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Methotrexate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Methotrexate USP CAS No: 59- 05- 2

Batch No: MET/ 030313 A. R. No 13/ FP/ MET/ 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. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +21º Between - +19° to +24°

5. Water Content by KF 6.7% NMT 12.0%

6. Residue On Ignition 0.045% NMT 0.1%

7. Assay HPLC 99.34% 98.0% –102.0%

Methotrexate

Methotrexate skeletal. svg

Methotrexate ball- and- stick model. png

Systematic ( IUPAC) name

( 2S) - 2- [ ( 4- { [ ( 2, 4- Diaminopteridin- 6- yl) methyl] ( methyl) amino} benzoyl) amino] pentanedioic acid

Clinical data

Trade names Trexall

AHFS/ Drugs. com monograph

MedlinePlus a682019

Licence data US FDA: link

Pregnancy

category

AU: D

US: X ( Contraindicated)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

℞ ( Prescription only)

Routes of

administration oral, IV, IM, SC, intrathecal

Pharmacokinetic data

Bioavailability 60% at lower doses, less at higher doses. [ 1]

Protein binding 35- 50% ( parent drug) , [ 1] 91- 93% ( 7- hydroxymethotrexate) [ 2]

Metabolism Hepatic and intracellular[ 1]

Biological half- life 3- 10 hours ( lower doses) , 8- 15 hours ( higher doses) [ 1]

Excretion Urine ( 80- 100% ) , faeces ( small amounts) [ 1] [ 2]

Identifiers

CAS Registry Number 59- 05- 2 Yes

ATC code L01BA01 L04AX03

PubChem CID: 126941

IUPHAR/ BPS 4815

DrugBank DB00563 Yes

ChemSpider 112728 Yes

UNII YL5FZ2Y5U1 Yes

KEGG D00142 Yes

ChEBI CHEBI: 44185 Yes

ChEMBL CHEMBL34259 Yes

Chemical data

Formula C20H22N8O5

Molecular mass 454.44 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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