Gemcitabine Hydrochloride Related Compounds & Impurities

Gemcitabine Hydrochloride is a nucleoside analogue antimetabolite that inhibits DNA synthesis, used for pancreatic, non-small cell lung, bladder and breast cancers.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Gemcitabine Hydrochloride reference standards, pharmacopeial and non-pharmacopeial Gemcitabine Hydrochloride impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Gemcitabine Hydrochloride-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Gemcitabine Hydrochloride
Gemcitabine Hydrochloride
  • CAT. No.G060000
  • CAS. No.122111-03-9
  • Mol. F.C9H12ClF2N3O4
  • Mol. W.299.66 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine EP Impurity A
Gemcitabine EP Impurity A
  • CAT. No.G060001
  • CAS. No.71-30-7
  • Mol. F.C4H5N3O
  • Mol. W.111.10 g/mol
  • Stock Status:Instock
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Gemcitabine EP Impurity C
Gemcitabine EP Impurity C
  • CAT. No.G060002
  • CAS. No.114248-23-6
  • Mol. F.C9H10F2N2O5
  • Mol. W.264.18 g/mol
  • Stock Status:Instock
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Gemcitabine EP Impurity B Hydrochloride
Gemcitabine EP Impurity B Hydrochloride
  • CAT. No.G060003
  • CAS. No.122111-05-1
  • Mol. F.C9H11F2N3O4.HCl
  • Mol. W.299.66 g/mol
  • Stock Status:Instock
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4-Hydroxy-3,4-dihydro-gemcitabine
4-Hydroxy-3,4-dihydro-gemcitabine
  • CAT. No.G060004
  • CAS. No.NA
  • Mol. F.C9H13F2N3O5
  • Mol. W.281.21 g/mol
  • Stock Status:Custom Synthesis
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1-(3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)6-hydroxydihydropyrimidine-2,4(1H,3H)-dione
1-(3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)6-hydroxydihydropyrimidine-2,4(1H,3H)-dione
  • CAT. No.G060005
  • CAS. No.NA
  • Mol. F.C9H12F2N2O6
  • Mol. W.282.20 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 4
Gemcitabine Impurity 4
  • CAT. No.G060006
  • CAS. No.294177-31-4
  • Mol. F.C9H10F2N2O5
  • Mol. W.264.19 g/mol
  • Stock Status:Custom Synthesis
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10-amino-5,5-difluoro-4-hydroxy-3,4,5,6,9,11a-hexahydro-3,6-epoxypyrimido[6,1-b][1,3]oxazocin-8(2H)-one
10-amino-5,5-difluoro-4-hydroxy-3,4,5,6,9,11a-hexahydro-3,6-epoxypyrimido[6,1-b][1,3]oxazocin-8(2H)-one
  • CAT. No.G060007
  • CAS. No.NA
  • Mol. F.C9H11F2N3O4
  • Mol. W.263.20 g/mol
  • Stock Status:Custom Synthesis
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2-Deoxy-2,2-difluoro-D-erythro-ribofuranose-3,5-dibenzoate 1-Methanesulfonate
2-Deoxy-2,2-difluoro-D-erythro-ribofuranose-3,5-dibenzoate 1-Methanesulfonate
  • CAT. No.G060008
  • CAS. No.122111-11-9
  • Mol. F.C20H18F2O8S
  • Mol. W.456.41 g/mol
  • Stock Status:Custom Synthesis
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2`-Deoxy-3`,5`-di-O-benzoyl-2`,2`-difluorocytidine
2`-Deoxy-3`,5`-di-O-benzoyl-2`,2`-difluorocytidine
  • CAT. No.G060009
  • CAS. No.134790-39-9
  • Mol. F.C23H19F2N3O6
  • Mol. W.471.49 g/mol
  • Stock Status:Custom Synthesis
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((2R,3R,5R)-3-(Benzoyloxy)-4,4-difluoro-5-((methylsulfonyl)oxy)tetrahydrofuran-2-yl)methyl benzoate
