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(R)-5-HydroxyMethyl Tolterodine 2-[(1R)-3-(dipropan-2-ylamino)-1-phenylpropyl]-4-(hydroxymethyl)phenol 207679-81-0
Name: | 3-[(1R)-3-[Bis(1-methylethyl)amino]-1-phenylpropyl]-4-hydroxybenzenemethanol |
Iterm: | Pharmaceutical intermediates |
CAS: | 207679-81-0 |
structure: | |
Package: | 25kg/drum |
purity: | 0.98% |
Capacity: | 1T/M |
Use: | Pharmaceutical intermediates |
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% |
<0.10% |
Total Impurity |
≤0.5% |
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 |
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