Pimecrolimus Impurity Standards
Pimecrolimus Impurity Standards
Pimecrolimus impurity reference standards are used by pharmaceutical quality-control laboratories, contract research organisations, and generic drug manufacturers to identify, quantify, and control Pimecrolimus-related impurities during analytical method development, method validation, and regulatory filing. As a calcineurin inhibitor, Pimecrolimus requires precise characterisation of its process impurities, degradation products, and related substances to meet European Pharmacopoeia (EP), United States Pharmacopeia (USP), and British Pharmacopoeia (BP) monograph requirements. Allmpus Laboratories manufactures and supplies a comprehensive library of Pimecrolimus impurity standards, each provided with a Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS). All products are held in-stock for rapid dispatch and are suitable for use in ANDA and DMF regulatory submissions.
PIMECROLIMUS TAUTOMER I
Chemical Name: (3S,4R,5S,8R,12S,14S,15R,16S,18R,26aS,E)...
CAS No:
N.A
Molecular Formula: C43H70ClNO12
Molecular Weight: 828.48
CAT No:
ALL-P04559
Keywords: SMILES string - O=C([C@@](CCCC1)([H])N1C...
Inventory Status:IN STOCK
PIMECROLIMUS TRINE ANALOG
Chemical Name: (3S,4R,5S,8R,12S,14S,15R,16S,18R,26aS,E)...
CAS No:
148147-41-5
Molecular Formula: C43H70ClNO12
Molecular Weight: 773.99 g/mol
CAT No:
ALL-P04586
Keywords: SMILES string - CO[C@@H]1[C@]([C@H](C[C...
Inventory Status:IN STOCK
27-ETHYL PIMECROLIMUS IMPURITY
Chemical Name: 1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25...
CAS No:
N.A
Molecular Formula: C44H70ClNO11
Molecular Weight: 824.48
CAT No:
ALL-P04579
Keywords: SMILES string - C/C([C@@H](OC([C@@H]1CC...
Inventory Status:IN STOCK
4-epi, 14,15-DEHYDRATE PIMICROLIMUS IMPURITY
Chemical Name: 15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazac...
CAS No:
161486-47-1
Molecular Formula: C43H66ClNO10
Molecular Weight: 792.4
CAT No:
ALL-P04563
Keywords: SMILES string - Cl[C@@H]1[C@H](OC)C[C@H...
Inventory Status:IN STOCK
DESCHLORO PIMECROLIMUS IMPURITY
Chemical Name: 15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazac...
CAS No:
137712-89-1
Molecular Formula: C43H67NO11
Molecular Weight: 776.01
CAT No:
ALL-P04562
Keywords: SMILES string - CO[C@@H]1[C@]([C@H](C[C@...
Inventory Status:IN STOCK
DESMETHYL PIMECROLIMUS IMPURITY
Chemical Name: (3S,4R,5S,8R,9E,12S,14...
CAS No:
1025113-89-6
Molecular Formula: C43H68ClNO11
Molecular Weight: 796.44
CAT No:
ALL-P04561
Keywords: SMILES string - CO[C@@H]1[C@]([C@H](C[C@...
Inventory Status:IN STOCK
ISO-PIMECROLIMUS
Chemical Name: (4R,5R,7S,8R,9S,11S,15R,18S,21R,E)-18-((...
CAS No:
N.A
Molecular Formula: C43H68ClNO11
Molecular Weight: 810.46
CAT No:
ALL-P04560
Keywords: SMILES string - Cl[C@@H]1[C@H](OC)C[C@H]...
Inventory Status:IN STOCK
OXA-COPE-CLAISEN-REARRANGEMENT-ASM IMPURITY
Chemical Name: Oxa-Cope-Claisen-rearrangement-ASM IMPUR...
CAS No:
N.A.
Molecular Formula: C43H68ClNO11
Molecular Weight: 810.45
CAT No:
ALL-PO6811
Keywords: OXA-COPE-CLAISEN-REARRANGEMENT-ASM IMP
Inventory Status:IN STOCK
OXA-COPE-CLAISEN-REARRANGEMENT-DEHYDRATE IMPURITY
Chemical Name: oxa-cope-claisen-rearrangement-dehydrate...
CAS No:
N.A.
