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Duloxetine Hydrochloride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Duloxetine hydrochloride CAS No: 136434- 34- 9

Batch No: DUL/ 011114 A. R. No 14/ FP/ DUL/ 0111

Date of Manufacture Nov- 2014 Date of Analysis 02- 11- 14

Batch Quantity 100 kg Date of Retest Jan- 2017

Sr. No Test Results Acceptance Criteria

1. Appearance Complies A white to almost white crystalline powder

2. Identification Complies The IR absorption spectrum is accordant with

the spectrum obtained with CRS

3. Assay 100.31% 97.5% to 102.0%

4. Solubility Complies Soluble in methanol, slightly soluble in water,

almost insoluble in n- hexane

5. Residue on ignition 0.07% NMT 0.1%

6. Heavy metals Complies NMT 0.001%

7. Loss on drying 0.02% NMT 0.5%

8. Related substances

Impurity F

Unknown impurity

Total impurities

0.06%

0.008%

0.08%

NMT 0.4%

NMT 0.1%

NMT 0.5%

9. Chirality Not detected NMT 0.5%

10. Residual solvents

Ethanol

Ethyl acetate

Cycohexane

Toulene

0.02%

Not detected

Not detected

NMT 0.194%

NMT 0.089%

Duloxetine

Duloxetine. svg

Duloxetine- 3D- ball- model. png

Systematic ( IUPAC) name

( +) - ( S) - N- Methyl- 3- ( naphthalen- 1- yloxy) - 3- ( thiophen- 2- yl) propan- 1- amine

Clinical data

Trade names Cymbalta

AHFS/ Drugs. com monograph

MedlinePlus a604030

Licence data EMA: Link, US FDA: link

Pregnancy

category

AU: B3

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability ~ 50% ( 32% to 80% )

Protein binding ~ 95%

Metabolism Liver, two P450 isozymes, CYP2D6 and CYP1A2

Biological half- life 12.1 hours

Excretion 70% in urine, 20% in feces

Identifiers

CAS Registry Number 116539- 59- 4 ( free base)

136434- 34- 9 ( hydrochloride)

ATC code N06AX21

PubChem CID: 60835

IUPHAR/ BPS 202

DrugBank DB00476 Yes

ChemSpider 54822 Yes

UNII O5TNM5N07U Yes

KEGG D07880 Yes

ChEBI CHEBI: 36795 Yes

ChEMBL CHEMBL1175 Yes

PDB ligand ID 29E ( PDBe, RCSB PDB)

Chemical data

Formula C18H19NOS

Molecular mass 297.41456 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 7, 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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