Amphastar  Nanjing

• Medicine Analysis

          1.One-stop service for analysis / stability / CMC declared for IND / CTA, NDA / MAA & ANDA ;

          2. Method development and method validation;

          3. Analysis test and release;

          4. Stability study;

          5. Large-scale separation;

          6.CMC filing documents .

• Biopharmaceutical Services

          1.Analytical method development, certification and validation;

          2. Biological analysis test;

          3. Analysis Services and Raw Material Inspection;

          4. Forced degradation and stability studies.

• Analysis Services

          1.Early analysis development and quality control;

          2. Post-analysis R & D and Product Support;

          3. Stability study;

          4. New drug declaration CMC service;

          5. Isolation and identification of impurities;

          6. Physical and chemical characterization and other services.

• Preclinical services

          1.General Toxicology Services;

          2. GLP Bioanalysis Services;

          3. Discovery Bioanalysis Services;

          4. Pharmaceutical and GLP Analytical Chemistry Services.

• Bioanalysis Services

          1. Characterization Analysis Service;

          2. Purity / Content Analysis Services;

          3. Special services;

          4.Pharmaceutical and GLP Analytical Chemistry Services.