QC Release Analysis

Critical analysis for quality and safety standards

For raw materials, APIs, finished products, and stability studies

Extensive tests aligned with international pharmacopeial standards

QNTM Labs provides comprehensive QC Release Analysis services, critical for ensuring that raw materials, APIs (Active Pharmaceutical Ingredients), and finished products meet the stringent quality and safety standards required by regulatory bodies.

Our advanced laboratory facilities perform extensive testing in alignment with international pharmacopeial standards.

Raw Materials

Identity Verification: Confirming the chemical identity of raw materials to ensure they match specifications for quality and purity.

Contaminant Testing: Screening for unwanted chemicals, heavy metals, and other impurities that could compromise product safety. 

APIs

Potency Testing: Quantifying the active ingredients to confirm their effectiveness and ensure dosage accuracy.

Purity Analysis: Ensuring the API is free from unwanted chemicals and meets the purity specifications.

Impurity Profile: Identifying and quantifying impurities and degradation products that may arise during manufacturing and storage. 

Release testing

Release Testing: Performing comprehensive tests on each production batch to ensure that finished products comply with the quality standards and specifications.

Dissolution Profiles: Assessing how quickly and efficiently the drug releases into the body under simulated physiological conditions.

Stability Studies

Shelf-Life Determination: Conducting long term and accelerated stability studies to predict product shelf life and ensure long-term quality and safety.

Photostability Testing: Evaluating the impact of light exposure on the product to ensure that it remains stable and effective throughout its intended shelf life.

Environmental Stress Testing: Simulating various environmental conditions to understand potential effects on product integrity and performance.

Compliance and Documentation

Regulatory Adherence: Ensuring all testing and documentation comply with regulatory standards, supporting successful audits and product registrations.

Detailed Reporting: Offering thorough reports that cover test methodologies, results, and compliance assessments to facilitate decision-making.