Atypical Antipsychotic Medicines

Atypical antipsychotics play a vital role in the treatment of mental health conditions, offering hope and improved outcomes for millions. Yet, developing these medicines is anything but simple. With challenges ranging from low solubility and polymorphism to sensitivity to light and moisture, each step demands precision and care. 

USP is here to help you overcome these challenges. Our validated analytical methods, official monographs, and globally trusted reference standards are designed to simplify your workflow, support regulatory compliance, and give you confidence in every batch you produce. 

Now available: Brexpiprazole Reference Standard and proposed monograph developed to address poor solubility, photo instability, and known degradation pathways. With specified light protection protocols and procedures using mixed organic diluents, these resources can help bring new clarity and reliability to your analytical process.

 

Explore USP’s solutions for atypical antipsychotics:

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

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Excipients included with this molecule:

Aripiprazole

Aripiprazole

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters:

Excipients included with this molecule:

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI) 

Included Excipients 

Included General Chapters 

Brexpiprazole NEW

Brexpiprazole NEW

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Pharmaceutical Analytical Impurities (PAI) 

Included Excipients 

Included General Chapters 

Please note that some links below require a USP-NF account to access. “RS” refers to a “USP Reference Standard”.

Included General Chapters:

Excipients included with this molecule:

Lurasidone

Lurasidone

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Excipients included with this molecule:

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USP Monograph Olanzapine

Included General Chapters

Excipients Included with this molecule

Olanzapine

Olanzapine

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USP Monograph Olanzapine

Included General Chapters

Excipients Included with this molecule

Please note: some links below require a USP-NF account to access.

Included General Chapters

Included excipients

Paliperidone

Paliperidone

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Included General Chapters

Included excipients

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Included General Chapters:

Excipients Included with this molecule:

Risperidone

Risperidone

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Excipients Included with this molecule:

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Included General Chapters:

Excipients included with this molecule:

 

Quetiapine

Quetiapine

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Excipients included with this molecule:

 

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Ziprasidone

Ziprasidone

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Excipients included with this molecule:

Young woman with delusions screaming
Why Atypical Antipsychotics matter

Atypical antipsychotics, also known as second-generation antipsychotics, are key treatments for schizophrenia, bipolar disorder, and depression. Advanced formulations, including long-acting injectables, have helped improve patient adherence, reduce side effects, and support better outcomes

As awareness of mental health continues to grow, the demand for safe, quality, and effective generic atypical antipsychotics remains strong, to ensure broader access to essential therapies for those who need them most.

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Manufacturing & development complexities

Developing and manufacturing these medicines is highly complex due to low water solubility, the presence of multiple solid forms such as polymorphs, solvates, and hydrates, and photo‑instability that can lead to oxidation. 

Additional challenges include achieving optimal chromatographic separation and detection, degradation due to temperature, light, and moisture, and added formulation hurdles for long acting injectables that rely on specialized excipients like lactide and glycolide based polymers. Together, these factors can slow regulatory review and delay time to market

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What USP offers?

USP solutions help streamline development by providing validated analytical methods and official monographs including specifications for reliable and reproducible testing, along with reference standards and analytical reference materials (ARMs) to ensure confident identification and quantification of ingredients and impurities. 

USP also offers analytical guidance for complex dosage forms, including long‑acting injectables, to address formulation and stability challenges. Together, these resources support global regulatory expectations and help simplify each stage of your workflow.

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USP’s Brexpiprazole Reference Standard and proposed monograph:

Brexpiprazole development brings analytical challenges, and USP offers targeted tools to address them: 

  • Supports poor solubility with validated sample preparation in mixed organic diluents 
  • Reduces photodegradation through clear light‑protection instructions 
  • Guides complex impurity profiling with defined procedures for identifying and measuring degradation products 

These resources help manufacturers achieve consistent analysis and strong stability control throughout development.

Access now 

You might also be interested in:

USP solutions to navigate LG polymer formulations challenges in long‑acting atypical antipsychotics 

USP helps address naming issues, formulation complexity, and raw material variability in long acting injectables. We provide trusted reference standards, monographs, general chapters, stumili articles, ARMs, case studies, technical notes, peer reviewed articles, education, and practical resources, to support smoother development.

Explore more

USP Extractable and Leachable (E&L) solutions in protecting long‑acting injectables from packaging impurities 

Extractables and leachables from single use systems and packaging can introduce impurities that affect potency, stability, and safety of long acting injectables. With limited guidance, analysis is challenging. USP is developing a complete solution with general chapters, reference standards, ARMs, and technical resources to safeguard product from packaging impurities.

Learn more

FAQs 

How does USP help address poor solubility in atypical antipsychotics AA? 

USP methods specify mixed organic diluents, such as acetonitrile, methanol, with aqueous buffers, to achieve complete dissolution and stable chromatographic performance, even for drugs with low aqueous solubility. 

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Are there special handling requirements for Brexpiprazole? 

Yes. USP procedures in the proposed monographs for Brexpiprazole include explicit instructions to protect solutions from light, minimizing photodegradation, and helping to ensure accurate results. 

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Can USP support quality testing for long-acting injectables? 

Absolutely. USP provides guidance and standards for formulation and testing of long-acting injectables, including particle size considerations, release kinetics, and excipient selection, helping you address the unique challenges of these advanced dosage forms. 

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Why choose USP standards for atypical antipsychotics? 

USP standards help simplify development, support regulatory compliance, and help you deliver safe, effective medicines, giving you confidence in every batch and accelerating your path to market.

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woman scientist in lab

Ready to take the next step? 

USP is committed to supporting your journey from development to delivery. Explore our portfolio, sign up for updates, or contact us for more information.

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