control throughout the production lifecycle, from raw and starting materials to release and stability. These standardized analytical methods and appropriately qualified materials can support efficient product development and characterization. 

Learn more

Peptide Family Solutions

Peptide Family Solutions 

USP peptide families consist of peptide API plus related impurity reference standards and Analytical Reference Materials. These resources can be used to develop and validate analytical methods, verify that compendial methods are fit for purpose in your laboratory, qualify equipment as well as control the quality of drug substance and product batches. 

Learn more

USP Education
USP Education

Drawing on our subject matter expertise and robust training capabilities, we offer comprehensive courses covering general chapters and key topics related to injectables.

Technical services
Technical services

Questions about USP's solutions for injectable drug formulations?

Contact USP Technical Services at:

AMTech@usp.org (for USP ARMs, e.g., PAIs) 
RSTech@usp.org (for USP RS)

*Analytical Reference Materials (ARM) (e.g., Pharmaceutical Analytical Impurities (PAIs)) are released using a process developed by USP’s subject matter experts. The release process is based on internal policies, standard operating procedures, and requirements as defined by USP’s Quality Management System. USP is an ISO 9001:2015 certified facility. ARMs are different from official USP Reference Standards. ARMs are not required for compendial compliance.