Benzocaine
Item specifics
- Appearance
- white crystal
Review
Description
CERTIFICATE OF ANALYSIS
Product Name: Benzocaine Batch Number:20130812
Batch Size:
Certificate No.:20190812 Manu Date: AUGUST 12, 2019
Date of Release: AUGUST13, 2019 Expiry Date: AUGUST 11, 2021
ANALYSIS AS PER USP36
Items of Test | Standard | Result of Test |
Appearance | White crystals or crystalline powder | White crystals |
Solubility | Freely soluble in alcohol,in chloroform and in ether,sparingly soluble in olive oil, very slightly soluble in water,dissolves in diluted acids | Conforms |
Melting point | 88 | 90.0 |
Melting range | Not more than | |
Identification | A. IR should comply with the reference standard spectrum B. UV should comply with the reference standard spectrum C. An orange red precipiate is performed |
Conforms
Conforms Conforms |
Loss on drying | Not more than 0.5% | 0.18% |
Readily carbonizable substances | The resolution has no more color than matching fluid A | Conforms |
Residue of ignition | Not more than 0.10% | 0.01% |
Heavy metal | Not more than 0.001% | Conforms |
Chloride | Should conform | Conforms |
Assay | 98.0%-102% | 99.98% |
Related substances(HPLC) | A. Any single known impurity ≤0.10% B. Any single unknown impurity ≤0.10% C. Total impurity ≤0.5% | Not detected 0.003% 0.005% |
Ordinary impurities (TLC) | ≤1.0% | Conforms |
Reaction | Should conformf | Conforms |
Total numbers of colony | Not more than 80cfu/g | Conforms |
Yeasts and Molds | Not more than 80cfu/g | Conforms |
Live mites and mite eggs | No live mite is detected | Not detected |
E.Coli | Negative | Conforms |
Staphylococcus aureus | Negative | Conforms |
Pseudomonas aeruginosa | Negative | Conforms |
Conclusion: It meets the standard USP36
