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Dantrolene Sodium Usp - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Dantrolene Sodium USP CAS No: 24868- 20- 0

Batch No: DAN/ 030313 A. R. No 13/ FP/ DAN/ 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 of the flame test for sodium.

4. Related Substances

Total Impurity

0.05%

NMT 0.15%

5. Water Content by KF 14.7% 14.5% –17.0%

6. Heavy metals Complies NMT 20ppm

7. Assay HPLC 94.27% 90.0% –96.0%

Dantrolene

Structural formula of dantrolene

Space- filling model of the dantrolene molecule

Systematic ( IUPAC) name

1- { [ 5- ( 4- nitrophenyl) - 2- furyl] methylideneamino}

imidazolidine- 2, 4- dione

Clinical data

Trade names Dantrium

AHFS/ Drugs. com monograph

Pregnancy

category

US: C ( Risk not ruled out)

Routes of

administration Oral, intravenous

Pharmacokinetic data

Bioavailability 70%

Metabolism Liver

Excretion Biliary, renal

Identifiers

CAS Registry Number 7261- 97- 4 Yes

ATC code M03CA01

PubChem CID: 2952

IUPHAR/ BPS 4172

DrugBank DB01219 Yes

ChemSpider 2847 Yes

UNII F64QU97QCR Yes

KEGG D02347

ChEBI CHEBI: 4317 Yes

ChEMBL CHEMBL1201288

Chemical data

Formula C14H10N4O5

Molecular mass 314.253 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 7, 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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