Salbutamol EP Impurity B

About Salbutamol EP Impurity B

Salbutamol EP Impurity B is a pharmacopeial impurity of Salbutamol carrying the CAS registry number 96948-64-0. Its molecular formula is C12H19NO2 and its molecular weight is 209.28 g/mol. Systematically, it is named 4-[2-(tert-butylamino)-1-hydroxyethyl]phenol. Alternative names: Salbutamol EP Impurity B (Free Base) and Levalbuterol Impurity B.

It is supplied as a solid. Store the standard in its sealed vial, protected from light and moisture, and follow the storage condition printed on the COA. It carries the GHS signal word “Warning” with 4 hazard statements. Review the Safety Data Sheet before use.

As a characterised impurity of Salbutamol, 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.

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and every batch ships with a Certificate of Analysis (COA) and we export worldwide.

Typical applications

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

Industries

Related to Salbutamol

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

Salbutamol impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Salbutamol EP Impurity B
Catalogue No.	VQ-023715
CAS Number	96948-64-0
IUPAC name	4-[2-(tert-butylamino)-1-hydroxyethyl]phenol
Molecular formula	C₁₂H₁₉NO₂
Molecular weight	209.28 g/mol
Exact mass	209.1416
Grade	Reference Standard
HSN code	38229090
InChIKey	JOGFUYPGDLRKHD-UHFFFAOYSA-N
SMILES	CC(C)(C)NCC(C1=CC=C(C=C1)O)O
PubChem CID	23844

Physical properties
Physical form	Solid
LogP (XLogP3)	0.4
H-bond donors / acceptors	3 / 3
TPSA	52.5 Å²
Synonyms	Salbutamol EP Impurity B (t-Butylnorsynephrine), Salbutamol EP Impurity B (Free Base), Levalbuterol Impurity B, Salbutamol Sulfate - Impurity B, t-Butylnorsynephrine, Kwd-2066, Kwd 2066, Benzenemethanol, alpha-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, Benzenemethanol, alpha-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, (+-)-, 4-(2-(tert-Butylamino)-1-hydroxyethyl)phenol, tert-Butylnorsynephrine, (1RS)-2-[(1,1-Dimethylethyl)amino]-1-(4-hydroxyphenyl)ethanol

Safety & hazard information (GHS)

Harmful / irritant

Signal word: Warning

Hazard statements

H302Harmful if swallowed
H315Causes skin irritation
H319Causes serious eye irritation
H335May cause respiratory irritation

Precautionary statements: P261, P264, P264 + P265, P270, P271, P280, P301 + P317, P302 + P352, P304 + P340, P305 + P351 + P338, 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 Salbutamol EP Impurity B?

The CAS Registry Number of Salbutamol EP Impurity B is 96948-64-0. It is also known as Salbutamol EP Impurity B (t-Butylnorsynephrine), Salbutamol EP Impurity B (Free Base), Levalbuterol Impurity B.

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

Salbutamol EP Impurity B has the molecular formula C12H19NO2 and a molecular weight of 209.28 g/mol. Its IUPAC name is 4-[2-(tert-butylamino)-1-hydroxyethyl]phenol.

What is Salbutamol EP Impurity B used for?

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

We supply Salbutamol 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 Salbutamol EP Impurity B?

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

Yes. Salbutamol 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.