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.
Third-party testing for sex hormone detection is essential for ensuring product quality, compliance, and consistency in industries ranging from pharmaceuticals to biotechnology. Clients seeking partner laboratories often begin by evaluating the scope of services offered to determine alignment with their specific testing needs. Our laboratory, accredited by CNAS and CMA, specializes in the analysis of sex hormones across various matrices, supporting clients with robust methodologies and standardized protocols. The following sections outline the testing scope, parameters, and data analysis capabilities for sex hormone detection services.
Testing Scope
Our sex hormone detection services cover a wide range of products, materials, and application scenarios relevant to the life sciences industry. Applicable products include pharmaceutical formulations, biologic drugs, dietary supplements, and environmental samples. Materials analyzed encompass liquids, solids, and semi-solids, with support for custom matrices as needed. We test for various grades of sex hormones, including but not limited to estrogen (E1, E2, E3), testosterone, and progesterone, tailored to client specifications. Application scenarios include drug development, quality control, and research studies. Commonly referenced standards for these tests include ASTM E1607, ISO 17378, EN 16542, and GB/T 23387, ensuring compliance with international requirements.
Testing Items and Parameters
Testing items for sex hormone detection include both individual hormone quantification and panel analysis. Typical parameters analyzed are outlined in the table below:
| Hormone | Typical Detection Limit (ng/mL) | Graded Limit Requirement (%) |
|---|---|---|
| Estrogen (E1) | 0.1 | ±5 |
| Estrogen (E2) | 0.5 | ±4 |
| Estrogen (E3) | 0.2 | ±6 |
| Testosterone | 0.3 | ±3 |
| Progesterone | 0.4 | ±5 |
Graded limit requirements ensure accuracy within specified tolerance levels, with adjustments made for high-purity or low-concentration samples as needed. Additional parameters, such as recovery rates and inter-assay variability, are also provided upon request to support comprehensive quality assessment.
Data and Variation Analysis
Parallel-sample and batch-to-batch variation are rigorously assessed to ensure consistency and reliability in results. For parallel-sample analysis, relative deviation between replicate samples is calculated using the formula: (Sample Mean / Reference Mean) × 100. Typical acceptance windows for relative deviation are within ±10% for standard samples and ±15% for low-concentration samples. Batch-to-batch variation is evaluated by comparing results from consecutive batches of identical samples, with variation coefficients (CV) reported as percentages. Acceptance criteria for CV are generally set at ≤15% for most hormones, though stricter limits may apply based on regulatory guidelines.
Statistical methods, including ANOVA and linear regression, are employed to analyze data and validate method performance. All variation data is documented in reports, accompanied by acceptance statements confirming compliance with predefined thresholds. This approach ensures that clients receive results with validated precision and reliability, supporting decision-making in regulatory submissions and quality control processes.
To proceed with testing, please confirm your required testing items and sample quantity. We will revert with a formal quotation and expected schedule tailored to your specific needs.