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Naltrexone Hydrochloride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Naltrexone Hydrochloride USP CAS No: 16676- 29- 2.

Batch No: NAL/ 030313 A. R. No 13/ FP/ NAL/ 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 By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

4. Related Substances

Individual Impurity Total Impurity

0.18%

0.75%

NMT 0.5%

NMT 1.5%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) - 189º Between - 187° and - 197°

6. Assay HPLC 99.37% 98.0% –102.0%

7. Content Of Chloride 9.37% 9.20% –9.58%

.

Naloxone. svg

Naloxone- 3D- balls. png

Systematic ( IUPAC) name

( 1S, 5R, 13R, 17S) - 10, 17- dihydroxy- 4- ( prop- 2- en- 1- yl) - 12- oxa- 4- azapentacyclo [ ] octadeca- 7( 18) , 8, 10- trien- 14- one

Clinical data

Trade names Narcan, Evzio

AHFS/ Drugs. com monograph

Pregnancy

category

AU: B1

US: C[ 1]

Legal status

AU: Prescription Only ( S4)

UK: Prescription- only ( POM)

Routes of

administration Endotracheal, nasally, IV, IM

Pharmacokinetic data

Bioavailability 2% ( Oral, 90% absorption but high first- pass metabolism)

Metabolism Liver

Onset of action 2 min ( IV) , 5 min ( IM) [ 1]

Biological half- life 1- 1.5 h

Duration of action 30 to 60 min[ 1]

Excretion Urine, Biliary

Identifiers

CAS Registry Number 465- 65- 6 Yes

ATC code V03AB15

PubChem CID: 5284596

IUPHAR/ BPS 1638

DrugBank DB01183 Yes

ChemSpider 4447644 Yes

UNII 36B82AMQ7N Yes

KEGG D08249 Yes

ChEBI CHEBI: 7459

ChEMBL CHEMBL80 Yes

Synonyms 17- allyl- 4, 5α - epoxy- 3, 14- dihydroxymorphinan- 6- one

Chemical data

Formula C19H21NO4

Molecular mass 327.37 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 10, 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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