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Butorphanol Tartrate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Butorphanol Tartrate USP CAS No:

Batch No: BUT/ 030313 A. R. No 13/ FP/ BUT/ 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) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

4. Related Substances

Total Impurity

0.9%

NMT 2.0%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) - 62º Between - 60° to - 66°

6. Water Content by KF 1.2% NMT 2.0%

7. Heavy Metals Complies NMT 30 ppm

8. Residue On Ignition 0.03% NMT 0.1%

9. Assay HPLC 99.57% 98.0 to 102.0%

. .

Butorphanol

Butorphanol2DCSDT. svg

Butorphanol3DanJ. gif

Systematic ( IUPAC) name

( 4bR, 8aR, 9S) - 11- ( cyclobutylmethyl) - 6, 7, 8, 8a, 9, 10- hexahydro- 5H- 9, 4b- ( epiminoethano) phenanthrene- 3, 8a- diol

Clinical data

Trade names Stadol

AHFS/ Drugs. com Micromedex Detailed Consumer Information

MedlinePlus a682667

Pregnancy

category

C/ D ( United States)

Legal status

AU: Controlled ( S8)

US: Schedule IV

Routes of

administration IV, intranasal, oral

Pharmacokinetic data

Bioavailability Nasal: 60- 70%

Metabolism Hepatic hydroxylated & glucuronidated

Biological half- life 4- 7 hours

Excretion Renal, 75%

Biliary, 11- 14%

Fecal, 15%

Identifiers

CAS Registry Number 42408- 82- 2

ATC code N02AF01 QR05DA90

PubChem CID: 5361092

IUPHAR/ BPS 7591

DrugBank DB00611 Yes

ChemSpider 16735714 Yes

UNII QV897JC36D Yes

KEGG D00837

ChEBI CHEBI: 3242 Yes

ChEMBL CHEMBL33986 Yes

Chemical data

Formula C21H29NO2

Molecular mass 327.473 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 5, 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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