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Emedastine Difumarate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Emedastine Difumarate USP CAS No: 87233- 62- 3

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

0.09%

0.56%

NMT 0.3%

NMT 1.0%

5. pH 3.4 Between 3.0–4.5

6. Loss on drying NMT 0.5%

7. Heavy Metals Complies 20ppm

8. Residue On Ignition 0.03% NMT 0.1%

9. Assay 99.3% 98.5% –101.0%

Loratadine

Loratadine. svg

Loratadine - 3d, portrait orientation. png

Systematic ( IUPAC) name

Ethyl 4- ( 8- chloro- 5, 6- dihydro- 11H- benzo[ 5, 6] cyclohepta[ 1, 2- b] pyridin- 11- ylidene) - 1- piperidinecarboxylate

Clinical data

Trade names Claritin

AHFS/ Drugs. com monograph

MedlinePlus a697038

Pregnancy

category

AU: B1

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

Legal status

CA: OTC

UK: General sales list ( GSL, OTC)

US: OTC

Routes of

administration oral

Pharmacokinetic data

Bioavailability almost 100%

Protein binding 97–99%

Metabolism Hepatic ( CYP2D6- and 3A4- mediated)

Biological half- life 8 hours, active metabolite desloratadine 27 hours

Excretion 40% as conjugated metabolites into urine

Similar amount into the feces

Identifiers

CAS Registry Number 79794- 75- 5 Yes

ATC code R06AX13

PubChem CID: 3957

IUPHAR/ BPS 7216

DrugBank DB00455

ChemSpider 3820 Yes

UNII 7AJO3BO7QN Yes

KEGG D00364 Yes

ChEMBL CHEMBL998 Yes

Chemical data

Formula C22H23ClN2O2

Molecular mass 382.88 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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