Cyclosporine Impurity Standards

Cyclosporine impurity reference standards are used by pharmaceutical quality-control laboratories, contract research organisations, and generic drug manufacturers to identify, quantify, and control Cyclosporine-related impurities during analytical method development, method validation, and regulatory filing. As a calcineurin inhibitor immunosuppressant, Cyclosporine 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 Cyclosporine 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.

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

CYCLOSPORIN AM1

Chemical Name: (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-3...

CAS No:
89270-28-0

Molecular Formula: C62H111N11O13

Molecular Weight: 1218.6

CAT No:
ALL-CO9131

Keywords: Cyclosporin AM 1

Inventory Status:DELIVERY IMMEDIATE

COA MSDS

CYCLOSPORIN AM19

Chemical Name: Cyclosporin Am19

CAS No:
N.A.

Molecular Formula: C62H111N11O14

Molecular Weight: 1234.63

CAT No:
ALL-CO9134

Keywords: Cyclosporin Am19

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

CYCLOSPORIN AM1c

Chemical Name: Cyclosporin Am1c

CAS No:
N.A.

Molecular Formula: C62H111N11O13

Molecular Weight: 1218.63

CAT No:
ALL-CO9135

Keywords: Cyclosporin Am1c

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

CYCLOSPORIN AM1c9

Chemical Name: Cyclosporin Am1c9

CAS No:
N.A.

Molecular Formula: C62H111N11O14

Molecular Weight: 1234.63

CAT No:
ALL-CO9136

Keywords: Cyclosporin Am1c9

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

CYCLOSPORIN AM4n

Chemical Name: (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-3...

CAS No:
89270-23-5

Molecular Formula: C61H109N11O12

Molecular Weight: 1188.6

CAT No:
ALL-CO9132

Keywords: SMILES string - O[C@@H]([C@](C(N[C@H](C(...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

CYCLOSPORIN AM9

Chemical Name: (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-3...

CAS No:
89270-25-7

Molecular Formula: C62H111N11O13

Molecular Weight: 1218.6

CAT No:
ALL-CO9133

Keywords: SMILES string -O[C@@H]([C@](C(N[C@H](C(N...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

CYCLOSPORIN A

Chemical Name: Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl...

CAS No:
59865-13-3

Molecular Formula: C62H111N11O12

Molecular Weight: 1202.61

CAT No:
ALL-C03383

Keywords: SMILES string - O[C@@H]([C@](C(N[C@H](C(...

Inventory Status:IN STOCK/76-1349

COA MSDS

CYCLOSPORIN A DIACETYL IMPURITY

Chemical Name: O-Acetyl Acetyloxy Cyclosporin A

CAS No:
138957-23-0

Molecular Formula: C66H115N11O15

Molecular Weight: 1302.68

CAT No:
ALL-A04047

Keywords: SMILES string - CCC1C(=O)N(CC(=O)N(C(C(=...

Inventory Status:IN STOCK/76-1598

COA MSDS

CYCLOSPORIN A O-ACETYL IMPURITY

Chemical Name: Cyclo[[(E)-(2S,3R,4R)-3-acetyloxy-4-meth...

CAS No:
83602-41-9

Molecular Formula: C64H113N11O13

Molecular Weight: 1244.65

CAT No:
ALL-A04048

Keywords: SMILES string - C[C@H](C/C=C/C)[C@H]([C@...

Inventory Status:IN STOCK/76-1597

COA MSDS

CYCLOSPORIN B

Chemical Name: Cyclo[L-alanyl-D-alanyl-N-methyl-L-leucy...

CAS No:
63775-95-1

Molecular Formula: C61H109N11O12

Molecular Weight: 1188.58

CAT No:
ALL-C04374

Keywords: SMILES string - O[C@@H]([C@](C(N[C@H](C(...

Inventory Status:IN STOCK/76-1352

COA MSDS

CYCLOSPORIN C

Chemical Name: Cyclo[L-alanyl-D-alanyl-N-methyl-L-leucy...

CAS No:
59787-61-0

Molecular Formula: C62H111N11O13

Molecular Weight: 1218.63

CAT No:
ALL-C04375

Keywords: SMILES string - O[C@@H]([C@](C(N[C@@](C(...

Inventory Status:IN STOCK/76-1353

COA MSDS

CYCLOSPORIN D / CYCLOSPORIN EP IMPURITY G

Chemical Name: Cyclo[L-alanyl-D-alanyl-N-methyl-L-leucy...

CAS No:
63775-96-2

Molecular Formula: C63H111N11O12

Molecular Weight: 1216.64

CAT No:
ALL-C04376

Keywords: SMILES string - O[C@@H]([C@](C(N[C@H](C(...

Inventory Status:IN STOCK/76-1354

COA MSDS

CYCLOSPORIN E

Chemical Name: (3S,6R,9S,12S,15S,18S,24S,27S,30S,33S)-2...

CAS No:
63798-73-2

Molecular Formula: C61H109N11O12

Molecular Weight: 1188.60

CAT No:
ALL-C08590

Keywords: SMILES string - CCC1C(=O)N(CC(=O)N(C(C(=...

Inventory Status:In Stock

COA MSDS

CYCLOSPORIN EP IMPURITY F

Chemical Name: 1,11-Anhydro[L-alanyl-D-alanyl-N-méthyl...

CAS No:
NA

Molecular Formula: C62H111N11O12

Molecular Weight: 1202.6

CAT No:
ALL-C08294

Keywords: SMILES string - CN(C([C@@H](C)NC(C(CC)NC...

Inventory Status:IN STOCK

COA MSDS

CYCLOSPORIN G

Chemical Name: (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-3...

