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Ifosfamide Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Ifosfamide USP CAS No: 3778- 73- 2

Batch No: IFO/ 030313 A. R. No 13/ FP/ IFO/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification

Complies a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

4. Related Substances

Individual Impurity

0.087%

NMT 0.25%

5. pH 3.4 Between 4.0–7.0

6. Heavy Metals Complies 20ppm

7. Water Content by KF 0.11% NMT 0.3%

8. Bacterial Endotoxins Test 0.098EU/ mg NMT 0.125 EU/ mg

9. Assay HPLC 99.78% 98.0% –102.0%

.

Ifosfamide

Ifosfamide racemate2DCSD. svg

( R) - ifosfamide ( S) - ifosfamide

Systematic ( IUPAC) name

N- 3- bis( 2- chloroethyl) - 1, 3, 2- oxazaphosphinan- 2- amide- 2- oxide

Clinical data

Trade names Ifex

AHFS/ Drugs. com monograph

MedlinePlus a695023

Pregnancy

category

AU: D

US: D ( Evidence of risk)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

NZ: Prescription Medicine

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration intravenously

Pharmacokinetic data

Bioavailability 100%

Metabolism Hepatic

Biological half- life 60- 80% in 72 hours

Excretion Renal

Identifiers

CAS Registry Number 3778- 73- 2 Yes

ATC code L01AA06

PubChem CID: 3690

IUPHAR/ BPS 7201

DrugBank DB01181 Yes

ChemSpider 3562 Yes

UNII UM20QQM95Y Yes

KEGG D00343 Yes

ChEBI CHEBI: 5864 Yes

ChEMBL CHEMBL1024 Yes

Synonyms 3- ( 2- chloroethyl) - 2- [ ( 2- chloroethyl) amino] tetrahydro- 2H- 1, 3, 2- oxazaphosphorine 2- oxide

Chemical data

Formula C7H15Cl2N2O2P

Molecular mass 261.1 g mol− 1


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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