| Customization: | Available |
|---|---|
| Type: | Lidocaine Hydrochloride |
| Appearance: | Powder |
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preserve in well-closed containers. store at controlled room temperature.| Item | Limit | |
| Character | White crystalline powder | |
| Identification |
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| Residue on ignition | Not more than 0.1% | |
| Sulfate | The turbidity does not exceed that produced by 0.10mL of 0.020N sulfuric acid (not more than 0.1%) | |
| Organic impurities | Lidocaine related compound H | Not more than 0.10% |
| Ropivacaine related compound A | Not more than 0.01% | |
| Any individual unspecified impurity | Not more than 0.10% | |
| Total impurities | Not more than 0.5% | |
| Water determination | 5.0%-7.0% | |
| Sterility tests | Where the label states that Lidocaine Hydrochloride is sterile, it meets the requirements. | |
| Bacterial endotoxins test | Where the label states that Lidocaine Hydrochloride is sterile or must be subjected dosage forms, it contains NOT MORE THAN 1.1USP Endotoxin Units/mg of lidocaine hydrochloride. | |
| Assay | 97.5%-102.5% on the anhydrous basis. | |
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