Gemcitabine

About Gemcitabine

Gemcitabine is a high-purity reference standard of Gemcitabine carrying the CAS registry number 95058-81-4. The compound has the formula C9H11F2N3O4, corresponding to a molecular weight of 263.2 g/mol. The IUPAC name is 4-amino-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one. Common synonyms include 2'-Deoxy-2',2'-difluorocytidine and 2',2'-Difluorodeoxycytidine.

The product is provided as a solid. Keep the vial tightly closed, protected from light and humidity, at the temperature stated on the Certificate of Analysis. It carries the GHS signal word “Danger” with 12 hazard statements. Review the Safety Data Sheet before use.

Laboratories use this Gemcitabine standard for identity and assay testing, system suitability checks and method validation supporting ANDA and DMF filings. It is used across pharmaceutical manufacturing and academic and industrial research.

Available in 10 mg, 25 mg, 50 mg and 100 mg packs, Gemcitabine is dispatched with a Certificate of Analysis (COA) to destinations worldwide.

Typical applications

Identification & assay
Method development & validation
QC reference material

Industries

Related to Gemcitabine

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

Gemcitabine impurities

Specifications & identifiers

Chemical identifiers
Product name	Gemcitabine
Catalogue No.	VQ-030962
CAS Number	95058-81-4
IUPAC name	4-amino-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one
Molecular formula	C₉H₁₁F₂N₃O₄
Molecular weight	263.2 g/mol
Exact mass	263.0718
Grade	Reference Standard
HSN code	38229090
InChIKey	SDUQYLNIPVEERB-QPPQHZFASA-N
SMILES	C1=CN(C(=O)N=C1N)[C@H]2C([C@@H]([C@H](O2)CO)O)(F)F
PubChem CID	60750

Physical properties
Physical form	Solid
LogP (XLogP3)	-1.5
H-bond donors / acceptors	3 / 6
TPSA	108 Å²
Synonyms	2'-Deoxy-2',2'-difluorocytidine, 2',2'-Difluorodeoxycytidine, 2',2'-difluoro-2'-deoxycytidine, 2'deoxy-2',2'-difluorocytidine, gemicitabine, 4-amino-1-((2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl)pyrimidin-2-one, Hydrochloride, Gemcitabine, 2'-deoxy-2'-difluorocytidine, 2' Deoxy 2' Difluorocytidine, 1-(2-oxo-4-amino-1,2-dihydropyrimidin-1-yl)-2-deoxy-2,2-difluororibose, 2' Deoxy 2',2'' Difluorocytidine 5' O Monophosphate, 2',2'-DFDC

Safety & hazard information (GHS)

Harmful / irritant

Health hazard

Environmental hazard

Signal word: Danger

Hazard statements

H302Harmful if swallowed
H312Harmful in contact with skin
H315Causes skin irritation
H319Causes serious eye irritation
H335May cause respiratory irritation
H340May cause genetic defects
H351Suspected of causing cancer
H360May damage fertility or the unborn child
H361Suspected of damaging fertility or the unborn child
H372Causes damage to organs through prolonged or repeated exposure
H373May causes damage to organs through prolonged or repeated exposure
H411Toxic to aquatic life with long lasting effects

Precautionary statements: P203, P260, P261, P264, P264 + P265, P270, P271, P273, P280, P301 + P317, P302 + P352, P304 + P340, P305 + P351 + P338, P317, P318, P319, P321, P330, P332 + P317, P337 + P317, P362 + P364, P391, P403 + P233, P405

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 Gemcitabine?

The CAS Registry Number of Gemcitabine is 95058-81-4. It is also known as 2'-Deoxy-2',2'-difluorocytidine, 2',2'-Difluorodeoxycytidine, 2',2'-difluoro-2'-deoxycytidine.

What is the molecular formula and molecular weight of Gemcitabine?

Gemcitabine has the molecular formula C9H11F2N3O4 and a molecular weight of 263.2 g/mol. Its IUPAC name is 4-amino-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one.

What is Gemcitabine used for?

Gemcitabine is supplied as a characterised reference material related to Gemcitabine. 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 Gemcitabine can I order?

We supply Gemcitabine 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 Gemcitabine?

Yes. Every lot of Gemcitabine 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 Gemcitabine be shipped internationally?

Yes. Gemcitabine 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.