AquigenBio Introduces High-Purity Daridorexant Hydrochloride to Support Sleep Disorder Research and Analytical Development

India - August 2025 - AquigenBio, a premier provider of pharmaceutical reference standards and impurity profiling solutions, proudly announces the release of Daridorexant Hydrochloride (CAS No. 1792993-84-0). This high-quality, precisely characterized compound is a hydrochloride salt form of Daridorexant, a dual orexin receptor antagonist with proven efficacy in the treatment of insomnia.

Explore Daridorexant Hydrochloride -
https://aquigenbio.com/product/daridorexant-hydrochloride/

The launch of this product marks a significant addition to AquigenBio's growing portfolio of sleep therapy-related reference materials, which includes both the base form of Daridorexant and key structural impurities designed for use in regulatory compliance, formulation research, and pharmacological development.

Scientific and Clinical Relevance of Daridorexant
Daridorexant, the active pharmaceutical ingredient in the approved sleep aid Quviviq®, operates through a novel mechanism of action. Unlike traditional hypnotics that enhance GABAergic inhibition (such as benzodiazepines or Z-drugs), Daridorexant selectively blocks the binding of wake-promoting neuropeptides (orexin A and B) to their respective receptors (OX1 and OX2). This dual antagonism reduces excessive wakefulness and facilitates both sleep onset and maintenance, with minimal disruption to sleep architecture.

Clinically, Daridorexant has shown efficacy in reducing sleep onset latency, decreasing wake time after sleep onset, and improving patient-reported daytime functioning. Its relatively short half-life (~8 hours) and lack of significant next-day sedation distinguish it as a safer alternative for chronic insomnia management. Regulatory approvals in the U.S. (FDA, January 2022) and Europe (EMA, April 2022) underscore its growing acceptance in clinical practice.

Product Overview: Daridorexant Hydrochloride
AquigenBio's Daridorexant Hydrochloride is synthesized and purified under stringent quality control protocols. The product is suitable for a range of pharmaceutical R&D applications, including analytical method development, formulation studies, impurity identification, pharmacokinetic modeling, and stability testing.

Key details:
CAS Number: 1792993-84-0
Form: High-purity hydrochloride salt, suitable for laboratory use
Applications:
Reference standard for analytical and chromatographic method development
Source material for formulation compatibility and stability studies
Structural reference for impurity profiling and degradation studies

Each batch is delivered with a comprehensive Certificate of Analysis (COA), confirming purity, identity, and analytical traceability, supporting use in both preclinical and regulatory environments.

Daridorexant Impurity Standards
In addition to the hydrochloride salt, AquigenBio maintains a specialized category of Daridorexant impurity standards. These compounds are critical for method validation, forced degradation studies, and impurity threshold assessment during drug development and manufacturing.

The impurity standards support regulatory submissions and ICH-compliant quality assurance processes. Their availability ensures that pharmaceutical developers can confidently meet specifications regarding known, unknown, and potentially mutagenic impurities.

This category includes:
https://aquigenbio.com/products/impurity-standards/daridorexant/

Impurities formed during synthesis

Degradation products observed under stress conditions

Structural analogs and process-related compounds

Nitrosamine-related impurities

These impurity materials are manufactured with high spectral characterization and are shipped with appropriate documentation to meet regulatory expectations globally.

Related Products
1. Daridorexant (Base API)
AquigenBio also offers the base form of Daridorexant (CAS No. 1505484-82-1), which is particularly useful in comparative studies where neutral or salt-free conditions are required. This form is commonly used in solubility profiling, pharmacokinetic evaluations, and formulation optimization for oral dosage forms.

Its structural similarity to the hydrochloride salt ensures relevance in cross-validation studies while enabling flexibility for developers testing different salt forms or delivery mechanisms.

https://aquigenbio.com/product/daridorexant/

2. Daridorexant N-Nitroso Impurity
This compound is a specially synthesized N-nitroso derivative of Daridorexant. Nitrosamines are increasingly under regulatory scrutiny due to their potential carcinogenicity, and this impurity standard enables laboratories to develop and validate detection methods for nitrosamine contaminants.

Designed to support limit testing and quantification per evolving regulatory guidelines (such as those issued by the EMA, FDA, and WHO), this impurity is essential for ensuring patient safety and maintaining the integrity of drug substance manufacturing.

It also plays a critical role in stress-testing and degradation pathway elucidation, especially when developing robust analytical methods for stability-indicating assays.

https://aquigenbio.com/product/daridorexant-niroso-impurity/

Advantages for Researchers and Developers
By offering both the primary drug substance and its structurally related impurities, AquigenBio provides an integrated solution for researchers and formulators working in the sleep therapeutics domain. This enables pharmaceutical developers, CROs, and academic institutions to streamline their workflows across discovery, development, and regulatory phases.

The availability of impurity standards and the active molecule in multiple forms ensures that clients can:

Develop and validate analytical methods with high confidence

Comply with ICH and regional impurity guidelines

Investigate degradation pathways and impurity risks early

Assess formulation stability and bioavailability of different salt forms

Perform comprehensive toxicological assessments of related compounds

Commitment to Quality and Support
Each product undergoes stringent testing and validation. Clients receive not only high-purity materials but also dedicated technical support, ensuring the right fit for their specific application-whether it's for chromatographic method development, impurity profiling, or reference standard validation.

AquigenBio maintains a global logistics network to ensure timely delivery of all research and impurity standards. Batch sizes are scalable, with options for small R&D trials to larger GMP-compliant manufacturing needs.

In addition, all products are accompanied by:

Certificate of Analysis (COA)

Analytical chromatograms

Storage and handling guidelines

Spectral data (where applicable)

About Daridorexant and Sleep Medicine Research
The increasing prevalence of chronic insomnia, particularly in aging populations, has led to a surge in demand for novel and safer sleep therapeutics. As a non-sedative, non-benzodiazepine agent, Daridorexant offers unique advantages in preserving natural sleep cycles while minimizing the risk of dependence, tolerance, and residual sedation.

This therapeutic profile makes Daridorexant not only a drug of high clinical relevance but also a critical molecule for ongoing pharmaceutical research-spanning the fields of neuropharmacology, chronobiology, and CNS drug delivery.

With several orexin receptor antagonists now under development, reference materials such as Daridorexant Hydrochloride and its associated impurities are essential tools for both competitive benchmarking and regulatory compliance.

Contact:
Aquigen Bio Sciences
281/1, Plot No 41,
Hinjawadi - Pirangut Rd,
Kasar Amboli, Pirangut,
Pune, Maharashtra 412108
Phone: +91 7030123794
Email: bd@aquigenbio.com
Visit: www.aquigenbio.com

About Aquigen Bio Sciences
Aquigen Bio Sciences is at the forefront of pharmaceutical excellence, serving as the leading resource for daridorexant impurity standards in India. With a strong commitment to safety, innovation, and regulatory compliance, the organization specializes in impurity profiling, synthesis, and analysis, empowering pharmaceutical manufacturers globally with premier standards. Aquigen Bio Sciences' dedication to cutting-edge research ensures it remains a trusted partner in refining quality benchmarks across the pharmaceutical landscape.

This release was published on openPR.