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Lubiprostone Usp Ip Ep Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Lubiprostone CAS No: 333963- 40- 9,

136790- 76- 6

Batch No: LUB/ 011114 A. R. No 14/ FP/ LUB/ 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 White crystals or crystalline

powder, odorless

2. Identification Complies HPLC

3. Water 0.22% NMT 0.5%

4. Single impurity 0.15% NMT 0.5%

5. Total impurities 0.26% NMT 1.0%

6. Residue on ignition 0.04% NMT 0.1%

7. Residual solvents

N- Hexane

Ethyl acetate

ND

0.12%

NMT 0.029%

NMT 0.5%

8. Purity 99.74% NLT 99.0%

.

Lubiprostone

Lubiprostone. svg

Systematic ( IUPAC) name

7- [ ( 1R, 3R, 6R, 7R) - 3- ( 1, 1- Difluoropentyl) - 3- hydroxy- 8- oxo- 2- oxabicyclo[ 4.3.0] non- 7- yl] heptanoic acid

Clinical data

Trade names Amitiza

AHFS/ Drugs. com monograph

MedlinePlus a607034

Licence data US FDA: link

Pregnancy

category

US: C ( Risk not ruled out)

Legal status

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability Negligible

Protein binding 94%

Metabolism Extensive, CYP not involved

Biological half- life Unknown ( lubiprostone)

0.9–1.4 hours ( main metabolite)

Excretion Renal ( 60% ) and fecal ( 30% )

Identifiers

CAS Registry Number 136790- 76- 6 Yes

ATC code A06AX03

PubChem CID: 157920

IUPHAR/ BPS 4242

DrugBank DB01046 Yes

ChemSpider 138948 Yes

UNII 7662KG2R6K Yes

KEGG D04790 Yes

ChEMBL CHEMBL1201134

Synonyms Amitiza

RU- 0211

SPI- 0211

Chemical data

Formula C20H32F2O5

Molecular mass 390.462 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 9, 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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