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Pharmacopeial Impurities (EP / USP / BP)

Methotrexate EP Impurity I

Reference StandardAvailable on request

Methotrexate EP Impurity I (CAS 66147-29-3) supplier Zemixal. Lab and bulk packs, batch COA, fast global delivery. Catalogue no. ZX-022120.

Pack sizes
Methotrexate EP Impurity I chemical structure
CAS number66147-29-3
FormulaC21H24N8O5
Molar mass468.5 g/mol
Physical formSolid
HS code38229090
InChIKeyJYFDQHNTJJOKAS-AWEZNQCLSA-N
IUPAC name(4S)-4-[[4-[(2,4-diaminopteridin-6-yl)methyl-methylamino]benzoyl]amino]-5-methoxy-5-oxopentanoic acid

About Methotrexate EP Impurity I

Methotrexate EP Impurity I is supplied by Zemixal as a characterised reference material for Methotrexate analysis. For your records (Reference Standard), the material is defined by CAS 66147-29-3, formula C21H24N8O5 and molar mass 468.5 g/mol. It is handled as a solid.

Use cases we see most often

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

Safe handling

Classified under GHS with signal word Danger and hazard statements H301, H315, H319 and H335. Read the SDS before first use.

Available as 10 mg, 25 mg, 50 mg and 100 mg. Larger or split packs can be arranged. Every shipment includes a certificate of analysis with characterisation data. Send an enquiry through the quote panel and you get a formal offer with Incoterms and delivery time.

Reference standards for Methotrexate

See every impurity, metabolite and related compound we list for this API.

Methotrexate standards

Typical uses

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

Applications

Pharmaceutical Manufacturing and QCResearch Labs and Universities

Grade guides

Ph. Eur. Grade (European Pharmacopoeia)

Specifications and identifiers

Specifications of Methotrexate EP Impurity I
Product nameMethotrexate EP Impurity I
Catalogue numberZX-022120
CAS number66147-29-3
IUPAC name(4S)-4-[[4-[(2,4-diaminopteridin-6-yl)methyl-methylamino]benzoyl]amino]-5-methoxy-5-oxopentanoic acid
Molecular formulaC21H24N8O5
Molar mass468.5 g/mol
Exact mass468.187
GradeReference Standard
Physical formSolid
XLogP3-1.5
H-bond donors / acceptors4 / 12
Topological polar surface area200 Ų
HS code38229090
InChIKeyJYFDQHNTJJOKAS-AWEZNQCLSA-N
SMILESCN(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 CID72941585
SynonymsMethotrexate - 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

Lot values are stated on the batch certificate of analysis. Ask for a typical COA with your quotation.

Safety and GHS hazards

GHS06 Acute toxicity
Acute toxicity
GHS07 Irritant or harmful
Irritant or harmful
GHS08 Health hazard
Health hazard

Signal word Danger

  • 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 summarised from public GHS notifications. It can vary with grade and concentration, so always follow the SDS supplied with your lot.

Pack sizes

Pack sizes of Methotrexate EP Impurity I
10 mgQuoted on request
25 mgQuoted on request
50 mgQuoted on request
100 mgQuoted on request

Need a different size? Bulk drums and custom packing are quoted on request through the quote form on this page.

Questions about Methotrexate EP Impurity I

Which CAS number identifies Methotrexate EP Impurity I?
Methotrexate EP Impurity I is registered under CAS 66147-29-3. You may also see it listed as Methotrexate - Impurity I, Methotrexate 1-methyl ester, Methotrexate alpha-methyl ester. Our catalogue number for this item is ZX-022120.
What are the formula and molar mass of Methotrexate EP Impurity I?
For Methotrexate EP Impurity I, its formula is C21H24N8O5 and its molar mass is 468.5 g/mol. The systematic (IUPAC) name is (4S)-4-[[4-[(2,4-diaminopteridin-6-yl)methyl-methylamino]benzoyl]amino]-5-methoxy-5-oxopentanoic acid. InChIKey JYFDQHNTJJOKAS-AWEZNQCLSA-N lets you match it in any structure database.
How is Methotrexate EP Impurity I used in pharmaceutical QC?
Methotrexate EP Impurity I is a characterised reference material linked to Methotrexate. Laboratories use it to identify and quantify this impurity during method development and validation, stability work, batch release testing and regulatory submissions.
What grade and pack sizes are available for Methotrexate EP Impurity I?
This listing is Reference Standard grade. Standard packs are 10 mg, 25 mg, 50 mg, 100 mg. Larger quantities and custom packing can be quoted on request.
Which documents come with Methotrexate EP Impurity I?
Each lot ships with a batch certificate of analysis and a 16-section GHS safety data sheet. A typical COA or specification sheet can be shared with the quotation before you order.
Can Zemixal ship Methotrexate EP Impurity I to my country?
Yes. Because Methotrexate EP Impurity I is classed as hazardous, it travels in UN-approved packaging as dangerous goods under IATA or IMDG rules, with the export paperwork your broker needs.

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