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Clemastine Fumarate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Clemastine fumarate CAS No: 14976- 57- 9

Batch No: CLE/ 011114 A. R. No 14/ FP/ CLE/ 0111

Date of Manufacture Nov- 2014 Date of Analysis 02- 11- 14

Batch Quantity 100 kg Date of Retest Jan- 2017

Sr. No Test Results Acceptance Criteria

1. Appearance Complies White to almost white crystalline powder

2. Solubility Complies Slightly soluble in methanol, very slightly soluble in water and trichloromethane

3. Identification Complies

Complies The principal spot obtained from the Test preparation corresponds in RF value, color, and intensity to that obtained from the Standard preparation

Infrared absorption spectrophotometry conforms with the reference spectrum

4. Clarity and Color

of Methanol Solution Complies The test solution is colorless or not more intensely colored than Color matching fluid

5. PH 3.6 3.2 to 4.2

6. Related substance

Single impurity

Total impurities

0.13%

0.28%

NMT 0.5%

NMT 1.0%

7. Loss on drying 0.03% NMT 0.5%

8. Heavy metals Complies NMT 0.002%

9. Assay 99.7% 98.0% to 102.0%

. .

Clemastine

Clemastine. svg

Clemastine ball- and- stick. png

Systematic ( IUPAC) name

( 2R) - 2- { 2- [ ( 1R) - 1- ( 4- chlorophenyl) - 1- phenylethoxy] ethyl} - 1- methylpyrrolidine

Clinical data

AHFS/ Drugs. com monograph

MedlinePlus a682542

Pregnancy

category

B ( USA)

Legal status

Unscheduled;

OTC

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 39.2%

Metabolism Hepatic

Biological half- life 21.3 Hours

Excretion Renal

Identifiers

CAS Registry Number 15686- 51- 8 Yes

ATC code D04AA14 R06AA04

PubChem CID: 26987

IUPHAR/ BPS 6063

DrugBank DB00283 Yes

ChemSpider 25129 Yes

UNII 95QN29S1ID Yes

KEGG D03535 Yes

ChEBI CHEBI: 3738 Yes

ChEMBL CHEMBL1626 Yes

Chemical data

Formula C21H26ClNO

Molecular mass 343.9 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 6, 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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