((2R,3R,5R)-3-(Benzoyloxy)-4,4-difluoro-5-((methylsulfonyl)oxy)tetrahydrofuran-2-yl)methyl benzoate
  • CAT. No.G060012
  • CAS. No.134877-42-2
  • Mol. F.C20H18F2O8S
  • Mol. W.456.41 g/mol
  • Stock Status:Instock
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3`-Epi Gemcitabine
3`-Epi Gemcitabine
  • CAT. No.G060013
  • CAS. No.103882-85-5
  • Mol. F.C9H11F2N3O4
  • Mol. W.263.20 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 9
Gemcitabine Impurity 9
  • CAT. No.G060014
  • CAS. No.122111-02-8
  • Mol. F.C19H14F2O6
  • Mol. W.376.31 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 10
Gemcitabine Impurity 10
  • CAT. No.G060015
  • CAS. No.1217452-91-9
  • Mol. F.C19H14F2O6
  • Mol. W.376.31 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine 5-benzoate
Gemcitabine 5-benzoate
  • CAT. No.G060016
  • CAS. No.2174019-90-8
  • Mol. F.C16H15F2N3O5
  • Mol. W.367.30 g/mol
  • Stock Status:Limited Stock
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Gemcitabine 3-benzoate
Gemcitabine 3-benzoate
  • CAT. No.G060017
  • CAS. No.1147182-15-7
  • Mol. F.C16H15F2N3O5
  • Mol. W.367.30 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine
Gemcitabine
  • CAT. No.G060018
  • CAS. No.95058-81-4
  • Mol. F.C9H11F2N3O4
  • Mol. W.263.20 g/mol
  • Stock Status:Instock
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(3R,4R)-1-ethoxy-2,2-difluoro-4,5-dihydroxy-1-oxopentan-3-yl benzoate
(3R,4R)-1-ethoxy-2,2-difluoro-4,5-dihydroxy-1-oxopentan-3-yl benzoate
  • CAT. No.G060020
  • CAS. No.NA
  • Mol. F.C14H16F2O6
  • Mol. W.318.27 g/mol
  • Stock Status:Custom Synthesis
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(R)-1-((R)-2,2-dimethyl-1,3-dioxolan-4-yl)-3-ethoxy-2,2-difluoro-3-oxopropyl benzoate
(R)-1-((R)-2,2-dimethyl-1,3-dioxolan-4-yl)-3-ethoxy-2,2-difluoro-3-oxopropyl benzoate
  • CAT. No.G060021
  • CAS. No.NA
  • Mol. F.C17H20F2O6
  • Mol. W.358.33 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 15
Gemcitabine Impurity 15
  • CAT. No.G060022
  • CAS. No.95058-92-7
  • Mol. F.C10H16F2O5
  • Mol. W.254.23 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 21
Gemcitabine Impurity 21
  • CAT. No.G060023
  • CAS. No.122111-07-3
  • Mol. F.C12H10F2O5
  • Mol. W.272.20 g/mol
  • Stock Status:Custom Synthesis
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(R)-Glyceraldehyde acetonide
(R)-Glyceraldehyde acetonide
  • CAT. No.G060024
  • CAS. No.15186-48-8
  • Mol. F.C6H10O3
  • Mol. W.130.14 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 11
Gemcitabine Impurity 11
  • CAT. No.G060025
  • CAS. No.122111-01-7
  • Mol. F.C19H14F2O6
  • Mol. W.376.31 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 19
Gemcitabine Impurity 19
  • CAT. No.G060027
  • CAS. No.95058-77-8
  • Mol. F.C5H6F2O4
  • Mol. W.168.10 g/mol
  • Stock Status:Custom Synthesis
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2-Deoxy-2,2-difluoro-D-erythro-pentofuranose
2-Deoxy-2,2-difluoro-D-erythro-pentofuranose
  • CAT. No.G060028
  • CAS. No.861445-88-7
  • Mol. F.C5H8F2O4
  • Mol. W.170.11 g/mol
  • Stock Status:Custom Synthesis
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3,3,difluoro 4- hydroxy-5-(hydroxyl methyl) dihydrofuran-2(3H)-one
