Test Items                        Specification                         Result

Appearance                  Yellow Crystalline Powder                 Complies

Identification(HPLC)           Meets the requirements                   Complies

Melting point                      60-62âÂ?Â?                           61.8âÂ?Â?

Solubility                   Clear and Pale Yellow                Complies

Residue on Ignition              ≤0.1%                            0.03%

Heavy Metals                     ≤10ppm                          <10ppm

Chloride                         ≤0.1%                           <0.07%

Loss on drying                   ≤0.2%                            0.05%

Assay                            99-101%                           99.4%

Specific Optical Rotation       -1°--+1°                         Complies

 

Related Substance by HPLC

Single Impurity                    ≤0.1%                            0.03%

6,8-Epitrithiooctanoic acid      ≤0.1%                            0.02%

Total Impurities                 ≤0.5%                            0.05%

Polymers                         ≤2%                              <2%

Residual Solvents by GC

Toluene                          ≤30ppm                           <20ppm

Ethyl Acetate                    ≤250ppm                          Negative

Cyclohexane                      ≤0.2%                            0.08%

 

Microbiology

Total Aerobic Counts             ≤1000cfu/g                       <100cfu/g

Mould&Yeast                      ≤100cfu/g                        <10cfu/g

E.coli                           Negative                           Negative

Salmonellas                      Negative                           Negative