Benzonatate

Benzonatate: antitussive (aminobenzoate polyether ester).

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

Structure

Benzonatate: 2D structure drawn from the PubChem record (CID 7699).

Compound data

CAS number

104-31-4

Formula

C₃₀H₅₃NO₁₁

Molecular weight

603.74 g/mol

Type

Antitussive (aminobenzoate polyether ester)

Structure and names

Identity: Benzonatate

IUPAC name: 2-[2-[2-[2-[2-[2-[2-[2-(2-methoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethyl 4-(butylamino)benzoate

How Vanguard tests Benzonatate

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 and UV spectroscopy, assay by titration, refractive index, water content, residue on ignition, and chloride and sulfate limit tests. Full testing to the USP Benzonatate 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

Purity and quantity

$250

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

Raw powder purity

$200

Chromatographic purity on bulk powder. 50 mg.

Add-on tests

Add-on test	Price
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

Benzonatate (CAS 104-31-4)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Benzonatate 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 Benzonatate monograph is available and quoted.

Why is benzonatate's molecular weight given as an average?

Benzonatate is made with a polyethylene glycol type chain, so it contains a spread of chain lengths around the main nine-oxygen form. LC-MS shows this as a series of related masses rather than a single one.

What form does benzonatate arrive in?

It is a pale yellow, viscous liquid and is usually supplied in soft gel capsules. For capsules, the fill is removed and the result is reported per capsule.

Does the $250 test add a purity profile the monograph lacks?

Yes. The monograph has no chromatographic impurity test, so the HPLC run adds a purity profile alongside the quantity result.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/7699

Identity facts from the USP monograph header for this compound.

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