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Pharmacopeial Impurities (EP / USP / BP)

Fingolimod EP Impurity I

Reference StandardIn stock

Order Fingolimod EP Impurity I (CAS 249289-10-9) online at Zemixal: C21H35NO3, COA and SDS with every lot, worldwide shipping.

Pack sizes
Fingolimod EP Impurity I chemical structure
CAS number249289-10-9
FormulaC21H35NO3
Molar mass349.5 g/mol
Physical formSolid
HS code38229090
Purity96%
InChIKeyXDKYDMHKJNIXAT-UHFFFAOYSA-N
IUPAC nameN-[1-hydroxy-2-(hydroxymethyl)-4-(4-octylphenyl)butan-2-yl]acetamide

About Fingolimod EP Impurity I

Fingolimod EP Impurity I is supplied by Zemixal as a characterised reference material for Fingolimod analysis. Key data (Reference Standard): CAS 249289-10-9, formula C21H35NO3 and molar mass 349.5 g/mol. It is handled as a solid.

Typical applications

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

Handling and storage

Hazard communication follows GHS (Warning: H302 and H361). Our SDS lists exposure controls and first-aid measures.

Available as 10 mg, 25 mg, 50 mg, 100 mg and 250 mg. Larger or split packs can be arranged. Every shipment includes a certificate of analysis with characterisation data. Add it to your quote list and our team replies with price, lead time and shipping options within one business day.

Reference standards for Fingolimod

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

Fingolimod 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 Fingolimod EP Impurity I
Product nameFingolimod EP Impurity I
Catalogue numberZX-005712
CAS number249289-10-9
IUPAC nameN-[1-hydroxy-2-(hydroxymethyl)-4-(4-octylphenyl)butan-2-yl]acetamide
Molecular formulaC21H35NO3
Molar mass349.5 g/mol
Exact mass349.2617
GradeReference Standard
Purity / assay96%
Physical formSolid
XLogP34.4
H-bond donors / acceptors3 / 3
Topological polar surface area69.6 Ų
HS code38229090
InChIKeyXDKYDMHKJNIXAT-UHFFFAOYSA-N
SMILESCCCCCCCCC1=CC=C(C=C1)CCC(CO)(CO)NC(=O)C
PubChem CID10521783
SynonymsN-(1-Hydroxy-2-(hydroxymethyl)-4-(4-octylphenyl)butan-2-yl)acetamide, N-[1,1-Bis(hydroxymethyl)-3-(4-octylphenyl)propyl]acetamide, 2-[2-(4-n-Octylphenyl)ethyl]-2-acetamido-1,3-propanediol, Fingolimod Acetyl Amide Impurity, Acetamide, N-[1,1-bis(hydroxymethyl)-3-(4-octylphenyl)propyl]-, N-(1,1-Bis(hydroxymethyl)-3-(4-octylphenyl)propyl)acetamide, Fingolimod Impurity 11, N-(1,1-bis hydroxymethyl-3-(4-octyl phenyl)-propyl)-acetamide, N-[1,1-bis hydroxymethyl-3-(4-octyl phenyl)-propyl]-acetamide, Fingo A-2, Fingolimod Hydrochloride EP Impurity I, Fingolimod Impurity 26 (Fingolimod EP Impurity I)

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

Safety and GHS hazards

GHS07 Irritant or harmful
Irritant or harmful
GHS08 Health hazard
Health hazard

Signal word Warning

  • H302Harmful if swallowed
  • H361Suspected of damaging fertility or the unborn child

Precautionary statements P203, P264, P270, P280, P301 + P317, P318, P330, 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 Fingolimod EP Impurity I
10 mgQuoted on request
25 mgQuoted on request
50 mgQuoted on request
100 mgQuoted on request
250 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 Fingolimod EP Impurity I

Which CAS number identifies Fingolimod EP Impurity I?
Fingolimod EP Impurity I is registered under CAS 249289-10-9. You may also see it listed as N-(1-Hydroxy-2-(hydroxymethyl)-4-(4-octylphenyl)butan-2-yl)acetamide, N-[1,1-Bis(hydroxymethyl)-3-(4-octylphenyl)propyl]acetamide, 2-[2-(4-n-Octylphenyl)ethyl]-2-acetamido-1,3-propanediol. Our catalogue number for this item is ZX-005712.
What are the formula and molar mass of Fingolimod EP Impurity I?
For Fingolimod EP Impurity I, its formula is C21H35NO3 and its molar mass is 349.5 g/mol. The systematic (IUPAC) name is N-[1-hydroxy-2-(hydroxymethyl)-4-(4-octylphenyl)butan-2-yl]acetamide. InChIKey XDKYDMHKJNIXAT-UHFFFAOYSA-N lets you match it in any structure database.
How is Fingolimod EP Impurity I used in pharmaceutical QC?
Fingolimod EP Impurity I is a characterised reference material linked to Fingolimod. 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 Fingolimod EP Impurity I?
This listing is Reference Standard grade with 96% purity. Standard packs are 10 mg, 25 mg, 50 mg, 100 mg, 250 mg. Larger quantities and custom packing can be quoted on request.
Which documents come with Fingolimod 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 Fingolimod EP Impurity I to my country?
Yes. Because Fingolimod 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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