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Bendamustine Hydrochloride Usp Ip Ep Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Bendamustine hydrochloride CAS No:

Batch No: AZI/ 011114 A. R. No 14/ FP/ AZI/ 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 to off- white powder

2. Solubility Complies Free soluble in methanol, water; insoluble in chloroform

3. Identification Complies

λ max1=232nm

λ max2=330nm

Complies Gives reaction of chloride

IR: λ max1=233nm;

λ max2=330nm;

IR: comply with the spectrum of bendamustine HCL standard

4. Appearance of solution Complies Clear and colorless

5. PH 3.2 2.5 to 3.5

6. Loss on drying 0.8% NMT 2.0%

7. Heavy metals Complies NMT 20 PPM

8. Assay 99.6% NLT 98.5%

Bendamustine

Bendamustine. png

Systematic ( IUPAC) name

4- [ 5- [ Bis( 2- chloroethyl) amino] - 1- methylbenzimidazol- 2- yl] butanoic acid

Clinical data

Trade names Treanda

AHFS/ Drugs. com Consumer Drug Information

MedlinePlus a608034

Licence data US FDA: link

Pregnancy

category

US: D ( Evidence of risk)

Legal status

US: ℞ - only

Routes of

administration Intravenous infusion

Pharmacokinetic data

Bioavailability NA ( intravenous only)

Protein binding 94–96%

Metabolism Hydrolyzed to inactive metabolites. Two minor metabolites ( M3 and M4) formed by CYP1A2

Biological half- life 40 min ( bendamustine) , 3 h ( M3) , 30 min ( M4)

Excretion ~50% urinary, ~25% fecal [ 1]

Identifiers

CAS Registry Number 16506- 27- 7 Yes

ATC code L01AA09

PubChem CID: 65628

IUPHAR/ BPS 7478

ChemSpider 59069 Yes

UNII 9266D9P3PQ Yes

ChEMBL CHEMBL487253 Yes

Chemical data

Formula C16H21Cl2N3O2

Molecular mass 358.262 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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