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Ropivacaine Hydrochloride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Ropivacaine Hydrochloride USP CAS No: 132112- 35- 7

Batch No: ROP/ 030313 A. R. No 13/ FP/ ROP/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification

Complies a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

Complies b) Chloride: Meets the requirements.

4. Related Substances

Individual Impurity Total Impurity

0.03%

0.17%

NMT 0.1%

NMT 0.5%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) - 234º Between - 210° to - 255°

6. pH 3.4 Between 4.5–6.0

7. Bacterial Endotoxins Test Complies Meets the requirements

8. Heavy Metals Complies NMT 10ppm

9. Water Content by KF 5.2% 5.0% –6.0% .

10. Residue On Ignition 0.06% NMT 0.1%

11. Assay 99.17% 98.5% –101.0%

Ropivacaine

Ropivacaine. png

Ropivacaine ball- and- stick. png

Systematic ( IUPAC) name

( S) - N- ( 2, 6- dimethylphenyl) -

1- propylpiperidine- 2- carboxamide

Clinical data

AHFS/ Drugs. com Consumer Drug Information

Pregnancy

category

AU: B1

Legal status

AU: Prescription Only ( S4)

Routes of

administration Parenteral

Pharmacokinetic data

Bioavailability 87% –98% ( epidural)

Metabolism Hepatic ( CYP1A2- mediated)

Biological half- life 1.6–6 hours ( varies with administration route)

Excretion Renal 86%

Identifiers

CAS Registry Number 84057- 95- 4 Yes

ATC code N01BB09

PubChem CID: 175805

IUPHAR/ BPS 7602

DrugBank DB00296 Yes

ChemSpider 153165 Yes

UNII 7IO5LYA57N Yes

KEGG D08490 Yes

ChEBI CHEBI: 8890 Yes

ChEMBL CHEMBL1077896 Yes

Chemical data

Formula C17H26N2O

Molecular mass 274.4 g/ mol


Company Contact:


  • Phone: 912406641875

  • Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India

  • Email: Email


Published date: September 14, 2015 -

  • Business Description: We, at SWAPNROOP, are committed to providing affordable Drugs &

    Pharmaceuticals of global quality standards to Pharma Companies all over

    the world. In our warehouse facilities, approved by FDA. we supply

    Pharmaceutical Finished products, Dental products and Active

    Pharmaceutical Ingredients.

    We, at SWAPNROOP, are committed to providing affordable Drugs & Pharmaceuticals of global quality standards to Pharma Companies all over the world. Our warehouse facilities is approved by FDA and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's) and Dental products, providing a wide range of quality and affordable products to a large number of pharmaceutical companies, reputed private and government/semi government organizations/ research centers as well as universities.

    We supply and market over 500 molecules and their combinations in multiple dosage forms, catering to patient needs in various therapies. These include Anti infectives, Cardiovascular, Pain management, Central Nervous System (CNS), Gastrointestinal, Respiratory, Dermatology, Orthopaedics, Nutritionals, Urology and Dental.

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