Diphenhydramine EP Impurity A

About Diphenhydramine EP Impurity A

Diphenhydramine EP Impurity A is a pharmacopeial impurity of Diphenhydramine carrying the CAS registry number 53499-40-4. The compound has the formula C16H20ClNO, corresponding to a molecular weight of 277.79 g/mol. It is also known as Diphenhydramine EP Impurity A (HCl Salt) or Diphenhydramine Related Compound A.

It is supplied as a solid. Keep the vial tightly closed, protected from light and humidity, at the temperature stated on the Certificate of Analysis. The GHS classification uses the signal word “Danger”, so appropriate gloves, eye protection and ventilation are recommended.

This Diphenhydramine 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.

Available in 10 mg, 25 mg, 50 mg and 100 mg packs, Diphenhydramine EP Impurity A 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 Diphenhydramine

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

Diphenhydramine impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Diphenhydramine EP Impurity A
Catalogue No.	VQ-022405
CAS Number	53499-40-4
IUPAC name	2-benzhydryloxy-N-methylethanamine;hydrochloride
Molecular formula	C₁₆H₂₀ClNO
Molecular weight	277.79 g/mol
Exact mass	277.1233
Grade	Reference Standard
HSN code	38229090
InChIKey	OARUOQLHKTZEIM-UHFFFAOYSA-N
SMILES	CNCCOC(C1=CC=CC=C1)C2=CC=CC=C2.Cl
PubChem CID	45926626

Physical properties
Physical form	Solid
H-bond donors / acceptors	2 / 2
TPSA	21.3 Å²
Synonyms	Diphenhydramine EP Impurity A (HCl Salt), Diphenhydramine Related Compound A, Dimenhydrinate - Impurity F, Diphenhydramine - Impurity A, Diphenhydramine Related Compoud A, 2-(Benzhydryloxy)-N-methylethanamine hydrochloride, 2-(Diphenylmethoxy)-N-methylethanamine hydrochloride, N-DesMethyl DiphenhydraMine Hydrochloride, 2-(Benzhydryloxy)-N-methylethanamine HCl, Nordiphenhydramine Hydrochloride, 2-(Benzhydryloxy)-N-methylethanaminehydrochloride, 2-(Diphenylmethoxy)-N-methylethylamine Hydrochloride

Safety & hazard information (GHS)

Toxic

Harmful / irritant

Health hazard

Signal word: Danger

Hazard statements

H301Toxic if swallowed
H302Harmful if swallowed
H361Suspected of damaging fertility or the unborn child

Precautionary statements: P203, P264, P270, P280, P301 + P316, P301 + P317, P318, P321, 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 Diphenhydramine EP Impurity A?

The CAS Registry Number of Diphenhydramine EP Impurity A is 53499-40-4. It is also known as Diphenhydramine EP Impurity A (HCl Salt), Diphenhydramine Related Compound A, Dimenhydrinate - Impurity F.

What is the molecular formula and molecular weight of Diphenhydramine EP Impurity A?

Diphenhydramine EP Impurity A has the molecular formula C16H20ClNO and a molecular weight of 277.79 g/mol.

What is Diphenhydramine EP Impurity A used for?

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

We supply Diphenhydramine EP Impurity A 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 Diphenhydramine EP Impurity A?

Yes. Every lot of Diphenhydramine EP Impurity A 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 Diphenhydramine EP Impurity A be shipped internationally?

Yes. Diphenhydramine EP Impurity A 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.