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Mirtazapine Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Mirtazapine USP CAS No: 61337- 67- 5

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

0.03%

0.14%

NMT 0.1%

NMT 0.5%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +1.2º Between +2° to - 2°

6. Heavy Metals Complies 10ppm

7. Water Content by KF 2.3% 1.0% –3.5%

8. Residue On Ignition 0.067% NMT 0.1%

9. Assay HPLC 99.34% 98.0% –102.0%

.

Mirtazapine

Mirtazapine 2D structure. svg

Mirtazapine- 3D- ball- model. png

Systematic ( IUPAC) name

( ±) - 2- methyl- 1, 2, 3, 4, 10, 14b- hexahydropyrazino[ 2, 1- a] pyrido[ 2, 3- c] [ 2] benzazepine

Clinical data

Trade names Remeron, Avanza, Axit, Mirtazon, Zispin

AHFS/ Drugs. com monograph

MedlinePlus a697009

Licence data US FDA: link

Pregnancy

category

AU: B3

US: C ( Risk not ruled out)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 50% [ 1] [ 2] [ 3] [ 4]

Protein binding 85% [ 1] [ 2] [ 3] [ 4]

Metabolism Liver ( CYP1A2, CYP2D6 and CYP3A4) [ 1] [ 2] [ 3] [ 4] [ 5]

Biological half- life 20–40 hours[ 1] [ 2] [ 3] [ 4]

Excretion Urine ( 75% ) [ 1]

Faeces ( 15% ) [ 1] [ 2] [ 3] [ 4]

Identifiers

CAS Registry Number 61337- 67- 5 Yes

ATC code N06AX11

PubChem CID: 4205

IUPHAR/ BPS 7241

DrugBank DB00370 Yes

ChemSpider 4060 Yes

UNII A051Q2099Q

KEGG D00563 Yes

ChEBI CHEBI: 6950

ChEMBL CHEMBL654 Yes

Synonyms 6- Azamianserin, Org 3770

Chemical data

Formula C17H19N3

Molecular mass 265.35 g/ mol

SMILES[ show]

InChI[ show]

Physical data

Density 1.22 g/ cm3

Melting point 114 to 116 °C ( 237 to 241 °F)

Boiling point 432 °C ( 810 °F)

Solubility in water Soluble in methanol and chloroform mg/ mL ( 20 °C)


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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