Fingolimod EP Impurity I

Name: Fingolimod EP Impurity I
Brand: Vaqora Chemicals
SKU: VQ-006391

About Fingolimod EP Impurity I

Fingolimod EP Impurity I (CAS 249289-10-9) is a pharmacopeial impurity of Fingolimod offered by Vaqora Chemicals with a typical assay of 96%. The compound has the formula C21H35NO3, corresponding to a molecular weight of 349.5 g/mol. Its systematic (IUPAC) name is N-[1-hydroxy-2-(hydroxymethyl)-4-(4-octylphenyl)butan-2-yl]acetamide. Alternative names: Fingolimod Acetyl Amide Impurity and Fingolimod Impurity 11.

The product is provided as a solid. Reference materials should be stored sealed and away from light and moisture, as specified on the accompanying COA. Under GHS it is labelled “Warning”, so handle it with suitable PPE and consult the SDS.

This Fingolimod impurity supports analytical method development and validation (AMV), batch release testing and the impurity sections of ANDA and DMF filings. Buyers come mainly from pharmaceutical manufacturing and academic and industrial research.

Vaqora Chemicals supplies Fingolimod 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. Stock is available for quick dispatch.

Typical applications

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

Industries

Related to Fingolimod

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

Fingolimod impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Fingolimod EP Impurity I
Catalogue No.	VQ-006391
CAS Number	249289-10-9
IUPAC name	N-[1-hydroxy-2-(hydroxymethyl)-4-(4-octylphenyl)butan-2-yl]acetamide
Molecular formula	C₂₁H₃₅NO₃
Molecular weight	349.5 g/mol
Exact mass	349.2617
Grade	Reference Standard
Purity / assay	96%
HSN code	38229090
InChIKey	XDKYDMHKJNIXAT-UHFFFAOYSA-N
SMILES	CCCCCCCCC1=CC=C(C=C1)CCC(CO)(CO)NC(=O)C
PubChem CID	10521783

Physical properties
Physical form	Solid
LogP (XLogP3)	4.4
H-bond donors / acceptors	3 / 3
TPSA	69.6 Å²
Synonyms	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, 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)

Safety & hazard information (GHS)

Harmful / irritant

Health hazard

Signal word: Warning

Hazard statements

H302Harmful if swallowed
H361Suspected of damaging fertility or the unborn child

Precautionary statements: P203, P264, P270, P280, P301 + P317, P318, P330, 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 Fingolimod EP Impurity I?

The CAS Registry Number of Fingolimod EP Impurity I is 249289-10-9. It is also known 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.

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

Fingolimod EP Impurity I has the molecular formula C21H35NO3 and a molecular weight of 349.5 g/mol. Its IUPAC name is N-[1-hydroxy-2-(hydroxymethyl)-4-(4-octylphenyl)butan-2-yl]acetamide.

What is Fingolimod EP Impurity I used for?

Fingolimod EP Impurity I is supplied as a characterised reference material related to Fingolimod. 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 Fingolimod EP Impurity I can I order?

We supply Fingolimod EP Impurity I in Reference Standard (96%) grade, in 10 mg, 25 mg, 50 mg, 100 mg, 250 mg packs. Larger bulk quantities and custom packing are quoted on request.

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

Yes. Every lot of Fingolimod 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 Fingolimod EP Impurity I be shipped internationally?

Yes. Fingolimod 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.