Azelastine hydrochloride

Azelastine hydrochloride: antihistamine (H1 antagonist).

Azelastine hydrochloride testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.

Structure

2D structure of Azelastine hydrochloride

Azelastine hydrochloride: 2D structure drawn from the PubChem record (CID 54360).

Compound data

CAS number

79307-93-0

Formula

C22H24ClN3O · HCl

Molecular weight

418.36 g/mol

Type

Antihistamine (H1 antagonist)

Structure and names

Identity: Azelastine hydrochloride

IUPAC name: 4-[(4-chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1-one;hydrochloride

How Vanguard tests Azelastine hydrochloride

Method for the $250 identity, purity and quantity test: HPLC-UV purity and assay, LC-MS identity, against a reference standard, with results in 3 to 5 business days.

The USP monograph covers identity by infrared spectroscopy, HPLC retention time and a chloride test, assay by potentiometric titration, organic impurities by HPLC, residue on ignition, loss on drying and acidity or alkalinity. Full testing to the USP Azelastine Hydrochloride monograph is available and quoted.

What's reported

  • Purity, as percent of total peak area
  • Quantity, against the label claim
  • Identity, reported as match or no match against the reference standard
  • With monograph testing (quoted): the monograph’s tests against its limits

Tests and prices

$250

Chromatographic purity and mg per unit by the method matched to the compound, identity against a reference standard. 1 unit.

$200

Chromatographic purity on bulk powder. 50 mg.

Add-on tests

Add-on testPrice
Identity and impurities
FTIR identity$90
CHNS elemental analysis (carbon, hydrogen, nitrogen, sulfur)$125
Chiral purity (where a chiral method exists; new methods quoted)$250
Water, solvents and salt form
Water content by Karl Fischer$60
Residual solvents$150
Counterions: chloride, acetate and TFA$70
Assay
Assay, % w/w (with raw powder purity; $250 together)+$50
Metals and conformity
Heavy metals: arsenic, cadmium, chromium, mercury and lead$150
Conformity: purity and quantity on more units from the same lot$100 per extra unit
Microbiology (injectables)
Endotoxin$210
Sterility or bioburden$150
Container closure integrity (CCI)$50
Screening
Fentanyl screen$50

10% off for 10 or more samples.

Need something else? Other tests are available on request.

Sample amount and turnaround

Purity and quantity is $250 per sample (1 unit) and raw powder purity is $200 for 50 mg, with results in 3 to 5 business days. Send the material sealed and labeled, with the label claim and the form it contains.

Salts, forms and compendial references

  • Azelastine Hydrochloride (CAS 79307-93-0)
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Azelastine hydrochloride testing

Is the $250 test the same as USP monograph testing?

No. The $250 test covers identity, purity and quantity by HPLC with UV detection for purity and assay, and LC-MS for identity. Full testing to the USP Azelastine Hydrochloride monograph is available and quoted.

Can you test azelastine nasal sprays?

Yes. Nasal sprays are dilute solutions that also contain preservatives, and these separate from azelastine by HPLC. Send the label claim with the sample.

Is the result reported as the hydrochloride or the free base?

By default as azelastine hydrochloride, which is how most products are labeled. A free base value can be given on request.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/54360

Identity facts from the USP monograph header for this compound.

Order

Start an order online, or send the compound name and the tests you need for a quote.