Phospholipids

With lipid nano-particles (LNPs) emerging as the go-to drug delivery vehicle, accurate phospholipids characterization and nomenclature are of utmost importance. Phospholipids are critical building blocks for liposomal/LNP-based small molecule, mRNA, siRNA drugs, and vaccines, aiding in cellular delivery, stability, and safety. Despite these benefits, inconsistent nomenclature, and lack of characterization standards, materials, and methods for phospholipids slow LNP adoption in drug formulations.

Accurate phospholipids profiling in innovator and complex generic formulations demands robust tools for analytical reproducibility and confidence. USP's comprehensive standards and solutions can empower you to meet regulatory requirements and tackle characterization challenges with confidence and precision.

Why use USP Phospholipid standards and solutions?

A single trusted source for all your needs:

Support at every stage: From drug development to manufacturing, our high-quality solutions can help you stay on track at every step.
Confidence in your results: Our standards and solutions can help provide accurate analytical results and bring uniformity in testing and evaluating innovator or generic drugs.
Reduce risks and time to market: Product recalls can be costly and delay time to market. Our expert-approved standards and solutions can help minimize manufacturing risks and boost confidence to help your product stay on track.
Help meet regulatory requirements
Save resources and time

Explore USP’s robust Phospholipid standards and solutions that you can trust

Upcoming and published monographs in Pharmacopeial Forum (PF)

Soybean Phospholipids, PF48(2)
Soybean Phosphatidylcholine, PF49(3)
1,2-Distearoyl-sn-Glycero-3-Phosphocholine, PF49(6)
Sodium N-(Carbonyl-Methoxypolyethylene Glycol 2000)-1,2-Distearoyl-sn-Glycero-3-phospho-ethanolamine, PF51(3)
Hydrogenated Soybean Phospholipids, PF51(4)
Hydrogenated Soybean Phosphatidylcholine, PF51(4)

Upcoming Reference Standards (RS) and Materials

USP Phosphatidic Acid (Soy) Monosodium RS
USP Phosphatidylcholine (Soy) RS
USP Phosphatidylethanolamine (Soy) RS
USP Phosphatidylinositol (Soy) Sodium RS
USP Lysophosphatidylcholine (Soy) RS
USP N-Acylphosphatidylethanolamine (Soy) Ammonium RS
USP Phosphatidylcholine RS
USP Phosphatidylethanolamine RS
USP Lysophosphatidylcholine RS
USP 1,2-Distearoyl-sn-Glycero-3-Phosphocholine RS
USP 1-Stearoyl-sn-Glycero-3-Phosphocholine RS
USP MPEG-2000-DSPE RS
USP 1,2-Distearoyl-sn-Glycero-3-Phosphatidyl-ethanolamine RS
..and more

*Upcoming Analytical Reference Materials (ARMs)

Upcoming General Chapters

Coming soon: General chapter

^{*Analytical Reference Materials (ARMs) 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.}

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FAQs

What are LNPs?

Lipid nanoparticles (LNPs) are tiny spherical particles composed of lipids, which are fats or fat-like substances. They are primarily used as a drug delivery system in pharmaceuticals. LNPs can encapsulate and protect therapeutic agents, such as mRNA, ensuring they reach their target cells effectively.

LNPs gained significant attention during the COVID-19 pandemic as they were used to deliver mRNA in vaccines. These nanoparticles help stabilize the mRNA and facilitate its entry into cells, where it can then instruct the cells to produce the desired protein to trigger an immune response.

What is the composition of LNPs?

Lipid nanoparticles (LNPs) are composed of four main types of lipids:

Ionizable cationic lipids: Change charge with pH to encapsulate and release therapeutic agents.

Helper phospholipids: Stabilize the lipid bilayer and aid in delivery by disrupting the endosomal membrane.

Cholesterol: Enhances stability and fluidity, preventing leakage.

Polyethylene glycol (PEG) lipids: Increase stability and circulation time, reducing immune clearance.

What are the top challenges when working with Phospholipids?

Nomenclature and characterization challenges

Lack of standardized quality parameters

Knowledge gap delaying product development and approval of innovator and generic products

How can USP support your work using Phospholipids?

USP offers a suite of solutions including General Chapters, monographs, Reference Standards, Analytical Reference Materials etc. to navigate phospholipid complexities with confidence and ease.

Who can I contact to ask questions on Phospholipids?

Talk to our experts and learn how our solutions can support your every need

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