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Levetiracetam Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Levetiracetam CAS No:

Batch No: LEV/ 011114 A. R. No 14/ FP/ LEV/ 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. Identification Complies

Complies HPLC

IR

2. Water 0.17% NMT 0.5%

3. Residue on ignition 0.04% NMT 0.1%

4. Heavy metals Complies NMT 20 PPM

5. D- levetiracetam 0.07% NMT 80%

6. Related substances

Compound B

Not detected

NMT 0.10%

7. Related substances

Levetiracetam acid

Compound A

Any other individual impurity

Total impurities

Not detected

Complies

0.09%

NMT 0.30%

NMT 0.05%

NMT 0.40%

8. Assay 99.03% 98% to 102%

.

Levetiracetam

Levetiracetam. svg

Levetiracetam3d. png

Systematic ( IUPAC) name

( S) - 2- ( 2- Oxopyrrolidin- 1- yl) butanamide

Clinical data

AHFS/ Drugs. com monograph

MedlinePlus a699059

Licence data US FDA: link

Pregnancy

category

AU: B3

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

US: ℞ - only

℞ ( Prescription only)

Routes of

administration Oral, intravenous

Pharmacokinetic data

Bioavailability ~100%

Protein binding <10%

Metabolism Enzymatic hydrolysis of acetamide group

Biological half- life 6 - 8 hr

Excretion Urinary

Identifiers

CAS Registry Number 102767- 28- 2 Yes

ATC code N03AX14

PubChem CID: 5284583

IUPHAR/ BPS 6826

DrugBank DB01202

ChemSpider 4447633 Yes

UNII 44YRR34555 Yes

KEGG D00709 Yes

ChEBI CHEBI: 6437

ChEMBL CHEMBL1286 Yes

Chemical data

Formula C8H14N2O2

Molecular mass 170.209 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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