Diphenhydramine hydrochloride

Diphenhydramine hydrochloride: ethanolamine antihistamine.

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

Structure

2D structure of Diphenhydramine hydrochloride

Diphenhydramine hydrochloride: 2D structure drawn from the PubChem record (CID 8980).

Compound data

CAS number

147-24-0

Formula

C17H21NO · HCl

Molecular weight

291.82 g/mol

Type

Ethanolamine antihistamine

Structure and names

Identity: Diphenhydramine hydrochloride

IUPAC name: 2-benzhydryloxy-N,N-dimethylethanamine;hydrochloride

How Vanguard tests Diphenhydramine 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 Diphenhydramine Citrate monograph covers identity by infrared spectroscopy, HPLC retention time and a citrate test, assay by HPLC, organic impurities by HPLC, plus residue on ignition and loss on drying; the oral powder monograph uses HPLC with UV spectral matching for identity. Full testing to the USP Diphenhydramine 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

  • Diphenhydramine
  • Diphenhydramine Citrate (CAS 88637-37-0)
  • Diphenhydramine Hydrochloride (CAS 147-24-0)
  • Diphenhydramine Hydrochloride Oral Powder
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Diphenhydramine hydrochloride testing

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

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

What is the difference between diphenhydramine hydrochloride and citrate?

They are two salts of the same base. The citrate is much heavier, so a given amount of diphenhydramine base takes more citrate salt by weight. Tell us which salt the label claim refers to.

Can combination products be tested?

Yes. Diphenhydramine is often combined with pain relievers or decongestants, and HPLC separates it from those actives so each can be reported against its label claim.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/8980

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.