3,3,difluoro 4- hydroxy-5-(hydroxyl methyl) dihydrofuran-2(3H)-one
  • CAT. No.G060029
  • CAS. No.939760-77-7
  • Mol. F.C5H6F2O4
  • Mol. W.168.10 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 12
Gemcitabine Impurity 12
  • CAT. No.G060030
  • CAS. No.143157-22-6
  • Mol. F.C19H16F2O6
  • Mol. W.378.32 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 29
Gemcitabine Impurity 29
  • CAT. No.G060031
  • CAS. No.153381-14-7
  • Mol. F.C9H10F2N2O5
  • Mol. W.264.18 g/mol
  • Stock Status:Custom Synthesis
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1`-Epi Gemcitabine 3`,5`-Dibenzoate
1`-Epi Gemcitabine 3`,5`-Dibenzoate
  • CAT. No.G060032
  • CAS. No.134790-40-2
  • Mol. F.C23H19F2N3O6
  • Mol. W.471.42 g/mol
  • Stock Status:Custom Synthesis
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3`-Epi Gemcitabine 3`,5`-Dibenzoate
3`-Epi Gemcitabine 3`,5`-Dibenzoate
  • CAT. No.G060033
  • CAS. No.1268237-46-2
  • Mol. F.C23H19F2N3O6
  • Mol. W.471.41 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 31
Gemcitabine Impurity 31
  • CAT. No.G060035
  • CAS. No.122111-12-0
  • Mol. F.C5H6F2O4
  • Mol. W.168.10 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine EP Impurity B
Gemcitabine EP Impurity B
  • CAT. No.G060036
  • CAS. No.95058-85-8
  • Mol. F.C9H11F2N3O4
  • Mol. W.263.20 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 35 Hydrochloride
Gemcitabine Impurity 35 Hydrochloride
  • CAT. No.G060037
  • CAS. No.NA
  • Mol. F.C9H11F2N3O4.HCl
  • Mol. W.299.66 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 1
Gemcitabine Impurity 1
  • CAT. No.G060039
  • CAS. No.1155863-81-2
  • Mol. F.C23H19F2N3O6
  • Mol. W.471.41 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 5
Gemcitabine Impurity 5
  • CAT. No.G060040
  • CAS. No.NA
  • Mol. F.C16H18O4
  • Mol. W.273.21 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 6
Gemcitabine Impurity 6
  • CAT. No.G060041
  • CAS. No.1173824-58-2
  • Mol. F.C19H16F2O6
  • Mol. W.378.32 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine Impurity 2
Gemcitabine Impurity 2
  • CAT. No.G060042
  • CAS. No.166376-98-3
  • Mol. F.C10H16F2O5
  • Mol. W.254.20 g/mol
  • Stock Status:Custom Synthesis
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Metabolites

Gemcitabine triphosphate
Gemcitabine triphosphate
  • CAT. No.G060034
  • CAS. No.110988-86-8
  • Mol. F.C9H14F2N3O13P3
  • Mol. W.503.14 g/mol
  • Stock Status:Custom Synthesis
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Isotope Labelled Compounds

Gemcitabine-13C-15N2
Gemcitabine-13C-15N2
  • CAT. No.G060019
  • CAS. No.1233921-74-8
  • Mol. F.C813CH11F2N15N2O4
  • Mol. W.266.18 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine EP Impurity C-13C,15N2
Gemcitabine EP Impurity C-13C,15N2
  • CAT. No.G060026
  • CAS. No.1233921-75-9
  • Mol. F.C813CH10F215N2O5
  • Mol. W.267.16 g/mol
  • Stock Status:Custom Synthesis
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Gemcitabine 13C,15N2 Hydrochloride
Gemcitabine 13C,15N2 Hydrochloride
  • CAT. No.G060038
  • CAS. No.1262897-74-4
  • Mol. F.C813CH11F2N15N2O4.HCl
  • Mol. W.302.64 g/mol
  • Stock Status:Custom Synthesis
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