| Product Name | 4-CDC |
| Purity | 99.4% min |
| Application | For chemical research |
| Package | foil bag |
| Storage | Keep in cool, dry and ventilated place |
| Transportation | EMS,DHL,TNT,FEDEX,UPS |
| Supply Ability | 500 Kilogram/Month |
| Min Order | 10g |
| Payment Term | T/T,Western Union,MoneyGram,Other |
| Delivery Time | within 3 working days |
| Item | Specifications | Result |
| Appearance | White or almost white powder | Off white powder |
Indentification
|
HPLC:The retention time of principle peak obtained from
Test solution should conform with that obtained from
Standard solution, as test in Assay
| Conforms |
IR: Spectrum of Test sample should conform to that
of Caspofungin Acetate Reference Standard
| Conforms | |
| Specific Optical Rotation | -102.0°~108.0 ° | -105.3° |
| PH | 5.0~7.0 | 6.5 |
| Water | 10.0% | 7.5% |
| Solution color and clarity | Solution should be clear colorless | Conforms |
| Related substances I | Impurity A: NMT 0.10% | ND |
| Impurity B: NMT 0.10% | ND | |
| Impurity D: NMT 0.30% | 0.17% | |
| Impurity E: NMT 0.10% | ND | |
| Unspecified impurity F: NMT 0.10% | 0.03% | |
| Unspecified impurity G: NMT 0.10% | ND | |
| Pneumocandin B0: NMT 0.10% | ND | |
| Each of unspecified impurity : NMT 0.10% | 0.04% | |
| Total impurity: NMT 1.0% | 0.24% | |
| Related substances II | Impurity C: NMT 0.10% | 0.03% |
| Acetic acid | 9.0%~11.0%(calculated on anhydrous basis) | 10.1% |
| Heavy Metal as Pb | NMT 10ppm | Conforms |
| Item | Specifications | Analysis Results | Conclusion |
| Appearance | Light yellow solid | Light yellow solid | conform |
| HNMR | Comply with the structure | Comply with the structure |
Conform
|
| LC-MS | Comply with the structure | Comply with the structure |
Conform
|
| Purity | ≥95% |
99.1%(254nm)
99.4%(220nm)
|
Conform
Conform
|
| Melting point | N/A | N/A | N/A |
| TEST ITEM | Specification | TEST RESULT |
| Identification | positive reaction | comply |
| Loss on drying | MAX 0.5% | 0.18% |
| Residue on ignition | MAX 0.1% | 0.07% |
| Heavy metal | MAX10ppm | comply |
| Melting point | 117-120°C | 118-119°C |
| Clarity and degree of opalescence of liquids |
1%ethanol and chloroform
Solution
| comply |
| Particle size | 80-120mesh | comply |
| related substances | Max0.1% | comply |
| residual solvents: ethanol | Max 1000ppm | comply |
| total viable count | Max3000cfu/g | comply |
| yeast and moulds | Max300cfg/g | comply |
| e. coli | Absence/g | comply |
| salmonella | Absence/25g | comply |
| HPLC | ≥99.5% | 99.55% |
Items
|
Standard USP37
|
Results
| |||
Character
|
White or almost white crystalline powder
|
White crystalline powder
| |||
Identification:
|
Positive
|
Positive
| |||
Residue on ignition
|
≤0.5%
|
0.05%
| |||
Heavy metals
|
NMT 20ppm
|
4ppm
| |||
Sulphated ash
|
NMT 0.1%
|
0.04%
| |||
Loss on drying
|
NMT 0.5%
|
0.13%
| |||
Total impurities
|
NMT 1.5%
|
Conforms
| |||
Residual solvents
|
Methanol NMT 3000ppm
|
Conforms
| |||
Ethanol NMT 5000ppm
|
Conforms
| ||||
Ethyl acetate NMT 5000ppm
|
Conforms
| ||||
Assay(HPLC)
|
97%-103%
|
99.52%
|
