Aquigen Bio Strengthens Its Impurity Standards Portfolio with High-Quality Donepezil Impurities

Pune, India - 12/05/2025 - Aquigen Bio, a leading supplier of pharmaceutical impurity standards, has announced the expansion of its product line with the addition of Donepezil and its key impurities - Donepezil 3-Hydroxy Impurity and Donepezil 4-Hydroxy Impurity. This addition reinforces Aquigen Bio's commitment to providing the pharmaceutical industry with high-quality, reliable impurity standards for analytical, quality control, and regulatory needs.
Donepezil, a widely prescribed acetylcholinesterase inhibitor, is a cornerstone in the treatment of Alzheimer's disease and dementia. As with all active pharmaceutical ingredients (APIs), the presence, identification, and quantification of impurities are essential to ensure drug safety and efficacy.

To know more about Donepezil Impurities :
https://aquigenbio.com/products/impurity-standards/donepezil/

Aquigen Bio's new offerings aim to support formulators, analytical laboratories, and regulatory departments in maintaining the highest quality benchmarks in Donepezil manufacturing and testing.

Understanding Donepezil and Its Impurity Profile

Donepezil hydrochloride is an FDA-approved drug used primarily in the symptomatic treatment of Alzheimer's disease. It works by enhancing cholinergic function by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by acetylcholinesterase. With increasing demand for CNS drugs globally, Donepezil has become a critical molecule in the neurological drug segment.

As with any API, the synthesis and formulation processes for Donepezil can lead to the formation of process-related or degradation impurities. These impurities can impact the safety and stability of the final drug product. Therefore, regulatory bodies such as the USFDA, EMA, and ICH mandate detailed impurity profiling and qualification, especially for known and unknown impurities above the reporting thresholds.

Among the known impurities in Donepezil formulations, Donepezil 3-Hydroxy Impurity and Donepezil 4-Hydroxy Impurity are significant. These are hydroxylated analogs of Donepezil and can result from oxidation or intermediate transformation during synthesis. Reliable standards for these impurities are critical for method development, validation, routine testing, and regulatory submissions.

Aquigen Bio's High-Purity Donepezil Impurity Standards
Aquigen Bio has developed and characterized Donepezil 3-Hydroxy Impurity and Donepezil 4-Hydroxy Impurity with rigorous attention to quality and analytical accuracy. These impurity standards are synthesized in a controlled environment and validated with advanced analytical methods such as NMR, IR, LC-MS, and HPLC to ensure structural integrity, purity, and traceability.

Product Highlights:
Donepezil 3-Hydroxy Impurity
CAS No: [Insert if applicable]
Purity: ≥ 98%
Applications: Method validation, reference standard, impurity profiling
Packaging: 10 mg, 25 mg, custom packs available
https://aquigenbio.com/product/donepezil-3-hydroxy-impurity/

Donepezil 4-Hydroxy Impurity
CAS No: [Insert if applicable]
Purity: ≥ 98%
Applications: Regulatory submission, ICH stability studies, analytical control
Packaging: 10 mg, 25 mg, custom packs available
https://aquigenbio.com/product/donepezil-4-hydroxy-impurity/

Each product comes with a Certificate of Analysis (COA) that includes detailed characterization data, ensuring regulatory compliance and confidence in analytical procedures.

Why Impurity Standards Matter in Donepezil Formulations
The therapeutic value of Donepezil relies not only on the effectiveness of the active ingredient but also on the control of impurities present in the final product. Undetected or unqualified impurities may lead to adverse events or loss of efficacy. As regulatory frameworks tighten globally, pharmaceutical companies must demonstrate stringent impurity profiling using certified reference materials.

Donepezil 3-Hydroxy Impurity and Donepezil 4-Hydroxy Impurity, being potential process or degradation products, are crucial to monitor throughout drug development and manufacturing. Analytical methods such as HPLC, LC-MS/MS, and GC-MS require high-quality impurity standards to ensure accurate detection and quantification.

By supplying these impurity standards, Aquigen Bio enables pharmaceutical companies to:

Achieve precise analytical results for Donepezil formulations
Validate and maintain robust impurity profiling methods
Comply with ICH Q3A and Q3B guidelines
Ensure regulatory approval readiness

Trusted by Global Pharmaceutical Leaders

Aquigen Bio's impurity standards are widely used by pharmaceutical manufacturers, contract research organizations (CROs), and analytical testing laboratories worldwide. With strict adherence to international quality norms and a focus on reliability, the company has positioned itself as a trusted partner for regulated markets including the US, EU, and Asia-Pacific regions.
The introduction of Donepezil, Donepezil 3-Hydroxy Impurity, and Donepezil 4-Hydroxy Impurity is a strategic move that reflects Aquigen Bio's agility in responding to industry needs and regulatory changes.

To know more about Donepezil Impurity :
https://aquigenbio.com/product/donepezil/

Customer-Centric Solutions

Aquigen Bio not only offers off-the-shelf impurity standards but also provides:

Custom synthesis of rare or unknown impurities
Analytical support and impurity identification services
Stability studies under ICH conditions
Documentation assistance for regulatory filings

With a team of experienced chemists, analysts, and regulatory specialists, Aquigen Bio is equipped to deliver tailor-made impurity solutions with fast turnaround and complete traceability.

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
Aquigen Bio is a research-driven company specializing in the development, synthesis, and supply of pharmaceutical impurities, reference standards, metabolites, and intermediates. Headquartered in Hyderabad, India - one of the world's major pharma hubs - Aquigen Bio collaborates with global pharma and biotech companies to enhance drug safety, compliance, and innovation.
Our mission is to support pharmaceutical R&D and quality control efforts through:

High-purity impurity standards for critical APIs
End-to-end characterization and certification
Fast shipping and responsive customer service
Ongoing commitment to quality, consistency, and innovation

With a portfolio spanning thousands of impurity standards across therapeutic categories, Aquigen Bio continues to build trust among leading pharmaceutical companies and regulatory authorities.

This release was published on openPR.