Cyclosporin EP Impurity B

Name: Cyclosporin EP Impurity B
Brand: Vaqora Chemicals
SKU: VQ-025123

About Cyclosporin EP Impurity B

Listed under CAS 59865-15-5, Cyclosporin EP Impurity B is a pharmacopeial impurity of Cyclosporine available from Vaqora Chemicals. Formula C62H113N11O12, molecular weight 1204.6 g/mol. Alternative names: Cyclosporin Dihydro Impurity A and Cyclosporin A Dihydro Impurity.

It is supplied as a solid. Reference materials should be stored sealed and away from light and moisture, as specified on the accompanying COA. It carries the GHS signal word “Danger” with 3 hazard statements. Review the Safety Data Sheet before use.

Pharmaceutical QC and development laboratories use this impurity standard of Cyclosporine to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. Our customers for this product work in pharmaceutical manufacturing and academic and industrial research.

We offer Cyclosporin EP Impurity B in 10 mg, 25 mg, 50 mg and 100 mg packs with a batch-specific COA, and ship to customers worldwide.

Typical applications

Pharmacopeial method verification
Impurity profiling
QC release testing
ANDA / DMF filings

Industries

Related to Cyclosporine

View every impurity, metabolite and intermediate we list for Cyclosporine.

Cyclosporine impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Cyclosporin EP Impurity B
Catalogue No.	VQ-025123
CAS Number	59865-15-5
IUPAC name	(3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-ethyl-33-[(1R,2R)-1-hydroxy-2-methylhexyl]-1,4,7,10,12,15,19,25,28-nonamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-di(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecazacyclotritriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone
Molecular formula	C₆₂H₁₁₃N₁₁O₁₂
Molecular weight	1204.6 g/mol
Exact mass	1203.857
Grade	Reference Standard
HSN code	38229090
InChIKey	TYFOVYYNQGNDKH-HHPJSCBPSA-N
SMILES	CCCC[C@@H](C)[C@H]([C@H]1C(=O)N[C@H](C(=O)N(CC(=O)N([C@H](C(=O)N[C@H](C(=O)N([C@H](C(=O)N[C@H](C(=O)N[C@@H](C(=O)N([C@H](C(=O)N([C@H](C(=O)N([C@H](C(=O)N1C)C(C)C)C)CC(C)C)C)CC(C)C)C)C)C)CC(C)C)C)C(C)C)CC(C)C)C)C)CC)O
PubChem CID	25023708

Physical properties
Physical form	Solid
LogP (XLogP3)	8.2
H-bond donors / acceptors	5 / 12
TPSA	279 Å²
Synonyms	Cyclosporin Dihydro Impurity A, Cyclosporin A Dihydro Impurity, Cyclosporin - Impurity B, Cyclosporine Dihydro Impurity A, Dihydrocyclosporin A, Cyclosporin A, 6-((3R,4R)-3-hydroxy-N,4-dimethyl-L-2-aminooctanoic acid)-, Dihydro Cyclosporin A, Dihydrocyclosporine A, 6-[(2S,3R,4R)-3-Hydroxy-4-methyl-2-(methylamino)octanoic acid]cyclosporin A, 3eov, 2x2c, Cyclosporin A, dihydro-

Safety & hazard information (GHS)

Harmful / irritant

Health hazard

Signal word: Danger

Hazard statements

H302Harmful if swallowed
H350May cause cancer
H362May cause harm to breast-fed children

Precautionary statements: P203, P260, P263, P264, P270, P280, P301 + P317, P318, P330, P405, P501

Classification is indicative (aggregated GHS notifications) and may vary by grade and concentration. Always refer to the SDS supplied with your lot.

Documents

Safety Data Sheet (SDS)16-section GHS · on request Certificate of AnalysisTypical / batch COA · on request Specification sheetTDS / MOA · on request

Frequently asked questions

What is the CAS number of Cyclosporin EP Impurity B?

The CAS Registry Number of Cyclosporin EP Impurity B is 59865-15-5. It is also known as Cyclosporin Dihydro Impurity A, Cyclosporin A Dihydro Impurity, Cyclosporin - Impurity B.

What is the molecular formula and molecular weight of Cyclosporin EP Impurity B?

Cyclosporin EP Impurity B has the molecular formula C62H113N11O12 and a molecular weight of 1204.6 g/mol.

What is Cyclosporin EP Impurity B used for?

Cyclosporin EP Impurity B is supplied as a characterised reference material related to Cyclosporine. It is used for analytical method development and validation (AMV), impurity profiling, stability studies and quality control, and in ANDA/DMF regulatory filings.

Which grade and pack sizes of Cyclosporin EP Impurity B can I order?

We supply Cyclosporin EP Impurity B in Reference Standard grade, in 10 mg, 25 mg, 50 mg, 100 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Cyclosporin EP Impurity B?

Yes. Every lot of Cyclosporin EP Impurity B is shipped with a batch-specific Certificate of Analysis, and a 16-section GHS Safety Data Sheet is provided with the quotation and the shipment.

Can Cyclosporin EP Impurity B be shipped internationally?

Yes. Cyclosporin EP Impurity B is classified as hazardous, so it is packed in UN-approved packaging and shipped as dangerous goods under IATA/IMDG rules. We export worldwide on EXW, FOB, CIF and DAP terms.