Methotrexate EP Impurity I

Name: Methotrexate EP Impurity I
Brand: Vaqora Chemicals
SKU: VQ-023094

About Methotrexate EP Impurity I

Listed under CAS 66147-29-3, Methotrexate EP Impurity I is a pharmacopeial impurity of Methotrexate available from Vaqora Chemicals. Its molecular formula is C21H24N8O5 and its molecular weight is 468.5 g/mol. Systematically, it is named (4S)-4-[[4-[(2,4-diaminopteridin-6-yl)methyl-methylamino]benzoyl]amino]-5-methoxy-5-oxopentanoic acid. Common synonyms include Methotrexate - Impurity I and Methotrexate 1-methyl ester.

The product is provided as a solid. Keep the vial tightly closed, protected from light and humidity, at the temperature stated on the Certificate of Analysis. It carries the GHS signal word “Danger” with 5 hazard statements. Review the Safety Data Sheet before use.

Pharmaceutical QC and development laboratories use this impurity standard of Methotrexate to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. It is used across pharmaceutical manufacturing and academic and industrial research.

Vaqora Chemicals supplies Methotrexate EP Impurity I in 10 mg, 25 mg, 50 mg and 100 mg packs, each shipped with a Certificate of Analysis (COA), and exports worldwide.

Typical applications

Pharmacopeial method verification
Impurity profiling
QC release testing
ANDA / DMF filings

Industries

Related to Methotrexate

View every impurity, metabolite and intermediate we list for Methotrexate.

Methotrexate impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Methotrexate EP Impurity I
Catalogue No.	VQ-023094
CAS Number	66147-29-3
IUPAC name	(4S)-4-[[4-[(2,4-diaminopteridin-6-yl)methyl-methylamino]benzoyl]amino]-5-methoxy-5-oxopentanoic acid
Molecular formula	C₂₁H₂₄N₈O₅
Molecular weight	468.5 g/mol
Exact mass	468.187
Grade	Reference Standard
HSN code	38229090
InChIKey	JYFDQHNTJJOKAS-AWEZNQCLSA-N
SMILES	CN(CC1=CN=C2C(=N1)C(=NC(=N2)N)N)C3=CC=C(C=C3)C(=O)N[C@@H](CCC(=O)O)C(=O)OC
PubChem CID	72941585

Physical properties
Physical form	Solid
LogP (XLogP3)	-1.5
H-bond donors / acceptors	4 / 12
TPSA	200 Å²
Synonyms	Methotrexate - Impurity I, Methotrexate 1-methyl ester, Methotrexate alpha-methyl ester, Methotrexate specified impurity I, Methotrexate a-Methyl Ester, Methotrexate impurity I, Methotrexate-1-monomethyl ester

Safety & hazard information (GHS)

Toxic

Harmful / irritant

Health hazard

Signal word: Danger

Hazard statements

H301Toxic if swallowed
H315Causes skin irritation
H319Causes serious eye irritation
H335May cause respiratory irritation
H341Suspected of causing genetic defects

Precautionary statements: P203, P261, P264, P264 + P265, P270, P271, P280, P301 + P316, P302 + P352, P304 + P340, P305 + P351 + P338, P318, P319, P321, P330, P332 + P317, P337 + P317, P362 + P364, P403 + P233, P405, P501

Classification is indicative (aggregated GHS notifications) and may vary by grade and concentration. Always refer to the SDS supplied with your lot.

Documents

Safety Data Sheet (SDS)16-section GHS · on request Certificate of AnalysisTypical / batch COA · on request Specification sheetTDS / MOA · on request

Frequently asked questions

What is the CAS number of Methotrexate EP Impurity I?

The CAS Registry Number of Methotrexate EP Impurity I is 66147-29-3. It is also known as Methotrexate - Impurity I, Methotrexate 1-methyl ester, Methotrexate alpha-methyl ester.

What is the molecular formula and molecular weight of Methotrexate EP Impurity I?

Methotrexate EP Impurity I has the molecular formula C21H24N8O5 and a molecular weight of 468.5 g/mol. Its IUPAC name is (4S)-4-[[4-[(2,4-diaminopteridin-6-yl)methyl-methylamino]benzoyl]amino]-5-methoxy-5-oxopentanoic acid.

What is Methotrexate EP Impurity I used for?

Methotrexate EP Impurity I is supplied as a characterised reference material related to Methotrexate. It is used for analytical method development and validation (AMV), impurity profiling, stability studies and quality control, and in ANDA/DMF regulatory filings.

Which grade and pack sizes of Methotrexate EP Impurity I can I order?

We supply Methotrexate EP Impurity I in Reference Standard grade, in 10 mg, 25 mg, 50 mg, 100 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Methotrexate EP Impurity I?

Yes. Every lot of Methotrexate EP Impurity I is shipped with a batch-specific Certificate of Analysis, and a 16-section GHS Safety Data Sheet is provided with the quotation and the shipment.

Can Methotrexate EP Impurity I be shipped internationally?

Yes. Methotrexate EP Impurity I is classified as hazardous, so it is packed in UN-approved packaging and shipped as dangerous goods under IATA/IMDG rules. We export worldwide on EXW, FOB, CIF and DAP terms.