Ropivacaine HCl

Ropivacaine HCl

Ropivacaine HCl

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Product Details

Appearance   White crystalline powder, No visible evidence of contamination by foreign matter

Specific rotation        -210°to -255°at 365nm

Identification A          IR spectrum corresponds to the IR spectrum of the reference standard

Identification B          Positively responds to the test for Chloride

Clarity The Test solution is considered clear if its clarity is the same as that of water or if its opalescence is not more pronounced than that of Reference suspension 1.

Color   Absorption at 405nm not more than 0.030

            Absorption at 436nm not more than 0.025

Acidity value  4.5 to 6.0

Water 5.0% to 6.0%

Limit of related compound A           NMT 0.001%

Related substances

            Bupivacaine   NMT 0.2%

            Individual unknown impurity         NMT 0.1%

            Total impurities         NMT 0.5%

Enantiomeric purity NMT 0.5%

Heavy metals NMT 0.001%

Bacterial endotoxins NMT 5 EU/mg

Total aerobic bacteria           NMT 100 CFU/g

Assay  98.5% to 101.0%(on the anhydrous basis )
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