Molecular Formula: C43H66ClNO10
Molecular Weight: 792.44
CAT No:
ALL-PO6610
Keywords: OXA-COPE-CLAISEN-REARRANGEMENT-DEHYDRAT
Inventory Status:IN STOCK
PIMECROLIMUS
Chemical Name: 15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazac...
CAS No:
137071-32-0
Molecular Formula: C43H68ClNO11
Molecular Weight: 810.45
CAT No:
ALL-P04540
Keywords: PIMECROLIMUS
Inventory Status:IN STOCK
PIMECROLIMUS 19-ETHYL-ASM IMPURITY
Chemical Name: Pimecrolimus 19-Ethyl-ASM Impurity
CAS No:
N.A.
Molecular Formula: C44H70ClNO11
Molecular Weight: 824.48
CAT No:
ALL-PO7011
Keywords: PIMECROLIMUS 19-ETHYL-ASM IMPURITY
Inventory Status:IN STOCK
PIMECROLIMUS 21-ETHYL-ASM IMPURITY
Chemical Name: Pimecrolimus 21-Ethyl-ASM Impurity
CAS No:
N.A.
Molecular Formula: C44H70ClNO11
Molecular Weight: 824.5
CAT No:
ALL-PO7111
Keywords: PIMECROLIMUS 21-ETHYL-ASM IMPURITY
Inventory Status:IN STOCK
PIMECROLIMUS TAUTOMER II
Chemical Name: (3S,4R,5S,8R,12S,14S,15R,16S,18R,19S,26a...
CAS No:
N.A
Molecular Formula: C43H68ClNO11
Molecular Weight: 810.46
CAT No:
ALL-P04558
Keywords: Pimecrolimus Tautomer II
Inventory Status:IN STOCK
Key Pimecrolimus Impurity Variants
- Pimecrolimus Tautomer I — a structural tautomer of pimecrolimus arising from keto-enol/hemiketal equilibria within the macrolactam ring, relevant to peak-purity and specificity studies
- Pimecrolimus Tautomer II — a second characterized tautomeric form used alongside Tautomer I for confirming chromatographic resolution of closely related species
- Desmethyl Pimecrolimus Impurity — an N- or O-demethylated analogue formed during synthesis, tracked as a process-related impurity
- Pimecrolimus Seco — Acid / Ring-Opened Degradant-a hydrolytic degradation product formed via macrolactone/macrolactam ring opening, relevant to forced-degradation and stability studies
- Ascomycin — Related Precursor Impurity-a starting-material or intermediate-derived impurity reflecting incomplete conversion in the semi-synthetic route from ascomycin
- Availability, CAS status, and characterization data (where assigned) vary by variant, and non-pharmacopeial or in-house-designated impurities are supplied alongside pharmacopeial reference materials on request.
Allmpus Capability for This Drug Family
Allmpus Laboratories has developed dedicated synthetic and isolation capability for ascomycin-family macrolactams, including pimecrolimus and its structurally related impurities and degradation products. Each compound is manufactured and isolated using preparative chromatographic and purification techniques suited to complex macrolactam structures, and is released with a comprehensive Certificate of Analysis comprising ¹H NMR, ¹³C NMR, mass spectrometry, HPLC, IR, and TGA data. This analytical package supports customers in confirming structure, purity, and identity for use in method validation, impurity qualification, and regulatory submission work. Allmpus's manufacturing and R&D operations, based in Maharashtra, India, operate under quality systems aligned with international regulatory expectations, supporting API manufacturers, generic drug developers, and contract research organizations sourcing pimecrolimus-related reference standards for QC and DMF/ANDA support work.
Frequently Asked Questions
What is the difference between a pharmacopeial and a non-pharmacopeial pimecrolimus impurity?
A pharmacopeial impurity is one formally listed and controlled in an EP or USP monograph with a defined limit, while a non-pharmacopeial impurity is identified during in-house method development, forced degradation, or process monitoring but is not (yet) named in a compendial monograph.
Why are tautomeric forms of pimecrolimus tracked as separate impurities?
Tautomers can co-elute with or closely trail the main peak in reversed-phase HPLC, so characterized tautomer standards are used to confirm method specificity and to ensure the tautomer is not mistaken for an unrelated degradation product.
What documentation is provided with pimecrolimus impurity standards?
Each standard is supplied with a Certificate of Analysis including spectroscopic (NMR, MS, IR) and chromatographic (HPLC) data, along with thermal analysis (TGA) where applicable, to support characterization and regulatory documentation requirements.