Voclosporin Impurity Standards

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

ISO VOCLOSPORIN VCSR016

Chemical Name: Iso Voclosporin (VCSR016)

CAS No:
N.A.

Molecular Formula: C63H111N11O12

Molecular Weight: 1214.65

CAT No:
ALL-V09386

Keywords: Iso Voclosporin (VCSR016)

Inventory Status:3-4 WEEK

COA MSDS

N-NITROSO ISO VOCLOSPORIN

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

CAS No:
N.A.

Molecular Formula: C63H110N12O13

Molecular Weight: 1243.64

CAT No:
ALL-V09387

Keywords: N-Nitroso Iso Voclosporin

Inventory Status:3-4 WEEK

COA MSDS

N-NITROSO VOCLOSPORIN

Chemical Name: N-Nitroso Voclosporin

CAS No:
N.A.

Molecular Formula: C63H110N12O13

Molecular Weight: 1243.64

CAT No:
ALL-V09406

Keywords: N-Nitroso Voclosporin

Inventory Status:3-4 WEEK

COA MSDS

VCSM004

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

CAS No:
N.A.

Molecular Formula: C65H113N11O13

Molecular Weight: 1256.66

CAT No:
ALL-C09258

Keywords: VCSM004

Inventory Status:3-4 WEEK

COA MSDS

VCSR013

Chemical Name: (3S,6S,9S,12S,15R,18S,21S,24S,27S,33S)-3...

CAS No:
N.A

Molecular Formula: C63H115N11O11

Molecular Weight: 1202.65

CAT No:
ALL-C09260

Keywords: VCSR013

Inventory Status:3-4 WEEK

COA MSDS

VCSR014

Chemical Name: (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-1...

CAS No:
N.A.

Molecular Formula: C62H109N11O12

Molecular Weight: 1200.62

CAT No:
ALL-C09262

Keywords: VCSR014

Inventory Status:3-4 WEEK

COA MSDS

VCSR023

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

CAS No:
N.A.

Molecular Formula: C63H109N11O11

Molecular Weight: 1196.61

CAT No:
ALL-C09261

Keywords: VCSR023

Inventory Status:3-4 WEEK

COA MSDS

VCSR037

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

CAS No:
N.A.

Molecular Formula: C64H113N11O12

Molecular Weight: 1228.67

CAT No:
ALL-C09266

Keywords: VCSR037

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN

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

CAS No:
515814-01-4

Molecular Formula: C63H111N11O12

Molecular Weight: 1214.65

CAT No:
ALL-V09393

Keywords: Smiles: O[C@@H]([C@](C(N[C@H](C(N(CC(N([...

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN H

Chemical Name: VOCLOSPORIN H

CAS No:
N.A.

Molecular Formula: C63H111N11O12

Molecular Weight: 1214.65

CAT No:
ALL-V09392

Keywords: VOCLOSPORIN H

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN IMPURITY 1

Chemical Name: Voclosporin Impurity 1

CAS No:
N.A.

Molecular Formula: C64H113N11O12

Molecular Weight: 1228.7

CAT No:
ALL-V09396

Keywords: Smiles: O=C([C@@H](C)NC([C@@H](NC([C@H](...

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN IMPURITY 10 VCSR008

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

CAS No:
N.A.

Molecular Formula: C63H109N11O11

Molecular Weight: 1196.63

CAT No:
ALL-C09264

Keywords: VOCLOSPORIN IMPURITY 10 VCSR008

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN IMPURITY 11 VCSR022 MIXTURE OF DIASTEREOMERS

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

CAS No:
N.A.

Molecular Formula: C63H111N11O12

Molecular Weight: 1214.65

CAT No:
ALL-C09265

Keywords: VOCLOSPORIN IMPURITY 11 VCSR022 MIXTURE ...

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN IMPURITY 12 VCSR058

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

CAS No:
N.A.

Molecular Formula: C69H119N11O12

Molecular Weight: 1294.78

CAT No:
ALL-C09267

Keywords: VOCLOSPORIN IMPURITY 12 (VCSR058)

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN IMPURITY 13

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

CAS No:
N.A.

Molecular Formula: C63H111N11O12

Molecular Weight: 1214.65

CAT No:
ALL-V09391

Keywords: Voclosporin Impurity 13

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN IMPURITY 2

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

CAS No:
N.A.

Molecular Formula: C63H111N11O13

Molecular Weight: 1230.65

CAT No:
ALL-V09397

Keywords: Smiles: CC(C)C[C@@H](C(N([C@@H](C(C)C)C(...

