group namePharmaceutical Excipients&APIS
Min Order1 piece
payment methodL/C, D/A, Western Union, T/T, Paypal
update timeMon, 23 Dec 2019 17:12:15 GMT
Appearance white crystalline powder
Min Order1 piece
CERTIFICATEOF ANALYSIS
Name: Tetracaine HCL BatchNumber: 20191108
Batch Size: 88kg Packing Size: 25kg/drum
Certificate No.:20191108 MFG Date: November 8, 2019
Date of Release: November 10, 2019 Expiry Date: November 7, 2020
ANALYSIS AS PER EP Standard.
Items of Test | Specifications | Result of Test |
Appearance | White to almost white,slightly hygroscopic,crystalline powder | white,slightly hygroscopic,crystalline powder |
Solubility | Freely soluble in water, soluble in ethanol(96%) | Conforms |
IR | Spectrum of the sample should conform with that of reference |
Conforms |
Identification | Conforms to standard | Conforms |
Chloride | Conforms to standard | Conforms |
Appearance of solution | Solution should be clear and colourless | Clear and colourless |
Ph value | 4.5-6.5 | 5.62 |
Melting point | About 148℃ | Conforms |
Heavy metal | ≤10ppm | Conforms |
Sulphated ash | ≤0.1% | 0.04% |
Loss on drying | ≤1.0% | 0.04% |
Assay | 99.0%-101.0% | 99.86% |
4-aminobenzoic acid | ≤0.05% | Not detected |
4-(butylamino) benzoic acid | ≤0.10% | 0.03% |
Methyl 4-(butylamino) benzoate | ≤0.10% | Not detected |
Any other unspeicified impurity | ≤0.10% | 0.06% |
Total impurities | ≤0.50% | 0.16% |
Conclusion: it conforms tothe standard EP.
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