과학 서비스
Specialized impurity management, structural elucidation, and process risk assessment services designed for global regulatory compliance.
분석 및 구조
미지 불순물 대상
구조 규명
Comprehensive interpretation of spectroscopic data to determine the exact structure of unknown compounds.
Analytical 더 알아보기
불순물 분리
Isolation and purification of unknown impurities from drug substances to enable full characterization.
Purification 더 알아보기
COA 샘플 검토
Review our standard documentation and data integrity formats to ensure alignment with your quality needs.
Documentation 샘플 보기
안전 및 위험 평가
규제 타당성 입증
변이원성 (ICH M7)
In silico and expert review assessments for impurity mutagenic potential in compliance with ICH M7.
Toxicology 더 알아보기
니트로사민 조사
Root cause analysis and control strategy development specifically for nitrosamine risks.
Nitrosamines 더 알아보기
TD50 결정
Calculation and justification of TD50 values to establish acceptable intake limits for novel nitrosamines.
Calculations 더 알아보기
공정 및 제어
완화 전략
퍼지 계수 평가
Evaluate the capability of your manufacturing process to purge toxic impurities and justify control skipping.
Process 더 알아보기
니트로사민 실패 보고서
Scientific reporting for cases where synthesis or confirmation of a theoretical nitrosamine fails.
Reporting 더 알아보기
CEP 신청 결함
Consulting on the top 10 common deficiencies to avoid delays in your Certification of Suitability.
Regulatory 더 알아보기
맞춤형 지원
Tailored projects
