Pimecrolimus

Pimecrolimus: calcineurin inhibitor (ascomycin macrolactam).

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

Structure

Pimecrolimus: 2D structure drawn from the PubChem record (CID 6509979).

Compound data

CAS number

137071-32-0

Formula

C₄₃H₆₈ClNO₁₁

Molecular weight

810.46 g/mol

Type

Calcineurin inhibitor (ascomycin macrolactam)

Structure and names

Identity: Pimecrolimus

IUPAC name: (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(E)-1-[(1R,3R,4S)-4-chloro-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone

How Vanguard tests Pimecrolimus

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 HPLC retention time, assay by HPLC, organic impurities by HPLC, residue on ignition, water content, and optical rotation. Full testing to the USP Pimecrolimus 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

Pimecrolimus (CAS 137071-32-0)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Pimecrolimus 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 Pimecrolimus monograph is available and quoted.

What form does pimecrolimus usually arrive in?

Usually as a white powder or as a cream. Creams are extracted to separate pimecrolimus from the base before HPLC, and the result is reported as percent of label claim.

Can the test tell pimecrolimus from tacrolimus?

Yes. Pimecrolimus is a chlorinated ascomycin derivative, so it differs from tacrolimus in mass and in its chlorine content.

Does pimecrolimus absorb UV well?

No.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/6509979

Identity facts from the USP monograph header for this compound.

Order

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