Cilastatin sodium

Cilastatin sodium: renal dehydropeptidase inhibitor.

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

Structure

2D structure of Cilastatin sodium

Cilastatin sodium: 2D structure drawn from the PubChem record (CID 23663403).

Compound data

CAS number

81129-83-1

Formula

C16H25N2NaO5S

Molecular weight

380.43 g/mol

Type

Renal dehydropeptidase inhibitor

Structure and names

Identity: Cilastatin sodium

IUPAC name: sodium (Z)-7-[(2R)-2-amino-2-carboxyethyl]sulfanyl-2-[[(1S)-2,2-dimethylcyclopropanecarbonyl]amino]hept-2-enoate

How Vanguard tests Cilastatin 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 HPLC retention time and a sodium flame test, assay by potentiometric titration, chromatographic purity by HPLC, residual solvents, and specific rotation, pH, water, bacterial endotoxins and sterility. Full testing to the USP Cilastatin 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

  • Cilastatin
  • Cilastatin Sodium (CAS 81129-83-1)
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Cilastatin 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 Cilastatin monograph is available and quoted.

Can cilastatin be tested in an imipenem and cilastatin product?

Yes. The two compounds separate by HPLC, so each can be quantified in the same run against its own reference standard and reported against the label claim.

Which isomer of cilastatin is the active form?

Cilastatin is the Z isomer of its double bond. The E isomer is a known related compound and appears as a separate peak in the HPLC purity profile.

Why is cilastatin hard to detect by UV?

Cilastatin has only a weak UV chromophore, so the lab uses a detection method suited to the compound.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/23663403

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.