Simvastatin

Simvastatin: statin (HMG-CoA reductase inhibitor).

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

Structure

Simvastatin: 2D structure drawn from the PubChem record (CID 54454).

Compound data

CAS number

79902-63-9

Formula

C₂₅H₃₈O₅

Molecular weight

418.57 g/mol

Type

Statin (HMG-CoA reductase inhibitor)

Structure and names

Identity: Simvastatin

IUPAC name: [(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] 2,2-dimethylbutanoate

How Vanguard tests Simvastatin

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 and HPLC retention time, assay by HPLC, chromatographic purity by HPLC, specific rotation, loss on drying and residue on ignition. Full testing to the USP Simvastatin 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

Simvastatin (CAS 79902-63-9)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Simvastatin 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 Simvastatin monograph is available and quoted.

How is simvastatin told apart from lovastatin?

Simvastatin has one extra methyl group on its side chain, so it is 14 mass units heavier than lovastatin and elutes later by HPLC.

What degradation products are common?

Simvastatin is a lactone that can open to its hydroxy acid form, and it can oxidize. Both show up as separate peaks in the purity profile.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/54454

Identity facts from the USP monograph header for this compound.

Order

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