BX LAB QUALITY & COMPLIANCE
Science-driven quality systems from development to project delivery
BX Lab works within an enterprise network that combines process development, analytical control, manufacturing support and certified management systems. Quality requirements are defined around the named material, legal entity, manufacturing site and customer specification.
Quality policy
Our quality approach is science-driven and customer-focused, covering the lifecycle from route and process design through raw-material control, manufacturing execution, analytical review and project-specific release. Specifications and analytical packages are aligned to the intended research use and the applicable supply site.
1. R&D and process design control
Technical risk assessment supports route selection, process robustness, impurity understanding and scale-up readiness.
2. Raw-material and supply-chain control
Supplier qualification, incoming-material review and defined specifications support consistent process inputs.
3. Manufacturing process control
Critical process parameters, intermediate checks and analytical feedback are used to keep project execution within agreed limits.
4. Release and stability assurance
Identity, purity, impurity profile, storage and stability-related attributes are reviewed according to the agreed material and project scope.
Certifications & compliance documents
The documents below are issued to named legal entities in the same enterprise network. Download individual certificate PDFs or use the complete supplier-qualification package. Certificate scope and validity should be verified during supplier qualification and project contracting.
Download complete certificate package (PDF)
ISO 9001:2015 Quality Management System
Certificate holder: Chongqing Xingcan Pharmaceutical Technology Co., Ltd.
Certificate no.: HIC232453
Validity: Valid through October 24, 2026
R&D and sales of chemical raw materials, including pharmaceutical intermediates, chemical reagents and catalysts, within the certificate scope.
ISO 14001:2015 Environmental Management System
Certificate holder: Chongqing Xingcan Pharmaceutical Technology Co., Ltd.
Certificate no.: HIC250417
Validity: Valid through April 16, 2028
Environmental management for the certified R&D and sales scope.
ISO 45001:2018 Occupational Health & Safety Management System
Certificate holder: Chongqing Xingcan Pharmaceutical Technology Co., Ltd.
Certificate no.: HIC250418
Validity: Valid through April 16, 2028
Occupational health and safety management for the certified R&D and sales scope.
ISO 9001:2015 Quality Management System
Certificate holder: Weifang Runzhong Fine Chemicals Co., Ltd.
Certificate no.: 03823Q510817R2S
Validity: Valid through October 26, 2026
Production and sales of the orthoester products named in the certificate.
ISO 14001:2015 Environmental Management System
Certificate holder: Weifang Runzhong Fine Chemicals Co., Ltd.
Certificate no.: 03823E510818R2S
Validity: Valid through October 26, 2026
Environmental management activities for the production and sales scope named in the certificate.
ISO 45001:2018 Occupational Health & Safety Management System
Certificate holder: Weifang Runzhong Fine Chemicals Co., Ltd.
Certificate no.: 03823S510819R2S
Validity: Valid through October 26, 2026
Occupational health and safety management activities for the production and sales scope named in the certificate.
AAA Enterprise Credit Grade
Certificate holder: Chongqing Xingcan Pharmaceutical Technology Co., Ltd.
Certificate no.: TXXY235103
Validity: Valid through October 15, 2026
Enterprise credit-grade certificate subject to annual review during its validity period.
Drug Production License
Certificate holder: Chongqing Langtian Pharmaceutical Co., Ltd.
Certificate no.: 渝20170136
Validity: Valid through August 30, 2027
Drug-production authorization for the named certificate holder and licensed site; this does not change the non-GMP status of BX Lab catalog materials.
Environment, health & safety
Environmental and occupational-health-and-safety management are integrated into process planning and site operations. For scale-up work, project review may include reaction hazard assessment, thermal-risk evaluation, controlled operating parameters, waste planning and site-specific EHS requirements.
Process safety
Hazard review, temperature and addition control, reaction monitoring and scale-appropriate risk assessment support safe process transfer.
Environmental responsibility
Solvent use, waste streams and operating controls are reviewed within the applicable site-management system.
Occupational health
Training, operating procedures, exposure controls and emergency preparedness support personnel protection.
Quality documentation available by project
| Product specification | Current identity, purity, form, storage and project-specific acceptance criteria. |
|---|---|
| Certificate of Analysis | Lot-specific results against the agreed specification for qualified orders. |
| Analytical support | HPLC or UPLC, MS, NMR and other fit-for-purpose data according to material and project scope. |
| Supplier qualification | Applicable legal entity, site and certificate information reviewed for the requested work. |
Important scope statement. A management-system certificate or drug-production license held by an affiliated entity does not by itself make a BX Lab catalog material GMP. Products described on this website are supplied for research use and are non-GMP.