Duloxetine EP Impurity B

Name: Duloxetine EP Impurity B
Brand: Vaqora Chemicals
SKU: VQ-025436

About Duloxetine EP Impurity B

Listed under CAS 116539-55-0, Duloxetine EP Impurity B is a pharmacopeial impurity of Duloxetine available from Vaqora Chemicals. Its molecular formula is C8H13NOS and its molecular weight is 171.26 g/mol. Its systematic (IUPAC) name is (1S)-3-(methylamino)-1-thiophen-2-ylpropan-1-ol. Common synonyms include Duloxetine Hydrochloride - Impurity B and Duloxetine hydrochloride impurity B.

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. It carries the GHS signal word “Danger” with 3 hazard statements. Review the Safety Data Sheet before use.

As a characterised impurity of Duloxetine, it is used for analytical method development, method validation (AMV) and routine quality-control testing, and it supports ANDA and DMF regulatory filings. Our customers for this product work in pharmaceutical manufacturing and academic and industrial research.

Available in 10 mg, 25 mg, 50 mg and 100 mg packs, Duloxetine EP Impurity B is dispatched with a Certificate of Analysis (COA) to destinations worldwide.

Typical applications

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

Industries

Related to Duloxetine

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

Duloxetine impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Duloxetine EP Impurity B
Catalogue No.	VQ-025436
CAS Number	116539-55-0
IUPAC name	(1S)-3-(methylamino)-1-thiophen-2-ylpropan-1-ol
Molecular formula	C₈H₁₃NOS
Molecular weight	171.26 g/mol
Exact mass	171.0718
Grade	Reference Standard
HSN code	38229090
InChIKey	YEJVVFOJMOHFRL-ZETCQYMHSA-N
SMILES	CNCC[C@@H](C1=CC=CS1)O
PubChem CID	10095047

Physical properties
Physical form	Solid
LogP (XLogP3)	0.7
H-bond donors / acceptors	2 / 3
TPSA	60.5 Å²
Synonyms	Duloxetine Hydrochloride - Impurity B, (S)-(-)-3-(N-methylamino)-1-(2-thienyl)-1-propanol, (1S)-3-(methylamino)-1-(thiophen-2-yl)propan-1-ol, 3-(N-Methylamino)-1-(2-thienyl)-1-propanol, (-)-, (S)-(-)-3-methylamino-1-(2-thienyl)propan-1-ol, N-Methyl-(S)-(-)-3-hydroxy-3-(2-thiophen)propylamine, (1S)-(-)-3-(Methylamino)-1-(thien-2-yl)propan-1-ol, (S)-3-Methylamino-1-(thiophene-2-yl)propan-1-ol, 2-Thiophenemethanol, alpha-(2-(methylamino)ethyl)-, (alphaS)-, 2-Thiophenemethanol, alpha-[2-(methylamino)ethyl]-, (alphaS)-, Duloxetine hydrochloride impurity B, (S)-3-Methyl-amino-1-(2-thienyl)-1-propanol

Safety & hazard information (GHS)

Corrosive

Harmful / irritant

Signal word: Danger

Hazard statements

H302Harmful if swallowed
H314Causes severe skin burns and eye damage
H412Harmful to aquatic life with long lasting effects

Precautionary statements: P260, P264, P270, P273, P280, P301 + P317, P301 + P330 + P331, P302 + P361 + P354, P304 + P340, P305 + P354 + P338, P316, P321, P330, P363, 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 Duloxetine EP Impurity B?

The CAS Registry Number of Duloxetine EP Impurity B is 116539-55-0. It is also known as Duloxetine Hydrochloride - Impurity B, (S)-(-)-3-(N-methylamino)-1-(2-thienyl)-1-propanol, (1S)-3-(methylamino)-1-(thiophen-2-yl)propan-1-ol.

What is the molecular formula and molecular weight of Duloxetine EP Impurity B?

Duloxetine EP Impurity B has the molecular formula C8H13NOS and a molecular weight of 171.26 g/mol. Its IUPAC name is (1S)-3-(methylamino)-1-thiophen-2-ylpropan-1-ol.

What is Duloxetine EP Impurity B used for?

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

We supply Duloxetine EP Impurity B 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 Duloxetine EP Impurity B?

Yes. Every lot of Duloxetine EP Impurity B 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 Duloxetine EP Impurity B be shipped internationally?

Yes. Duloxetine EP Impurity B 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.