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Mexiletine Hydrochloride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Mexiletine Hydrochloride USP CAS No: 5370- 01- 4

Batch No: MEX/ 030313 A. R. No 13/ FP/ MEX/ 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 By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

4. Related Substances

Individual Impurity Total Impurity

0.32 %

1.1%

NMT 1.0%

NMT 1.5%

5. pH 4.1 Between 3.5–5.5

6. Loss on drying 0.18% NMT 0.5%

7. Heavy Metals Complies 10ppm

8. Residue On Ignition 0.067% NMT 0.1%

9. Assay HPLC 99.67% 98.0% –102.0%

. .

Mexiletine

Mexiletine. svg

Systematic ( IUPAC) name

( RS) - 1- ( 2, 6- dimethylphenoxy) propan- 2- amine

OR

2- ( 2- aminopropoxy) - 1, 3- dimethylbenzene

Clinical data

AHFS/ Drugs. com monograph

MedlinePlus a607064

Pregnancy

category

AU: B1

US: C ( Risk not ruled out)

Legal status

UK: Prescription- only ( POM)

Routes of

administration Oral, IV

Pharmacokinetic data

Bioavailability 90%

Protein binding 50- 60%

Metabolism Hepatic ( CYP2D6 and 1A2- mediated)

Biological half- life 10- 12 hours

Excretion Renal ( 10% )

Identifiers

CAS Registry Number 31828- 71- 4 Yes

ATC code C01BB02

PubChem CID: 4178

IUPHAR/ BPS 2629

DrugBank DB00379 Yes

ChemSpider 4034 Yes

UNII 1U511HHV4Z Yes

KEGG D08215 Yes

ChEBI CHEBI: 6916 Yes

ChEMBL CHEMBL558 Yes

Chemical data

Formula C11H17NO

Molecular mass 179.259 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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