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Erlotinib Hydrochloride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Erlotinib Hydrochloride CAS No:

Batch No: ERL/ 011114 A. R. No 14/ FP/ ERL/ 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 Off- white solid

2. Identification Complies

Complies H- NMR

HPLC R. t

3. Solubility Complies Complies

4. Loss on drying 0.23% NMT 0.5%

5. Residue on ignition 0.10% NMT 0.2%

6. Melting point 224.8ºC to 226.2ºC 223ºC to 228ºC

7. Related substances

Individual impurity

Total impurities

0.20%

0.30%

NMT 0.5%

NMT 1.0%

8. Heavy metals Complies NMT 20 PPM

9. Purity 99.80% NLT 99.0%

. .

Erlotinib

Erlotinib Structural Formulae. png

Erlotinib- 1m17- 3D- balls. png

Systematic ( IUPAC) name

N- ( 3- ethynylphenyl) - 6, 7- bis( 2- methoxyethoxy)

quinazolin- 4- amine

Clinical data

Trade names Tarceva

AHFS/ Drugs. com monograph

MedlinePlus a605008

Licence data EMA: Link, US FDA: link

Pregnancy

category

US: D ( Evidence of risk)

Legal status

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral tablets

Pharmacokinetic data

Bioavailability 59%

Protein binding 95%

Metabolism Hepatic ( mainly CYP3A4, less CYP1A2)

Biological half- life 36.2 hrs ( median)

Excretion >98% as metabolites, of which >90% via faeces, 9% via urine

Identifiers

CAS Registry Number 183321- 74- 6 Yes

ATC code L01XE03

PubChem CID: 176870

IUPHAR/ BPS 4920

DrugBank DB00530 Yes

ChemSpider 154044 Yes

UNII J4T82NDH7E Yes

KEGG D07907 Yes

ChEBI CHEBI: 114785 Yes

ChEMBL CHEMBL553 Yes

Chemical data

Formula C22H23N3O4

Molecular mass 393.436 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 8, 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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