Mitomycin Impurity Standards

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

7-HYDROXY MITOMYCIN

Chemical Name: ((1aS,8S,8aR,8bS)-6-hydroxy-8a-methoxy-5...

CAS No:
N.A.

Molecular Formula: C15H17N3O6 : C2H4O2

Molecular Weight: 335.3 : 60.1

CAT No:
ALL-MIT-4

Keywords: SMILES string -CO[C@]1([C@@H](N2)[C@@H]2...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

ALBOMITOMYCIN A

Chemical Name: ((1S,2S,4aS,8aR,9S,9aR)-7,9a-Dimethoxy-6...

CAS No:
N.A.

Molecular Formula: C16H19N3O6

Molecular Weight: 349.3

CAT No:
ALL-MIT-7

Keywords: SMILES string - NC(OC[C@H]([C@@]1([H])C(...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

CIS-1-HYDROXY-2,7-DIAMINO MITOSENE

Chemical Name: ((1S,2S)-2,7-diamino-1-hydroxy-6-methyl-...

CAS No:
98462-75-0

Molecular Formula: C14H16N4O5

Molecular Weight: 320.3

CAT No:
ALL-MIT-8

Keywords: SMILES string - O=C(C(C)=C(N)C1=O)C2=C1C...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

ISOOMITOMYCIN A

Chemical Name: ((2aR,2a1S,3S,7cS)-2a,5-Dimethoxy-6-meth...

CAS No:
91917-64-5

Molecular Formula: C16H19N3O6

Molecular Weight: 349.3

CAT No:
ALL-MIT-9

Keywords: SMILES string - CO[C@]12[C@@]3([H])N(C(C...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN

Chemical Name: [(1aS,8S,8aR,8bS)-6-Amino-8a-methoxy-5-m...

CAS No:
50-07-7

Molecular Formula: C15H18N4O5

Molecular Weight: 334.33

CAT No:
ALL-MIT-1

Keywords: SMILES string - O=C(C(N)=C1C)C2=C(N(C[C@...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN 3

Chemical Name: ((1aR,10S,10bR)-6,7-Dihydroxy-4,9-dioxo-...

CAS No:
N.A.

Molecular Formula: C16H18N4O6

Molecular Weight: 362.3

CAT No:
ALL-MIT-21

Keywords: SMILES string - O=C1C2=C([C@H](COC(N)=O)...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN EP IMPURITY A

Chemical Name: (E)-3-Phenylprop-2-enamide

CAS No:
621-79-4

Molecular Formula: C9H9NO

Molecular Weight: 147.17

CAT No:
ALL-MIT-2

Keywords: SMILES string - NC(/C=C/C1=CC=CC=C1)=O

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN EP IMPURITY B

Chemical Name: [(1aS,8S,8aR,8bS)-6,8a-Dimethoxy-5-methy...

CAS No:
4055-39-4

Molecular Formula: C16H19N3O6

Molecular Weight: 349.34

CAT No:
ALL-MIT-3

Keywords: SMILES string - O=C(C(OC)=C1C)C2=C(N(C[C...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN EP IMPURITY C

Chemical Name: [(1aS,8R,8aR,8bS)-8a-Hydroxy-6-methoxy-1...

CAS No:
4055-40-7

Molecular Formula: C16H19N3O6

Molecular Weight: 349.3

CAT No:
ALL-MIT-16

Keywords: SMILES string -O[C@]1([C@@H](N2C)[C@@H]2...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN EP IMPURITY D

Chemical Name: [(1S,2S,4S,5R,6S,6aR,10aS,11S)-8-Amino-5...

CAS No:
111750-67-5

Molecular Formula: C15H18N4O5

Molecular Weight: 334.3

CAT No:
ALL-MIT-17

Keywords: SMILES string - NC(OC[C@H]([C@@]1([H])C(...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN IMPURITY 1

Chemical Name: ((2S)-2,7-Diamino-1-((9-((carbamoyloxy)m...

CAS No:
N.A.

Molecular Formula: C29H32N8O9

Molecular Weight: 636.6

CAT No:
ALL-MIT-10

Keywords: SMILES string - O=C(C(N)=C1C)C2=C(N(C[C@...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN IMPURITY 2

Chemical Name: ((2S)-2,7-Diamino-1-((8-((carbamoyloxy)m...

CAS No:
N.A.

Molecular Formula: C29H32N8O9

Molecular Weight: 636.6

CAT No:
ALL-MIT-11

Keywords: SMILES string - O=C(C(N)=C1C)C2=C(N(C[C@...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN IMPURITY 3

Chemical Name: ((1R,2R)-2,7-Diamino-1-hydroxy-6-methyl-...

CAS No:
54911-19-2

Molecular Formula: C14H16N4O5

Molecular Weight: 320.3

CAT No:
ALL-MIT-12

Keywords: SMILES string -CC1=C(N)C(C2=C(N(C[C@@H](...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN IMPURITY 4

Chemical Name: ((1S,2R)-2,7-Diamino-1-methoxy-6-methyl-...

