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Nitrofurantoin Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Nitrofurantoin USP CAS No: 67- 20- 9

Batch No: NIT/ 030313 A. R. No 13/ FP/ NIT/ 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 Very slightly soluble in water and in alcohol; soluble in dimethyl formamide. Very slightly soluble in water and in alcohol; soluble in dimethylformamide.

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. Water Content by KF 7.1% 6.5% –7.5%

5. Assay HPLC 99.45% 98.0% –102.0%

6. Specific Surface Area 0.12 m2/ g 0.045–0.20 m2/ g

Nitrofurantoin

Structural formula of nitrofurantoin

Ball- and- stick model of the nitrofurantoin molecule

Systematic ( IUPAC) name

( E) - 1- [ ( 5- nitro- 2- furyl) methylideneamino] imidazolidine- 2, 4- dione

Clinical data

Trade names Macrobid, Macrodantin and others

AHFS/ Drugs. com monograph

MedlinePlus a682291

Pregnancy

category

AU: A

US: B ( No risk in non- human studies)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration by mouth

Pharmacokinetic data

Bioavailability 40%

Metabolism liver ( 75% )

Biological half- life 20 minutes

Excretion urine and bile

Identifiers

CAS Registry Number 67- 20- 9 Yes

ATC code J01XE01

PubChem CID: 6604200

DrugBank DB00698 Yes

ChemSpider 5036498 Yes

UNII 927AH8112L Yes

KEGG D00439 Yes

ChEBI CHEBI: 71415

ChEMBL CHEMBL572 Yes

Chemical data

Formula C8H6N4O5

Molecular mass 238.16

SMILES[ show]

InChI[ show]

Physical data

Melting point 270 to 272 °C ( 518 to 522 °F) ( decomp. )


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 10, 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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