Aquigen Bio Launches High-Purity Gefitinib EP Impurity A: Elevating Standards in Pharmaceutical Research

Pune, India - May 2025 - Aquigen Bio, a global leader in pharmaceutical reference materials and impurity profiling, proudly announces the release of its latest product: Gefitinib EP Impurity A. This compound is an essential analytical standard used in the development, validation, and quality assurance of Gefitinib, a widely prescribed EGFR inhibitor for treating non-small cell lung cancer (NSCLC).
As the pharmaceutical industry continues to raise the bar on quality and compliance, reliable access to highly pure and well-characterized impurities like Gefitinib EP Impurity A is critical. Aquigen Bio's latest offering is designed to support pharmaceutical manufacturers, CROs, and research institutions involved in drug development and regulatory submissions.

Understanding Gefitinib EP Impurity A
https://aquigenbio.com/product/gefitinib-ep-impurity-a/

Gefitinib EP Impurity A is one of the specified impurities listed in the European Pharmacopoeia (EP) monograph for Gefitinib. It plays a key role in impurity profiling and stability studies during the production of the active pharmaceutical ingredient (API). By monitoring and quantifying this impurity, researchers and manufacturers can ensure the safety, efficacy, and regulatory compliance of the final pharmaceutical product.

Product Highlights:

Chemical Name: 7-methoxy-6-[3-(morpholin-4-yl)propoxy]quinazolin-4(3H)-one
CAS Number: [CAS registered]
Purity: ≥98%
Analytical Data Included: HPLC, NMR, MS, COA
Packaging Sizes: Available in 10 mg, 25 mg, 50 mg, and 100 mg packs
Storage: Store in a cool, dry place; protect from light

The availability of this impurity in high purity enables precise and reproducible analytical testing, which is vital for maintaining the integrity of generic and branded Gefitinib formulations.

Why Impurity Profiling Matters in Pharmaceutical Development
Impurities can arise during synthesis, storage, or degradation of a pharmaceutical compound. Regulatory authorities such as the EMA, FDA, and ICH require comprehensive impurity profiling to ensure drugs are safe for human consumption.
Gefitinib EP Impurity A must be detected, quantified, and controlled within permissible limits throughout the drug's lifecycle. This ensures:
Patient safety by reducing toxicological risks

Therapeutic efficacy by maintaining the purity of the API
Regulatory compliance in accordance with pharmacopoeial standards

Aquigen Bio helps pharmaceutical scientists meet these goals by providing ready-to-use, validated impurity standards.

Applications of Gefitinib EP Impurity A
Aquigen Bio's Gefitinib EP Impurity A is suited for a range of laboratory applications, including:
Analytical Method Development

Supporting HPLC, UPLC, and LC-MS method validation
Defining specificity, accuracy, and robustness for impurity detection
Stability Testing
Assists in determining the shelf life and degradation profile of Gefitinib products
Regulatory Submissions
Includes complete documentation to facilitate DMF (Drug Master File) and ANDA (Abbreviated New Drug Application) filings
Quality Control (QC)
Utilized in batch release testing and specification setting for manufacturing

With global GMP and ICH compliance, Aquigen's impurity standards streamline workflows in R&D, QC, and regulatory departments.

Complementary Products in the Gefitinib Series
To offer a comprehensive impurity profiling suite, Aquigen Bio also provides several other impurities and related compounds in the Gefitinib family. These products are useful for thorough characterization and bioanalytical studies:
1. Gefitinib EP Impurity B
https://aquigenbio.com/product/gefitinib-ep-impurity-b/

Gefitinib EP Impurity B is another specified impurity in the EP monograph, relevant for stability and degradation pathway analysis. Often occurring during synthetic processing or under stress conditions, this impurity is crucial for assessing the drug's robustness and storage requirements.
2. Gefitinib d8
https://aquigenbio.com/product/gefitinib-d8/

This deuterated version of Gefitinib is widely used as an internal standard in LC-MS/MS assays. Its stable isotopic labeling allows for accurate quantification of Gefitinib in biological matrices, making it valuable in pharmacokinetic (PK) and bioequivalence (BE) studies.
3. 3-Desmorpholinyl-3-Hydroxyethylamino Gefitinib
https://aquigenbio.com/product/3-desmorpholinyl-3-hydroxyethylamino-gefitinib/

This compound is a key metabolite or degradation impurity of Gefitinib. It provides insight into the metabolic fate of the drug, helping researchers assess potential toxicity, efficacy, and formulation stability.
By combining these related impurity standards, researchers can perform comprehensive impurity mapping and method validation with confidence.

Why Choose Aquigen Bio?
Aquigen Bio has established itself as a trusted source of pharmaceutical reference materials by upholding the highest standards of quality, reliability, and scientific integrity. Here's what sets the company apart:
Strict Quality Control

All impurities undergo rigorous quality control including:
Nuclear Magnetic Resonance (NMR)
Mass Spectrometry (MS)
High-Performance Liquid Chromatography (HPLC)
Elemental analysis and stability testing

Global Regulatory Support
Each product is supplied with a Certificate of Analysis (COA) and full analytical data, ensuring smooth regulatory submissions for ANDA, NDA, or MAH applications.
Customization and Synthesis
Need a custom impurity or isotope-labeled compound? Aquigen's expert team offers custom synthesis services tailored to meet the specific demands of your project.
Rapid Global Shipping
With a streamlined supply chain and global logistics support, Aquigen Bio delivers to over 60 countries, ensuring timely availability for urgent R&D needs.

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 trusted manufacturer and global supplier of pharmaceutical impurities, isotope-labeled compounds, metabolites, and reference standards. Backed by a team of experienced scientists and a commitment to quality, Aquigen supports pharmaceutical companies, CROs, and academic institutions in over 60 countries. With a customer-first approach and dedication to scientific excellence, Aquigen Bio continues to drive innovation in analytical chemistry and regulatory science.

This release was published on openPR.