Reasons for choosing our testing services
ZHONGXI Testing has obtained inspection qualification certifications from multiple countries and regions worldwide. We possess a senior testing team and advanced testing methods, providing independent, impartial, and professional third-party verification services for global carbon projects.
Internationally recognized authority
Certified by multiple international standards such as CNAS, VCS, and GS, with reports universally applicable worldwide.
Global service capability
Covering 140+ countries and regions, it supports on-site detection and remote verification in multiple languages.
Professional experimental methods
Adopt standard experimental methods to ensure accurate and reliable data.
For procurement and quality teams seeking third-party testing services, a well-defined scope of testing is essential. It minimizes ambiguity, accelerates timelines, and ensures the laboratory focuses on the most critical requirements. Our endocrine testing services are designed to meet the needs of international clients across various industries, providing reliable data to support quality assurance, regulatory compliance, and product development. By clearly outlining the applicable products, materials, grades, and standards, we facilitate efficient collaboration and timely results.
Testing Scope
The testing scope for endocrine-related services encompasses a wide range of products and materials, including pharmaceuticals, biopharmaceuticals, medical devices, personal care products, and environmental samples. These materials may involve endocrine active compounds (EACs), such as hormones, hormone analogs, and other chemical entities that interact with endocrine systems. The grades of materials tested vary from raw ingredients to finished products, depending on client requirements. Application scenarios include regulatory submission, product safety assessment, and research and development purposes.
Commonly referenced standards for endocrine testing include ASTM, ISO, EN, and GB specifications, depending on the region and regulatory framework. For instance, ASTM standards may cover methods for detecting endocrine disruptors in water samples, while ISO standards might focus on hormone analysis in pharmaceuticals. EN standards often address endocrine-related testing in consumer products, and GB standards are relevant for Chinese market requirements. These standards ensure consistency and comparability across testing methodologies.
Testing Items and Parameters
The testing items and parameters for endocrine testing are designed to assess the presence, concentration, and potential impact of endocrine active substances. Typical test items include hormone analysis, estrogenic activity assays, and androgenic activity evaluations. The parameters for these tests are carefully defined to meet regulatory and client-specific requirements.
Below is a table outlining typical parameters for hormone analysis in pharmaceutical samples:
| Test Item | Typical Parameters | Graded Limit Requirements |
|---|---|---|
| Estrogenicity | EC50 (Effective Concentration for 50% response) | < 0.1 ng/L for drinking water, < 50 ng/g for pharmaceuticals |
| Androgenicity | TC50 (Test Compound 50% response) | < 0.5 ng/L for drinking water, < 20 ng/g for pharmaceuticals |
| Thyroid Activity | TTC50 (Thyroid-Blocking Activity 50% response) | < 1 ng/L for drinking water, < 10 ng/g for pharmaceuticals |
Additional parameters may include cortisol levels, testosterone concentrations, and other relevant biomarkers, depending on the specific application and regulatory requirements. Graded limit requirements are set based on international guidelines and client specifications, ensuring compliance with market entry standards.
Data and Variation Analysis
Assessment of parallel-sample and batch-to-batch variation is critical in endocrine testing to ensure data reliability and consistency. Parallel-sample variation is evaluated by calculating the relative deviation between duplicate or triplicate samples analyzed under identical conditions. Typically, relative deviations for hormone assays are maintained within 5-10% for high-quality samples, ensuring method precision.
Batch-to-batch variation is analyzed by comparing results from consecutive sample batches processed using the same testing methodology. Acceptance windows for batch-to-batch variation are established based on historical performance data, with typical limits set at 15-20% relative deviation for routine samples. These variations are reported alongside the test results, providing clients with transparency into method performance and data quality.
The laboratory employs rigorous quality control measures, including positive and negative controls, method validation, and proficiency testing, to minimize variability and ensure robust data integrity. Data and variation analysis reports are provided as part of the testing documentation, supporting compliance with regulatory and industry standards.
Send us your testing item list and sample details, and our engineers will confirm the applicable items and turnaround within one working day.