Customization: | Available |
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Type: | Lidocaine Hydrochloride |
Appearance: | Powder |
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Audited by an independent third-party inspection agency
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. |