CAS No:
74436-00-3

Molecular Formula: C63H113N11O12

Molecular Weight: 1216.64

CAT No:
ALL-C08520

Keywords: SMILES string - CC1CCC(OC1(C(=O)C(=O)N2C...

Inventory Status:IN STOCK

COA MSDS

CYCLOSPORIN H

Chemical Name: Cyclo[L-alanyl-D-alanyl-N-methyl-L-leucy...

CAS No:
83602-39-5

Molecular Formula: C62H111N11O12

Molecular Weight: 1202.64

CAT No:
ALL-C08519

Keywords: SMILES string - O[C@@H]([C@](C(N[C@H](C(...

Inventory Status:IN STOCK/76-1355

COA MSDS

CYCLOSPORIN IMPURITY A

Chemical Name: (1R,2R)-1-((2S,5S,11S,14S,17S,20S,23R,26...

CAS No:
121584-52-9

Molecular Formula: C62H109N11O14

Molecular Weight: 1232.6

CAT No:
ALL-C08984

Keywords: SMILES string - C[C@H](CC=O)[C@H]([C@](...

Inventory Status:DELIVERY IMMEDIATE

COA MSDS

CYCLOSPORIN L

Chemical Name: (E)-27-Ethyl-30-(1-hydroxy-2-methylhex-4...

CAS No:
108027-39-0

Molecular Formula: C61H109N11O12

Molecular Weight: 1188.6

CAT No:
ALL-C07390

Keywords: SMILES string - OC(C(C(NC(C(N(CC(N(C(C(N...

Inventory Status:IN STOCK

COA MSDS

CYCLOSPORIN U / CYCLOSPORIN EP IMPURITY D

Chemical Name: (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-3...

CAS No:
108027-45-8

Molecular Formula: C61H109N11O12

Molecular Weight: 1188.6

CAT No:
ALL-C08292

Keywords: SMILES string - O=C([C@H](C(C)C)N(C)C([C...

Inventory Status:IN STOCK

COA MSDS

CYCLOSPORINE IMPURITY E

Chemical Name: 1,11-Anhydro[acide D-alanyl-N-méthyl-L-...

CAS No:
108027-46-9

Molecular Formula: C63H113N11O12

Molecular Weight: 1216.7

CAT No:
ALL-C08293

Keywords: SMILES string - CC(C)C[C@H](N(C)C([C@H](...

Inventory Status:IN STOCK

COA MSDS

DIHYDROCYCLOSPORIN A / CYCLOSPORIN EP IMPURITY B

Chemical Name: 1,11-anhydro[l-alanyl-d-alanyl-N-methyl-...

CAS No:
59865-15-5

Molecular Formula: C62H113N11O12

Molecular Weight: 1204.63

CAT No:
ALL-C04183

Keywords: SMILES string - O[C@@H]([C@](C(N[C@H](C(...

Inventory Status:IN STOCK/76-1350

COA MSDS

ISOCYCLOSPORIN A

Chemical Name: ISOCYCLOSPORIN A

CAS No:
59865-16-6

Molecular Formula: C62H111N11O12

Molecular Weight: 1202.61

CAT No:
ALL-C04151

Keywords: Isocyclosporine

Inventory Status:IN STOCK/76-1351

COA MSDS

ISOCYCLOSPORIN H

Chemical Name: (2S,3R,4R,6E)-3-Hydroxy-4-methyl-2-(meth...

CAS No:
83602-43-1

Molecular Formula: C62H111N11O12

Molecular Weight: 1202.61

CAT No:
ALL-C04313

Keywords: SMILES string - C[C@H](C/C=C/C)[C@H]([C@...

Inventory Status:IN STOCK

COA MSDS

Key cyclosporin-related impurity variants available

Cyclosporin C (Ph. Eur. related substance; differs from cyclosporin A by a single threonine-for-alanine substitution)
Cyclosporin D (Ph. Eur. related substance; valine — for-alanine substitution relative to the parent molecule)
Dihydro — cyclosporin A (a reduced analog formed by saturation of the parent's characteristic double bond)
Iso — cyclosporin A (an isomerized form arising from an O→N acyl shift within the cyclic peptide backbone)
Cyclosporin H (Ph. Eur. related substance; D — configured amino acid variant of cyclosporin A)

Allmpus Capability for the Cyclosporin Family

Allmpus Laboratories supports synthesis and supply of complex cyclic-peptide and macrolide impurity standards, including compounds within the cyclosporin and related immunosuppressant families (such as tacrolimus-class impurities already listed in our catalogue). Our analytical chemistry group works with structural elucidation techniques (NMR, LC-MS) to confirm impurity identity prior to release, and our synthetic chemistry team is equipped to prepare low-abundance related substances and degradation products at milligram-to-gram scale for reference standard use. Each standard is supplied with supporting chemical name, molecular formula, and molecular weight data to assist laboratories in method qualification and regulatory submission work. Custom synthesis of additional cyclosporin-related impurities can be undertaken on request where a specific compendial or in-house impurity is not yet part of our standard catalogue.

Frequently Asked Questions

1. Why are cyclosporin-related substances difficult to control analytically?

Cyclosporin-related compounds are structurally similar cyclic peptides with closely matched polarity and mass, which can result in co-elution during standard reversed-phase HPLC unless the method has been specifically validated with authentic impurity reference standards.

2. Do EP and USP require the same named cyclosporin impurities?

The Ph. Eur. monograph for ciclosporin defines a set of lettered related substances (including Cyclosporin C, D, and H), while USP references related compounds under its own nomenclature; laboratories working across both markets should confirm which designation set applies to their specific submission.

3. Can Allmpus provide a cyclosporin impurity not currently listed in the catalogue?

Yes. Custom synthesis requests for additional cyclosporin-related substances or degradation products can be submitted through our enquiry form, and our R&D team will evaluate feasibility and turnaround time.