China FDA Approved Postmenopausal Women with Osteoporosis Teriparatide Acetate Parathyroid Hormone Powder, Find details about China Teriparatide Acetate, Parathyroid Hormone from FDA Approved Postmenopausal Women with Osteoporosis Teriparatide Acetate Parathyroid Hormone Powder
Item | Standard | Test Results |
Identification | A.H-NMR:Comply with the structure | Complies |
B.LC-MS:Comply with the structure | Complies | |
C.The IR spectrum of sample should be identical with that of reference standard; | Complies | |
D.HPLC-ESI-MS The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. | Complies | |
Crystallinity | meets the requirements. | Complies |
Loss on drying | ≤2.0% | 0.19% |
Heavy metals | ≤10 ppm | <10ppm |
Water | ≤1.0% | 0.1% |
Sulphated ash | ≤0.5%, determined on 1.0 g. | 0.009% |
Related substances | Unspecified impurities: for each impurity | <0.10% |
Total Impurity | 0.18% | |
Purity | ≥99.0% | 99.7% |
Assay | 99.0%~101.0% (anhydrous substance). | 99.8% |
Microbiological Analysis | ||
Total plate count | ≤1000cfu/g | Complies |
Yeast and Moulds | ≤100cfu/g | Complies |
E. Coli. | Absent | Negative |
Salmonella | Absent | Negative |
S.aureus | Absent | Negative |
Storage | Preserve in well-closed, light-resistant and airtight containers. | Complies |