AquigenBio Launches High-Purity EP Impurity Standards for Propylthiouracil, Including Impurity A (Thiourea) and Impurity B (Methylthiouracil), to Support Analytical Testing, Method Validation, and Regulatory Compliance

AquigenBio is pleased to announce the availability of two essential impurity reference standards-Propylthiouracil EP Impurity A and Propylthiouracil EP Impurity B. These impurity standards are now available to support pharmaceutical companies, contract research organizations, and analytical laboratories engaged in drug development, quality control, and regulatory compliance.
Propylthiouracil (PTU) is a well-known antithyroid medication, widely used in the treatment of hyperthyroidism. In line with pharmacopeial guidelines, it is critical to identify and quantify impurities that may arise during its manufacturing or storage. The European Pharmacopoeia (EP) outlines the acceptable impurity profile for PTU, and AquigenBio's new impurity standards are specifically designed to meet those stringent requirements.

Propylthiouracil EP Impurity A - Thiourea
https://aquigenbio.com/product/propylthiouracil-ep-impurity-a/

Propylthiouracil EP Impurity A is chemically identified as thiourea, a known degradant and synthetic by-product associated with PTU. It is a small, sulfur-containing compound that must be monitored closely due to its potential biological activity and toxicological significance.
This impurity can be formed during the synthesis of propylthiouracil or during stability testing under certain environmental conditions such as heat, humidity, or oxidative stress. Regulatory authorities require its quantification and control during drug product development and production.
AquigenBio's reference standard for Impurity A is synthesized and purified under strict quality control systems. Each batch is supplied with a Certificate of Analysis (COA) and Safety Data Sheet (SDS), ensuring full traceability and compliance with international regulatory expectations. With this impurity standard, analytical chemists can confidently validate and execute impurity profiling methods such as HPLC, LC-MS, or UV-spectrophotometry for thiourea.

Propylthiouracil EP Impurity B - Methylthiouracil
https://aquigenbio.com/product/propylthiouracil-ep-impurity-b/

Propylthiouracil EP Impurity B, or methylthiouracil, is another critical secondary impurity associated with the propylthiouracil synthesis and degradation pathway. This compound is chemically more complex than thiourea and can appear in trace levels in active pharmaceutical ingredients (API) or formulated drug products.
Methylthiouracil is often detected under forced degradation studies and needs to be properly quantified in accordance with EP monographs. It may also be introduced during the synthetic process if reagents or reaction conditions are not tightly controlled.
AquigenBio's Impurity B standard is manufactured and qualified for use in analytical method development, system suitability testing, and regulatory submissions. It is provided in high-purity form, suitable for preparing calibration standards or spiking experiments in QC laboratories. This product plays an essential role in helping scientists ensure that their PTU products meet both internal quality standards and external regulatory thresholds.

Designed for Accuracy and Confidence
Both impurity standards are formulated for exclusive analytical use and are not intended for therapeutic or diagnostic applications. By providing these high-quality impurity reference standards, AquigenBio empowers pharmaceutical laboratories to carry out critical analytical functions, including:
Impurity profiling of raw materials, intermediates, and finished dosage forms

Method development and validation for analytical techniques such as HPLC and LC-MS
Stability studies and forced degradation tests
Routine quality control of production batches
Regulatory filings requiring full impurity characterization

These impurity standards are a key component of quality risk management and regulatory compliance for pharmaceutical companies working with propylthiouracil or related compounds.

The Role of Impurities in Drug Safety and Efficacy
In pharmaceutical science, impurities-whether process-related or degradation-related-can impact the safety, efficacy, and stability of drug products. Regulatory agencies such as the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) emphasize the need to monitor impurities and define clear limits based on toxicological data.

For propylthiouracil, impurities like thiourea and methylthiouracil must be monitored under ICH Q3A and Q3B guidelines. Even at low concentrations, such impurities may influence the pharmacological profile or cause unwanted side effects if left unquantified. Hence, their accurate identification and quantification are not just regulatory obligations-they are essential to ensuring patient safety and product reliability.

Explore Propylthiouracil Impurities
https://aquigenbio.com/products/impurity-standards/propylthiouracil/

By offering these EP-compliant standards, AquigenBio helps researchers and quality assurance teams maintain the highest level of product integrity.

Supporting Global Pharmaceutical Operations
AquigenBio's reference standards are available globally and can be rapidly dispatched to pharmaceutical companies, CROs, CMOs, academic institutions, and independent laboratories. With a strong commitment to quality, consistency, and scientific excellence, AquigenBio has earned the trust of professionals seeking reliable impurity standards for critical applications.
Each impurity standard undergoes rigorous analytical characterization and is accompanied by a detailed COA, including information on purity, identification, and handling. This ensures that every laboratory using AquigenBio's materials can do so with full confidence in the reliability of their analytical results.

Why Choose AquigenBio's Impurity Standards?
Pharmacopoeial alignment - Standards are prepared in accordance with EP monograph specifications
High-purity materials - Each batch is carefully synthesized and purified under controlled conditions
Traceable documentation - Includes COA, SDS, and batch-level data
Fast availability - Ready-to-ship inventory to meet urgent laboratory needs
Technical support - Scientific assistance available for method development and troubleshooting

AquigenBio works closely with research and development teams, analytical scientists, and regulatory affairs professionals to deliver impurity standards that facilitate smoother development cycles and greater confidence in analytical data.

Applications Across the Drug Lifecycle
These impurity standards are valuable at every stage of the pharmaceutical product lifecycle:
Preclinical and formulation development - For method validation and stress testing

Process optimization - To monitor potential synthetic by-products
Quality control - For batch release and routine QC
Stability testing - To track degradation over time
Regulatory submission - To support impurity specification in product dossiers

Their robust characterization and pharmacopeial compliance make them suitable for both R&D and GMP environments.

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 AquigenBio
AquigenBio is a trusted provider of pharmaceutical reference standards, specializing in impurity standards, working standards, and metabolite reference materials. With a commitment to scientific rigor and regulatory alignment, the company supports laboratories worldwide in producing safe, effective, and high-quality medicines.

This release was published on openPR.