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Raw Material Drug Used in Medicine Lidocaine Hydrochloride

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Hebei Huachen Pharmaceutical Group Co., Ltd

Audited Supplier 2 years

Profile Certified by SGS/BV

Hebei, China
Grace Wei (Ms.)
Minister of Foreign trade

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Model NO.:

none

Type:

Lidocaine Hydrochloride

Appearance:

Powder

Grade Standard:

Medicine Grade

Characte:

White Crystalline Powder

Molecular Formula:

C14h22n2o. HCl

Grade:

Pharmaceutical Grade

CAS No.:

6108-05-0

Transport Package:

Drum

Specification:

15kg/drum

Origin:

Cangzhou China

HS Code:

3004909030

Product Description

lidocaine hydrochloride

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

Specification of Lidocaine Hydrochloride

Item		Limit
Character		White crystalline powder
Identification		SPECTROSCOPIC IDENTIFICATION TESTS,Infrared Spectroscopy
		The retention time of the major peak of the Sample solution corresponds to that Standard solution , as obtained in the assay.
		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 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.