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Pharmacopeial Impurities (EP / USP / BP)

Azelastine EP Impurity B

Reference StandardAvailable on request

Azelastine EP Impurity B (CAS 117078-69-0) supplier Zemixal. Lab and bulk packs, batch COA, fast global delivery. Catalogue no. ZX-020749.

Pack sizes
Azelastine EP Impurity B chemical structure
CAS number117078-69-0
FormulaC14H22ClN3O
Molar mass283.8 g/mol
Physical formSolid
HS code38229090
InChIKeyLBMOWZCEDIZQOM-UHFFFAOYSA-N
IUPAC nameN'-(1-methylazepan-4-yl)benzohydrazide;hydrochloride

About Azelastine EP Impurity B

Analytical teams working on Azelastine use Azelastine EP Impurity B as a qualified comparison standard. Identity at a glance (Reference Standard): CAS 117078-69-0, formula C14H22ClN3O and molar mass 283.8 g/mol. It is handled as a solid.

Common uses in the lab and plant

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

Storage and safety notes

It carries the GHS signal word Warning (H302), so wear gloves and eye protection and work with good ventilation.

Available as 10 mg, 25 mg, 50 mg and 100 mg. Larger or split packs can be arranged. You receive a certificate of analysis with characterisation data with each order. Add it to your quote list and our team replies with price, lead time and shipping options within one business day.

Reference standards for Azelastine

See every impurity, metabolite and related compound we list for this API.

Azelastine standards

Typical uses

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

Applications

Grade guides

Specifications and identifiers

Specifications of Azelastine EP Impurity B
Product nameAzelastine EP Impurity B
Catalogue numberZX-020749
CAS number117078-69-0
IUPAC nameN'-(1-methylazepan-4-yl)benzohydrazide;hydrochloride
Molecular formulaC14H22ClN3O
Molar mass283.8 g/mol
Exact mass283.1451
GradeReference Standard
Physical formSolid
H-bond donors / acceptors3 / 3
Topological polar surface area44.4 Ų
HS code38229090
InChIKeyLBMOWZCEDIZQOM-UHFFFAOYSA-N
SMILESCN1CCCC(CC1)NNC(=O)C2=CC=CC=C2.Cl
PubChem CID66524312
SynonymsAzelastine EP impurity B Hydrochloride, Azelastine EP Impurity B (HCl salt), 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, N`-(1-Methylazepan-4-yl)benzohydrazide Dihydrochloride

Lot values are stated on the batch certificate of analysis. Ask for a typical COA with your quotation.

Safety and GHS hazards

GHS07 Irritant or harmful
Irritant or harmful

Signal word Warning

  • H302Harmful if swallowed

Precautionary statements P264, P270, P301 + P317, P330, P501

Classification summarised from public GHS notifications. It can vary with grade and concentration, so always follow the SDS supplied with your lot.

Pack sizes

Pack sizes of Azelastine EP Impurity B
10 mgQuoted on request
25 mgQuoted on request
50 mgQuoted on request
100 mgQuoted on request

Need a different size? Bulk drums and custom packing are quoted on request through the quote form on this page.

Questions about Azelastine EP Impurity B

Which CAS number identifies Azelastine EP Impurity B?
Azelastine EP Impurity B is registered under CAS 117078-69-0. You may also see it listed as Azelastine EP impurity B Hydrochloride, Azelastine EP Impurity B (HCl salt), azelastine USP rc b. Our catalogue number for this item is ZX-020749.
What are the formula and molar mass of Azelastine EP Impurity B?
For Azelastine EP Impurity B, its formula is C14H22ClN3O and its molar mass is 283.8 g/mol. InChIKey LBMOWZCEDIZQOM-UHFFFAOYSA-N lets you match it in any structure database.
How is Azelastine EP Impurity B used in pharmaceutical QC?
Azelastine EP Impurity B is a characterised reference material linked to Azelastine. Laboratories use it to identify and quantify this impurity during method development and validation, stability work, batch release testing and regulatory submissions.
What grade and pack sizes are available for Azelastine EP Impurity B?
This listing is Reference Standard grade. Standard packs are 10 mg, 25 mg, 50 mg, 100 mg. Larger quantities and custom packing can be quoted on request.
Which documents come with Azelastine EP Impurity B?
Each lot ships with a batch certificate of analysis and a 16-section GHS safety data sheet. A typical COA or specification sheet can be shared with the quotation before you order.
Can Zemixal ship Azelastine EP Impurity B to my country?
Yes. Because Azelastine EP Impurity B is classed as hazardous, it travels in UN-approved packaging as dangerous goods under IATA or IMDG rules, with the export paperwork your broker needs.

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