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Asenapine Maleate Usp Ep Ip Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Asenapine maleate CAS No: 85650- 56- 2

Batch No: ASE/ 011114 A. R. No 14/ FP/ ASE/ 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 Off- white to slight yellow powder

2. DENTIFICATION Complies HPLC, NMR

3. Loss on drying 0.10% NMT 1.0%

4. Residue on ignition 0.09% NMT 0.2%

5. Heavy metals Complies NMT 20 PPM

6. Single impurities 0.47% NMT 0.5%

7. Purity 99.37% NLT 99.0%

.

Asenapine

Skeletal formula of asenapine

Ball- and- stick model of the asenapine molecule

Systematic ( IUPAC) name

( 3aRS, 12bRS) - rel- 5- Chloro- 2, 3, 3a, 12b- tetrahydro-

2- methyl- 1H- dibenz[ 2, 3: 6, 7] oxepino[ 4, 5- c] pyrrole

Clinical data

Trade names Saphris, Sycrest

AHFS/ Drugs. com monograph

MedlinePlus a610015

Licence data EMA: Link, US FDA: link

Pregnancy

category

AU: C

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration sublingual

Pharmacokinetic data

Bioavailability 35% ( sublingual) , <2% ( Oral) [ 1] [ 2] [ 3] [ 4]

Protein binding 95% [ 1] [ 2] [ 3] [ 4]

Metabolism hepatic ( glucurinodation by UGT1A4 and oxidative metabolism by CYP1A2) [ 1] [ 2] [ 3] [ 4]

Biological half- life 24 hours[ 1] [ 2] [ 3] [ 4]

Excretion Renal ( 50% ) , Faecal ( 40% ; ~5- 16% as unchanged drug in faeces) [ 1] [ 2] [ 3] [ 4]

Identifiers

CAS Registry Number 65576- 45- 6

ATC code N05AH05

PubChem CID: 163091

IUPHAR/ BPS 22

ChemSpider 2300725 Yes

UNII JKZ19V908O Yes

ChEBI CHEBI: 71253

ChEMBL CHEMBL1201756

Chemical data

Formula C17H16ClNO

Molecular mass 285.77 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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