FDA Ropivacaine HCl API USP Ropivacaine Hydrochloride CAS 132112-35-7

Minimum Order Quantity :	1 kg	Packaging Details :	20kg in a fiber drum
Delivery Time :	60 days	Payment Terms :	T/T, L/C
Supply Ability :	500 kg per year

Place of Origin:	China	Brand Name:	LIBANG
Certification:	US FDA Approval

Detail Information
Quality Specification:	USP	Dossier:	DMF Available
Certificate:	FDA Approval In 2014	Pack:	Allumium Foil Bag And Drum
Storage:	At Room Temperature	Min Qty:	1kg
High Light:	FDA Ropivacaine HCl API , Ropivacaine HCl API USP , Ropivacaine Hydrochloride CAS 132112-35-7

Product Description

Product Name:	Ropivacaine Hydrochloride
Manufacturer:	Xian Libang Pharmaceutical Co., Ltd.

Adverse Effects: This material may cause numbness on contact. Adverse effects following injection may include dizziness, nausea, back pain, fever, headache, pain, burning or prickling sensation, and vomiting. Possible allergic reaction to material if inhaled, ingested or in contact with skin.

Overdose Effects: Overdose of ropivacaine by injection may cause blue lips or skin, dizziness, and seizures.

Acute: Possible eye, skin, gastrointestinal and/or respiratory tract irritation.

Chronic: Possible hypersensitization.

Medical Conditions Aggravated by Exposure: Hypersensitivity to material and impaired cardiovascular or liver function.

Cross Sensitivity: Persons sensitive to other amide-type local anesthetics may be sensitive to this material also.

Target Organs: Nervous system, cardiovascular system

TEST		SPECIFICATION		RESULT
Appearance		White crystalline powder, No visible evidence of contamination by foreign matter		Conform
Solubility		Soluble in water		Conform
Identification	Identification A	IR spectrum corresponds to the IR spectrum of the reference standard		Conform
	Identification B	Positively responds to the test for Chlorides		Conform
Color		Absorption at 405nm not more than 0.030		0.0086
		Absorption at 436nm not more than 0.025		0.0081
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.		Conform
PH		4.5 to 6.0		5.14
Related Compounds		Bupivacaine	NMT 0.2%	＜LOD
		Individual unspecified impurity	NMT 0.05%	0.029%
		Total impurities	NMT 0.5%	0.03%
Water		5.0% to 6.0%		5.18%
Heavy Metals		NMT 0.001%		Conform
Residue on Ignition		NMT 0.1%		0.07%
Ionizable Chlorine		10.9%to11.8% calculated on the anhydrous basis		11.4%
Limit of Ropivacaine Related compound A		NMT 0.001%		＜LOD

Enantiomeric purity (Related Compound B)	NMT 0.5%		＜LOD
Residual solvents	Methylisobutyl Ketone	NMT 1000ppm	＜LOD
	Toluene	NMT 890ppm	＜LOD
	Acetone	NMT 1000ppm	213ppm
	Benzene	NMT 2ppm	＜LOD
	n-Propyl bromide	NMT 1.8ppm	＜LOD
	Ethanol	NMT 5000ppm	＜LOD
Bacterial Endotoxins	NMT0.04 EU/mg		＜0.04EU/mg
Total aerobic bacteria	NMT 100 CFU/g		＜10cfu/g
Assay	98.5% to 101.0% calculated on the anhydrous basis		100.2%

Tag:

Diatrizoic Acid(15)

Fulvestrant(24)

Meglumine(11)

Melphalan(6)

Nicorandil(8)

Anesthetic Propofol(12)

Tranexamic Acid(11)

Tolperisone Hydrochloride(11)

Lecithin(10)

Lipid Emulsion(10)

Succinylcholine Chloride(10)

Other Anesthetic and Cardiovascular Series(43)

FDA Ropivacaine HCl API USP Ropivacaine Hydrochloride CAS 132112-35-7

FDA Ropivacaine HCl API

Ropivacaine HCl API USP

Ropivacaine Hydrochloride CAS 132112-35-7

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