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Nizatidine Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Nizatidine USP CAS No: 76963- 41- 2

Batch No: NIZ/ 030313 A. R. No 13/ FP/ NIZ/ 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 Total Impurity

0.097%

0.78%

NMT 0.3%

NMT 1.5%

5. Loss on drying 0.65% NMT 1.0%

6. Heavy Metals Complies 10ppm

7. Residue On Ignition 0.056% NMT 0.1%

8. Assay HPLC 100.03% 98.0% –101.0%

Nizatidine structure. png

Systematic ( IUPAC) name

N- ( 2- [ ( 2- [ ( dimethylamino) methyl] thiazol- 4- yl) methylthio] ethyl) - N- methyl- 2- nitroethene- 1, 1- diamine

Clinical data

Trade names Axid

AHFS/ Drugs. com monograph

MedlinePlus a694030

Licence data US FDA: link

Pregnancy

category

AU: B3

Legal status

AU: Prescription Only ( S4)

UK: Prescription- only ( POM)

US: ℞ - only and OTC[ 1]

Routes of

administration Oral

Pharmacokinetic data

Bioavailability >70%

Protein binding 35%

Metabolism Hepatic

Biological half- life 1- 2 hours

Excretion Renal

Identifiers

CAS Registry Number 76963- 41- 2 Yes

ATC code A02BA04

PubChem CID: 3033637

IUPHAR/ BPS 7248

DrugBank DB00585 Yes

ChemSpider 2298266 Yes

UNII P41PML4GHR Yes

KEGG D00440 Yes

ChEBI CHEBI: 7601

ChEMBL CHEMBL653 Yes

Chemical data

Formula C12H21N5O2S2

Molecular mass 331.46 g/ mol


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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