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Imipramine Hydrochloride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Imipramine Hydrochloride USP CAS No: 113- 52- 0

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

0.076 %

0.29%

NMT 0.2%

NMT 1.0%

5. Loss on drying 0.35% NMT 0.5%

6. Heavy Metals Complies 10ppm

7. Residue On Ignition 0.034% NMT 0.1%

8. Assay HPLC 99.26% 98.0% –102.0%

9. Melting Temperature 171º 170°–174°

Imipramine

Imipramine. svg

Imipramine- 3D- balls. png

Systematic ( IUPAC) name

3- ( 10, 11- dihydro- 5H- dibenzo[ b, f] azepin- 5- yl) - N, N- dimethylpropan- 1- amine

Clinical data

Trade names Tofranil

AHFS/ Drugs. com monograph

MedlinePlus a682389

Pregnancy

category

AU: C

US: N ( Not classified yet)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 94- 96% [ 1]

Protein binding 86% [ 2]

Metabolism Hepatic ( CYP1A2, CYP2C19, CYP2D6)

Main active metabolite desipramine[ 2]

Biological half- life 20 hours[ 2]

Excretion Renal ( 80% ) , Faecal ( 20% ) ( mostly as inactive metabolites) [ 2]

Identifiers

CAS Registry Number 50- 49- 7 Yes

ATC code N06AA02

PubChem CID: 3696

IUPHAR/ BPS 357

DrugBank DB00458 Yes

ChemSpider 3568 Yes

UNII OGG85SX4E4 Yes

KEGG D08070 Yes

ChEBI CHEBI: 47499 Yes

ChEMBL CHEMBL11 Yes

Chemical data

Formula C19H24N2

Molecular mass 280.407 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 9, 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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