Ropivacaine Hydrochloride Hydrate

Ropivacaine hydrochloride hydrate was first approved by the U.S. Food and Drug Administration (FDA) on September 26, 1996, then approved by Pharmaceuticals and Medical Devices Agency of Japan (PMDA) in April 4, 2001. It was developed by AstraZeneca, then marketed as Naropin® by APP Pharmaceuticals, LLC. in the US and as Anapeine® by AstraZeneca in JP.

Ropivacaine is a local anaesthetic drug belonging to the amino amide group. It is indicated for the production of local or regional anesthesia for surgery and for acute pain management.

Naropin® is available as injection solution for intravenous use, containing 2, 5, 7.5 or 10 mg of Ropivacaine hydrochloride one mL. Common concentration is 7.5 mg/mL, and the maximum single dose is 200 mg.

General Information

Update Date:2016-03-24

Drug Name:
Ropivacaine Hydrochloride Hydrate
Research Code:
LEA-103; NA-001; (-)-LEA-103; 
Trade Name:
Naropin® / Anapeine®
MOA:
Sodium channels blockers
Indication:
Anaesthetic
Status:
Approved
Company:
AstraZeneca (Originator) , Fresenius Kabi
Sales:
ATC Code:
N01BB09
Approved Countries or Area

Update Date:2015-07-29

Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
1996-09-26 First approval Naropin Anaesthetic Injection 2 mg/ml; 5 mg/ml; 7.5 mg/ml; 10 mg/ml APP Pharmaceuticals
Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2001-04-04 First approval Anapeine Anaesthetic Injection 2 mg/ml; 7.5 mg/ml; 10 mg/ml AstraZeneca
Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2010-02-11 Marketing approval 耐乐品/Naropin Anaesthetic Injection 20 mg/10 ml;100 mg/10 ml; 75 mg/10 ml; 50 mg/10 ml AstraZeneca
2010-02-03 Marketing approval 耐乐品/Naropin Anaesthetic Injection 2 mg/mL AstraZeneca
Chemical Structure

Update Date:2015-08-27

Molecular Weight 328.88
Formula C17H26N2O • HCl • H2O
CAS No. 84057-95-4 (Ropivacaine);
132112-35-7 (Ropivacaine HCl Monohydrate);
Chemical Name S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate
Ropivacaine (Free Acid/Base)Parameters:
MW HD HA FRB* PSA* cLogP*
274.40 1 3 4 32.3 2.802±0.380
*:Calculated by ACD/Labs software V11.02.
Related Patents

Update Date:2016-02-03

Synthesis & Impurities

Update Date:2016-01-15


1. US2799679A.

2. US4870086A.


1. WO8500599A1.



1. CN104003930A.

Impurity database is being updated!