Raw Material Drug Lidocaine Hydrochloride for Pharmaceutical Applications

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Hebei Huachen Pharmaceutical Group Co., Ltd

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Lidocaine Hydrochloride
Powder
Medicine Grade
White Crystalline Powder
C14h22n2o. HCl
Pharmaceutical Grade
6108-05-0
Drum
15kg/drum
Cangzhou China
3004909030
Product Description
Company Profile

 

lidocaine hydrochloride 
preserve in well-closed containers. store at controlled room temperature.


Specification of Lidocaine Hydrochloride
Item Limit
Character White crystalline powder
Identification
  1. SPECTROSCOPIC IDENTIFICATION TESTS,Infrared Spectroscopy
  1. The retention time of the major peak of the Sample solution corresponds to that Standard solution , as obtained in the assay.
  1. IDENTIFICATION  TESTS- GENERAL, Chloride: Meets the requirements.
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  impuritiesLidocaine related compound HNot more than 0.10%
Ropivacaine related compound ANot 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 testWhere 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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