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN IMPURITY 3

Chemical Name: Voclosporin Impurity 3

CAS No:
N.A.

Molecular Formula: C63H113N11O14

Molecular Weight: 1248.66

CAT No:
ALL-V09398

Keywords: Voclosporin Impurity 3

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN IMPURITY 4

Chemical Name: Voclosporin Impurity 4

CAS No:
N.A.

Molecular Formula: C64H113N11O12

Molecular Weight: 1228.67

CAT No:
ALL-V09400

Keywords: Voclosporin Impurity 4

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN IMPURITY 5

Chemical Name: Voclosporin Impurity 5

CAS No:
N.A.

Molecular Formula: C64H113N11O12

Molecular Weight: 1228.67

CAT No:
ALL-V09401

Keywords: Voclosporin Impurity 5

Inventory Status:

COA MSDS

VOCLOSPORIN IMPURITY 6

Chemical Name: VOCLOSPORIN IMPURITY 6

CAS No:
N.A.

Molecular Formula: C64H113N11O12

Molecular Weight: 1228.67

CAT No:
ALL-V09394

Keywords: VOCLOSPORIN IMPURITY 6

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN IMPURITY 7

Chemical Name: Voclosporin Impurity 7

CAS No:
N.A.

Molecular Formula: C59H107N11O12

Molecular Weight: 1162.57

CAT No:
ALL-V09388

Keywords: Voclosporin Impurity 7

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN IMPURITY 8

Chemical Name: Voclosporin Impurity 8

CAS No:
N.A.

Molecular Formula: C60H109N11O12

Molecular Weight: 1176.60

CAT No:
ALL-V09389

Keywords: Voclosporin Impurity 8

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN IMPURITY 9

Chemical Name: Voclosporin Impurity 9

CAS No:
N.A.

Molecular Formula: C64H113N11O12

Molecular Weight: 1228.67

CAT No:
ALL-V09390

Keywords: Voclosporin Impurity 9

Inventory Status:3-4 WEEK

COA MSDS

VOCLOSPORIN Z-ISOMER

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

CAS No:
121584-34-7

Molecular Formula: C63H111N11O12

Molecular Weight: 1214.62

CAT No:
ALL-C09259

Keywords: Smiles: O[C@@H]([C@](C(N[C@H](C(N(CC(N([...

Inventory Status:3-4 WEEK

COA MSDS

Key Voclosporin Impurity Variants

Voclosporin Impurity 1 — a process-related impurity tracked in analytical impurity profiling of the drug substance
Voclosporin Impurity 6 — a structurally related process impurity used in method specificity studies
Voclosporin Impurity 11 (Mixture of Diastereomers) — a diastereomeric impurity arising from epimerization at an N-methylated residue during synthesis
Iso Voclosporin — an isomeric form of the parent molecule relevant to confirming resolution from the main peak in HPLC methods
Voclosporin Des — Hydroxy Impurity-a dehydroxylated analogue associated with synthetic side reactions and degradation pathways
Deuterated (D4) internal standard analogues and additional numbered process impurities are also available to support quantitative LC-MS/MS and metabolite-tracking work.

Allmpus's Capability for This Drug Family

Allmpus Laboratories manufactures and isolates voclosporin and its related structural impurities, drawing on synthetic capability developed across the broader cyclosporine-derived cyclic peptide class. Because voclosporin impurities frequently arise from stereochemical changes at specific amino acid residues within an undecapeptide ring, isolating and confirming these species requires preparative separation methods capable of resolving closely related diastereomers and isomers. Each compound supplied by Allmpus is released with a Certificate of Analysis comprising ¹H NMR, ¹³C NMR, mass spectrometry, HPLC purity, IR, and TGA data, supporting customers' method validation, impurity qualification, and regulatory documentation requirements. Allmpus's R&D and manufacturing operations, based in Maharashtra, India, support API manufacturers, formulation developers, and contract research organizations sourcing voclosporin-related reference standards for QC testing and regulatory filing support.

Frequently Asked Questions

Why doesn't voclosporin have EP or USP lettered impurities like older drugs?

Voclosporin received its first regulatory approval in 2021, so it has not yet been incorporated into a Ph. Eur. or USP monograph with formally lettered impurities; its related substances are currently tracked using manufacturer- and supplier-assigned impurity numbers.

Why are diastereomer and isomer impurities significant for voclosporin?

Voclosporin contains an N-methylated amino acid residue introduced during its semi-synthesis from cyclosporine A, and epimerization or E/Z isomerization at this site can generate closely related impurities that require careful chromatographic resolution to quantify accurately.

What documentation is provided with voclosporin 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.