Alendronate sodium

Alendronate sodium: bisphosphonate.

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

Structure

Alendronate sodium: 2D structure drawn from the PubChem record (CID 23681107).

Compound data

CAS number

121268-17-5

Formula

C₄H₁₂NNaO₇P₂ · 3H₂O

Molecular weight

325.12 g/mol

Type

Bisphosphonate

Structure and names

Identity: Alendronate sodium trihydrate

IUPAC name: sodium;(4-amino-1-hydroxy-1-phosphonobutyl)-hydroxyphosphinate;trihydrate

How Vanguard tests Alendronate sodium

Method for the $250 identity, purity and quantity test: Chromatographic assay, with detection selected for the compound, against a reference standard, with results in 3 to 5 business days.

The USP monograph covers identity by infrared spectroscopy and a sodium test, assay by HPLC, organic impurities by HPLC, and loss on drying. Full testing to the USP Alendronate Sodium 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

Alendronate Sodium (CAS 121268-17-5)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Alendronate sodium testing

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

No. The $250 test covers identity, purity and quantity by a chromatographic assay, with detection selected for the compound. Full testing to the USP Alendronate Sodium monograph is available and quoted.

Why does the hydrate matter for the result?

USP alendronate sodium is the trihydrate, and the water makes up a sizable part of its weight. A result reported against the anhydrous acid will read differently, so the form is stated on the report.

Is alendronate hard to detect with a standard UV detector?

Yes. It has no aromatic ring and almost no UV absorbance, so the lab uses a detection method suited to the compound. The approach is confirmed before testing.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/23681107

Identity facts from the USP monograph header for this compound.

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