Analysis & Method Validation
End-to-end services covering the full lifecycle from analytical method development to routine testing applications. STD holds dual accreditations — CNAS 17025 testing laboratory and CNAS 17034 reference-material producer — and delivers one-stop physicochemical testing, instrumental analysis, analytical method development and full method validation. Every batch ships with a complete COA, with test data meeting the CNAS quality system and traceable to NIM secondary reference materials, ready for drug submission and GMP inspection.
Analytical Method Development & Validation Dual CNASSystem Control
Contact Us检测报告国际互认：STD持有CNAS 17025检测实验室与CNAS 17034标准物质生产者双项认可资质，检测数据符合CNAS质量体系要求，量值可溯源至中检院国家二级标准物质。每批次产品随附完整COA（含全套检测图谱及不确定度评估），数据可直接用于CDE/FDA/EMA等国内外药品注册申报，满足ICH Q2、Q3等法规对数据完整性的要求。
标准品研发与检测一体化同源：试验所用对照品均为STD自主合规生产，依托CNAS 17025/17034双认可体系搭建完整计量溯源链条，检测全流程无需外购外部标准品辅助试验，溯源资料完整可查。
能力验证持续合格：STD常态化参与CNAS及权威机构开展的能力验证（PT）与比对试验，近三年参与XX次，通过率100%（或具体数据），持续证实实验室检测数据精准可靠，保障全流程检测能力稳定合规。
全流程质量受控：从样品标定、检测执行至COA报告放行，全过程遵循CNAS 17025/17034双质量体系管理，全环节原始记录完整、量值可完整追溯，体系设计匹配药企GMP审计与药政核查全部数据合规要求。
Physicochemical Testing
Physicochemical Testing
Physicochemical testing is the foundational pillar of pharmaceutical quality control. It focuses on the determination of physical constants and verification of chemical characteristics, covering all statutory pharmacopoeial tests such as description and limit tests under the monographs of major pharmacopoeias. It is the essential basis for batch release and regulatory compliance review.
STD's physicochemical testing service covers routine pharmacopoeial tests (description, solubility, melting point, pH, optical rotation, limit tests, etc.) under the monographs of the Chinese Pharmacopoeia (ChP), the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP). All experimental operations, data recording and result adjudication strictly follow the CNAS-CL01 accreditation criteria, establishing a fully traceable quality control system. Each batch of test data is delivered with complete raw records, traceable to NIM secondary reference materials, and can be directly used for production release and regulatory submission.
Compared with routine testing, pharmacopoeial physicochemical tests impose stringent requirements on operational standardization, boundary-result adjudication and abnormal-condition handling. Drawing on years of hands-on pharmaceutical-testing experience, our team accurately executes all categories of pharmacopoeial standards and handles boundary data and experimental exceptions in a compliant manner, providing reliable data support for quality control, batch release and regulatory submission.
Main Test Items & Pharmacopoeial Basis
Testing Capability Overview
熔点、比旋度、折光率、密度、黏度
颜色、状态、溶解度
颜色反应、沉淀反应、红外光谱鉴别
氯化物、硫酸盐、铁盐、重金属、砷盐
干燥失重、炽灼残渣、pH值
晶型、粒径分布、松密度、堆密度
Use Cases
01 原料药进厂检验
每批原料药到货后，按药典标准进行外观、熔点/比旋度、溶解度、干燥失重、炽灼残渣、pH值等主要理化项目检测，确认符合规格后方可入库使用。
02 制剂成品放行
制剂成品的性状、鉴别（化学反应）、pH值、干燥失重等理化项目是放行检测的必检项，需在放行前完成全部检测并获得合格结论。
03 稳定性考察
在长期和加速稳定性研究中，理化指标（外观、pH值、干燥失重等）是各时间点的必检项，用于监测药品在储存期间的质量变化趋势。
04 辅料质量评价
药用辅料同样需按药典标准进行理化检测，特别是功能性指标（如黏度、粒径分布）直接影响制剂工艺和产品性能。
05 药政注册申报
新药注册申报资料中需提供原料药和制剂的全套理化检测数据，STD可提供符合数据完整性要求的检测数据及原始记录，支持申报资料整理。
06 异常样品排查
当出现含量偏低、溶出异常等问题时，通过理化检测（外观变化、熔点偏移、pH值变化等）快速排查原料药是否存在质量问题。