| Powder: | Yes |
|---|---|
| Certification: | GMP, HSE, ISO 9001, USP, BP |
| Suitable for: | Elderly, Children, Adult |
| State: | Solid |
| Purity: | >99% |
| Purity Degree: | 99% |
| Customization: |
|---|
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| Items |
Standard |
Result |
| APPEARANCE | Odorless ,white powder | Odorless ,white powder |
| IDENTIFICATION | The IR spectrum of Potassium Bromide preparation of the sample exhibits maxima at the same wavelengths as that of a simailar preparation of in-house reference standard | Conforms |
| The retention times of main peak in the Chromatogram of assay preparation corresponds tothat in the Chromatogarmof standard preparationas obtain in the assay | Conforms | |
| WATER CONTENT | ≤4.0% | 2.7% |
| HEAVY METALS | ≤20ppm | Conforms |
| TOTAL ISOMERS OF TACROLIMUS | ≤1.5% | 0.85% |
| LARGEST INDIVIDUAL IMPURITY | ≤0.5% | 0.32% |
| TOTAL IMPURITIES | ≤1.0% | 0.64% |
| ASSAY | 98.0% ~ 102.0%, On the anhydrous basis (including isomers of Tacrolimus) | 99.2% |
| RESIDUAL ORGANIC SOLVENTS | Ethyl ethe ≤ 5000ppm | Not Detected |
| Methyl Tert-butyl ether ≤1000ppm | Not Detected | |
| Conclusion | Qualified | |
|
Items |
Standard |
Result |
|
Appearance |
White to off-white powder |
White powder |
|
Assay (W/W dry basis) |
≥98.0% |
99.16 % |
|
Residue on ignition |
<0.5% |
0.256% |
|
Water (w/w by KF) |
≤1.0% |
0.420% |
|
pH Value(1% aq.) |
5~9 |
7.28 |
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