Unveiling Tegoprazan Impurity 2: A Critical Reference Standard in P-CAB Drug Development

As the pharmaceutical industry advances toward next-generation acid suppression therapies, potassium-competitive acid blockers (P-CABs) like Tegoprazan are emerging as game changers in the treatment of gastroesophageal reflux disease (GERD) and other acid-related conditions. However, to ensure the safety, efficacy, and regulatory compliance of P-CAB-based drugs, identifying and monitoring impurities during synthesis and storage is non-negotiable.

Explore Tegoprazan Category
https://aquigenbio.com/products/impurity-standards/tegoprazan/

One such critical impurity is Tegoprazan Impurity 2 - a process-related compound now available as a high-purity analytical reference standard through AquigenBio. Designed to support method development, regulatory filings, and quality assurance workflows, this impurity standard plays a pivotal role in maintaining pharmaceutical excellence throughout the lifecycle of tegoprazan-based formulations.

What Is Tegoprazan Impurity 2?

Tegoprazan Impurity 2 is a chemically distinct byproduct or intermediate that can arise during the multi-step synthesis of the API tegoprazan. While not therapeutically active, such impurities are essential to monitor in accordance with ICH Q3A/B guidelines and regulatory expectations from agencies like the FDA and EMA.

Offered by AquigenBio, this impurity is manufactured with a high level of purity and structural confirmation, including NMR, LC-MS, IR, and UV analysis. It comes with full documentation for analytical laboratories and formulation teams.
Key Product Overview: Tegoprazan Impurity 2
Product Link: https://aquigenbio.com/product/tegoprazan-impurity-2/

Product Name: Tegoprazan Impurity 2

CAS Number: 1640981-02-7
Molecular Formula: C18H20N2O4
Molecular Weight: 328.36 g/mol
Physical Form: Off-white to pale yellow solid
Purity: ≥ 95% (HPLC and NMR validated)

Applications:
Analytical method development
Routine quality control
Regulatory submissions
Stability and degradation studies

Documentation Provided:
Certificate of Analysis (CoA)
Safety Data Sheet (SDS)

Spectroscopic data (NMR, IR, MS)
Storage Conditions: 2-8°C, dry and away from light

Packaging: Customizable (mg to gram scale)

Availability: Global shipping with fast dispatch

Why Impurities Like Tegoprazan Impurity 2 Matter
Pharmaceutical impurities can arise from various sources including synthesis steps, raw materials, degradation, and storage. Regulatory agencies globally mandate the identification, qualification, and quantification of these impurities to safeguard human health.

Specifically, Tegoprazan Impurity 2 allows manufacturers and analytical teams to:
Ensure API consistency from batch to batch.

Avoid toxicological risk from unknown contaminants.

Align with ICH Q3A/B and M7 guidelines.

Maintain high analytical precision and regulatory readiness.

AquigenBio: A Global Provider of Impurity Standards
AquigenBio specializes in the synthesis and supply of high-quality impurity reference standards, including those related to emerging APIs like tegoprazan.

Their expertise spans across:
Impurity synthesis and characterization
Custom synthesis and scale-up
Deuterated compounds and nitrosamine standards
Rapid international delivery and documentation support

With a robust R&D backbone and customer-focused service, AquigenBio is a preferred partner for pharmaceutical QC labs, CROs, and formulators worldwide.
Related Products in the Tegoprazan Impurity Series
AquigenBio also offers other critical impurities in the tegoprazan impurity profile, helping clients cover all analytical bases.

Tegoprazan Nitroso Impurity 2
Product Link: https://aquigenbio.com/product/tegoprazan-nitroso-impurity-2/

Nitroso impurities, classified as genotoxic and potentially carcinogenic, have been a significant focus of recent regulatory alerts. Even at trace levels, these compounds must be identified and quantified during development and shelf-life studies.

Use Case:
Supports ICH M7 (R1) risk assessments
Used in nitrosamine control strategies
Purity: ≥ 95%
Ideal for:
LC-MS/MS method validation
Impurity profiling in final formulations
Documentation Provided:
CoA
SDS
Mass spec and NMR data
Storage: Store cold and protected from light

Tegoprazan Impurity 1
Product Link: https://aquigenbio.com/product/tegoprazan-impurity-1/

This compound is one of the primary process-related impurities in tegoprazan synthesis and is required for complete impurity profiling in any regulatory dossier.
Product Name: Tegoprazan Impurity 1
Purity: ≥ 95% (HPLC and NMR tested)

Structure Confirmed By:
LC-MS
NMR
IR

Applications:
Analytical method validation
Stress testing
Long-term stability studies
Documentation Provided: CoA, SDS, full analytical package
Storage Conditions: 2-8°C

Availability: Global delivery from AquigenBio warehouse

Analytical and Regulatory Benefits
Incorporating certified reference impurities like Tegoprazan Impurity 2 in your analytical program ensures:

Improved chromatographic selectivity
Robust method validation results
Easier preparation of regulatory filings (DMF, ANDA, NDA)
Confident quantification of known and unknown impurities
Greater reproducibility in stress and forced degradation studies

Whether you're preparing for a pre-approval inspection or simply strengthening your internal quality systems, these impurity standards provide the clarity and control your lab needs.

Custom Synthesis and Technical Support

Custom synthesis of novel or unknown impurities
Isotopically labeled standards (D, 13C)
Toxicological qualification support

Documentation tailored for IND/ANDA/NDA filings

Their expert team can synthesize milligram to kilogram quantities with full characterization.

Safety, Handling, and Storage
All impurity standards from AquigenBio come with full safety documentation. Key recommendations include:
Handle inside a fume hood
Wear gloves, goggles, and lab coat
Store at recommended temperature (usually 2-8°C)
Avoid moisture and direct sunlight exposure

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
AquigenBio is a leading life sciences company specializing in the synthesis, development, and global distribution of pharmaceutical impurity reference standards. Headquartered in Pune, India, with international reach, AquigenBio supports pharmaceutical manufacturers, CROs, and research institutions in ensuring regulatory compliance, analytical accuracy, and quality assurance throughout the drug development lifecycle.

This release was published on openPR.