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Key Documents

PHR1396

Supelco

Methotrexate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

Methotrexate, (+)-Amethopterin, 4-Amino-10-methylfolic acid, 4-Amino-N10-methylpteroyl-L-glutamic acid, Antifolan, MTX, Methylaminopterin

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About This Item

Formule empirique (notation de Hill):
C20H22N8O5
Numéro CAS:
Poids moléculaire :
454.44
Numéro Beilstein :
70669
Numéro CE :
Numéro MDL:
Code UNSPSC :
41116107
ID de substance PubChem :
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

Agence

traceable to Ph. Eur. M1000000
traceable to USP 1414003

Famille d'API

methotrexate

CofA (certificat d'analyse)

current certificate can be downloaded

Technique(s)

HPLC: suitable
gas chromatography (GC): suitable

Application(s)

pharmaceutical (small molecule)

Format

neat

Température de stockage

2-8°C

Chaîne SMILES 

CN(Cc1cnc2nc(N)nc(N)c2n1)c3ccc(cc3)C(=O)N[C@@H](CCC(O)=O)C(O)=O

InChI

1S/C20H22N8O5/c1-28(9-11-8-23-17-15(24-11)16(21)26-20(22)27-17)12-4-2-10(3-5-12)18(31)25-13(19(32)33)6-7-14(29)30/h2-5,8,13H,6-7,9H2,1H3,(H,25,31)(H,29,30)(H,32,33)(H4,21,22,23,26,27)/t13-/m0/s1

Clé InChI

FBOZXECLQNJBKD-ZDUSSCGKSA-N

Informations sur le gène

human ... DHFR(1719)

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Description générale

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Methotrexate is an antagonist of folic acid that inhibits dihydrofolate reductase (DHFR) enzyme, reversibly and results in impaired DNA synthesis and cellular replication. Methotrexate has been used in treatment of rheumatoid arthritis and also for maintenance therapy in childhood acute lymphocytic leukemia (ALL).

Application

Methotrexate may be used as a pharmaceutical secondary reference standard for the determination of the analyte in plasma samples and pharmaceutical formulations by various techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Remarque sur l'analyse

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Autres remarques

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAB9958 in the slot below. This is an example certificate only and may not be the lot that you receive.

Produits recommandés

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Pictogrammes

Skull and crossbonesHealth hazard

Mention d'avertissement

Danger

Mentions de danger

Classification des risques

Acute Tox. 3 Oral - Muta. 2 - Repr. 1B - STOT RE 1

Organes cibles

Liver,Bone marrow

Code de la classe de stockage

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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Certificats d'analyse (COA)

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Les clients ont également consulté

Methotrexate mechanism in treatment of rheumatoid arthritis
Friedman B and Cronstein B
Joint, Bone, Spine : Revue du Rhumatisme, 86(3), 301-307 (2018)
Determination of methotrexate in plasma by on-column concentration and ion-exchange chromatography
Lankelma J and Poppe H
Journal of Chromatography A, 149(5), 587-598 (1978)
Fetal methotrexate syndrome: A systematic review of case reports
Verberne EA, et al.
Reproductive Toxicology, 87, 125-139 (2019)
Methotrexate determination in pharmaceuticals by enantioselective HPLC
El-Hady DA, et al.
Journal of Pharmaceutical and Biomedical Analysis, 37(5), 919-925 (2005)
Methotrexate bioavailability after oral and intramuscular administration in children
Teresi ME, et al.
The Journal of Pediatrics, 110(5), 788-792 (1987)

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