Azelastine EP Impurity B

Name: Azelastine EP Impurity B
Brand: Vaqora Chemicals
SKU: VQ-021704

About Azelastine EP Impurity B

Listed under CAS 117078-69-0, Azelastine EP Impurity B is a pharmacopeial impurity of Azelastine available from Vaqora Chemicals. Formula C14H22ClN3O, molecular weight 283.8 g/mol. It is also known as Azelastine EP impurity B Hydrochloride or Azelastine EP Impurity B (HCl salt).

The product is provided as a solid. Store the standard in its sealed vial, protected from light and moisture, and follow the storage condition printed on the COA. The GHS classification uses the signal word “Warning”, so appropriate gloves, eye protection and ventilation are recommended.

This Azelastine impurity supports analytical method development and validation (AMV), batch release testing and the impurity sections of ANDA and DMF filings. It is used across 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 Azelastine

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

Azelastine impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Azelastine EP Impurity B
Catalogue No.	VQ-021704
CAS Number	117078-69-0
IUPAC name	N'-(1-methylazepan-4-yl)benzohydrazide;hydrochloride
Molecular formula	C₁₄H₂₂ClN₃O
Molecular weight	283.8 g/mol
Exact mass	283.1451
Grade	Reference Standard
HSN code	38229090
InChIKey	LBMOWZCEDIZQOM-UHFFFAOYSA-N
SMILES	CN1CCCC(CC1)NNC(=O)C2=CC=CC=C2.Cl
PubChem CID	66524312

Physical properties
Physical form	Solid
H-bond donors / acceptors	3 / 3
TPSA	44.4 Å²
Synonyms	Azelastine EP impurity B Hydrochloride, Azelastine EP Impurity B (HCl salt), Azelastine EP Impurity B, azelastine USP rc b, Azelastine - Impurity B (Hydrochloride Salt), Benzoic acid, 2-(hexahydro-1-methyl-1H-azepin-4-yl)hydrazide, hydrochloride (1:1), N'-(1-Methylazepan-4-yl)benzohydrazine, Benzoic Acid 2-(Hexahydro-1-methyl-1H-azepin-4-yl)hydrazide Hydrochloride, Azelastine HCl Impurity B, Benzoic acid, 2-(hexahydro-1-methyl-1H-azepin-4-yl)hydrazide, monohydrochloride, N'-(1-Methylazepan-4-yl)benzohydrazine Monohydrochloride Salt, N'-(1-methylazepan-4-yl)benzohydrazide:hydrochloride

Safety & hazard information (GHS)

Harmful / irritant

Signal word: Warning

Hazard statements

H302Harmful if swallowed

Precautionary statements: P264, P270, P301 + P317, P330, 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 Azelastine EP Impurity B?

The CAS Registry Number of Azelastine EP Impurity B is 117078-69-0. It is also known as Azelastine EP impurity B Hydrochloride, Azelastine EP Impurity B (HCl salt), Azelastine EP Impurity B.

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

Azelastine EP Impurity B has the molecular formula C14H22ClN3O and a molecular weight of 283.8 g/mol.

What is Azelastine EP Impurity B used for?

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

We supply Azelastine 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 Azelastine EP Impurity B?

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

Yes. Azelastine 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.