CAS No:
55253-25-3

Molecular Formula: C15H18N4O5

Molecular Weight: 334.3

CAT No:
ALL-MIT-13

Keywords: SMILES string -CC1=C(N)C(C2=C(N(C[C@@H](...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN IMPURITY 5

Chemical Name: ((1R,2R)-2,7-diamino-1-methoxy-6-methyl-...

CAS No:
55253-22-0

Molecular Formula: C15H18N4O5

Molecular Weight: 334.3

CAT No:
ALL-MIT-14

Keywords: SMILES string - CC1=C(N)C(C2=C(N(C[C@@H]...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN IMPURITY 6

Chemical Name: ((1S,2R)-2,7-diamino-1-hydroxy-6-methyl-...

CAS No:
54911-18-1

Molecular Formula: C14H16N4O5

Molecular Weight: 320.3

CAT No:
ALL-MIT-15

Keywords: SMILES string - CC1=C(N)C(C2=C(N(C[C@@H]...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN NITROSO IMPURITY 1

Chemical Name: ((1aS,8S,8aR,8bS)-6-Amino-8a-methoxy-5-m...

CAS No:
N.A.

Molecular Formula: C15H17N5O6

Molecular Weight: 363.3

CAT No:
ALL-MIT-20

Keywords: SMILES string - O=C(C(N)=C1C)C2=C(N(C[C@...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN RELATED COMPOUND 1

Chemical Name: ((1S,2S)-2,7-Diamino-1-hydroxy-6-methyl-...

CAS No:
N.A.

Molecular Formula: C14H16N4O5 : H2O

Molecular Weight: 320.3 : 18.0

CAT No:
ALL-MIT-6

Keywords: SMILES string -O=C(C(C)=C(N)C1=O)C2=C1C(...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN RELATED COMPOUND 2

Chemical Name: ((1R,2S)-2,7-Diamino-1-hydroxy-6-methyl-...

CAS No:
99745-88-7

Molecular Formula: C14H16N4O5

Molecular Weight: 320.3

CAT No:
ALL-MIT-5

Keywords: SMILES string - O=C(C(C)=C(N)C1=O)C2=C1C...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

MITOMYCIN-13C-D3

Chemical Name: ((1aS,8S,8aR,8bS)-6-Amino-8a-methoxy-5-(...

CAS No:
N.A.

Molecular Formula: C15H15N4O5D3

Molecular Weight: 338.3

CAT No:
ALL-MIT-19

Keywords: SMILES string - O=C(C(N)=C1[13C]([2H])([...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

[13C,15N2]-MITOMYCIN C

Chemical Name: ((1aS,8S,8aR,8bS)-6-(amino-15N)-8a-metho...

CAS No:
N.A.

Molecular Formula: C1413CH18N215N2O5

Molecular Weight: 337.3

CAT No:
ALL-MIT-18

Keywords: SMILES string -O=C(C([15NH2])=C1C)C2=C(N...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

Key Mitomycin Impurity Variants

Mitomycin EP Impurity A (Cinnamamide) — CAS 621-79-4, a process-related aromatic impurity used to establish method specificity in pharmacopeial assays
Mitomycin EP Impurity B (Mitomycin A) — CAS 4055-39-4, the 6-methoxy analog of Mitomycin C, one of the principal structurally related substances
Mitomycin Related Compound (Desmethyl/Demethoxy variant) — CAS 4055-40-7, formed via demethylation pathways relevant to degradation profiling
Mitomycin Process Impurity — CAS 7041-61-4, associated with synthetic intermediates in the mitosane pathway
Mitomycin Degradation — Related Standard-CAS 98462-75-0, used to support forced-degradation and stability-indicating method validation

Allmpus Capability for This Drug Family

Allmpus Laboratories supports the mitomycin impurity profile through its dedicated analytical and synthetic chemistry teams, working from R&D and manufacturing infrastructure that has received accreditation from USFDA, EU GMP, EDQM, KFDA, and COFEPRIS. Our synthesis groups are equipped to produce structurally complex, low-yield impurities such as those in the mitosane/azirino-pyrrolo-indole family, where aziridine ring stability and multi-step purification present specific synthetic challenges. Each standard is supported by structural characterization data (NMR, MS, HPLC purity) to enable direct use in method development, forced-degradation studies, and regulatory documentation. Custom synthesis is available for impurities not listed in our current catalogue, including isotopically labeled or nitrosamine-related variants where required for extended stability or genotoxicity assessment programs.

Frequently Asked Questions

Are Allmpus Mitomycin impurity standards supplied with a Certificate of Analysis and structural data?

Yes. Each standard is provided with a Certificate of Analysis and supporting analytical data (typically HPLC purity, NMR, and mass spectrometry) to allow direct use in method validation and regulatory filings.

Can Allmpus synthesize a Mitomycin-related impurity not currently listed in the catalogue?

Yes. Our synthetic and analytical chemistry teams undertake custom synthesis and scale-up of API impurities, including structurally complex targets within the mitosane class, on a case-by-case basis.

Are these standards intended for pharmaceutical QC use or research use only?

Allmpus impurity standards are supplied strictly for laboratory, research, and analytical use, including method development and stability-indicating assay validation. They are not intended for human consumption or clinical administration.