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Fosphenytoin Sodium Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Fosphenytoin Sodium USP CAS No: 92134- 98- 0

Batch No: FOS/ 030313 A. R. No 13/ FP/ FOS/ 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.

Complies c) Sodium: Meets the requirements.

4. Related Substances

Individual Impurity Total Impurity

0.035 %

0.24%

NMT 0.1%

NMT 0.5%

5. pH 9.1 Between 8.5–9.5

6. Heavy Metals Complies 20ppm

7. Water Content by KF 4.7% 21.7% –25.7%

8. Assay HPLC 99.27% 98.0% –102.0%

Fosphenytoin

Fosphenytoin. svg

Fosphenytoin3d. png

Systematic ( IUPAC) name

( 2, 5- dioxo- 4, 4- diphenyl- imidazolidin- 1- yl) methoxyphosphonic acid

Clinical data

Trade names Cerebyx

AHFS/ Drugs. com monograph

MedlinePlus a604036

Pregnancy

category

US: D ( Evidence of risk)

Legal status

℞ ( Prescription only)

Routes of

administration Intravenous, intramuscular

Pharmacokinetic data

Bioavailability 100% ( IM)

Protein binding 95 to 99%

Metabolism Hepatic

Biological half- life 15 minutes to convert to phenytoin

Excretion Renal ( as phenytoin)

Identifiers

CAS Registry Number 93390- 81- 9 Yes

ATC code N03AB05

PubChem CID: 56339

IUPHAR/ BPS 7190

DrugBank DB01320 Yes

ChemSpider 50839 Yes

UNII B4SF212641 Yes

KEGG D07993 Yes

ChEMBL CHEMBL919

Chemical data

Formula C16H15N2O6P

Molecular mass 362.274 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 8, 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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