Gemcitabine EP Impurity C

About Gemcitabine EP Impurity C

Gemcitabine EP Impurity C is a pharmacopeial impurity of Gemcitabine carrying the CAS registry number 114248-23-6. Its molecular formula is C9H10F2N2O5 and its molecular weight is 264.18 g/mol. Systematically, it is named 1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidine-2,4-dione. Common synonyms include Gemcitabine Hydrochloride - Impurity C and 2'-Deoxy-2',2'-difluorouridine.

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 10 hazard statements. Review the Safety Data Sheet before use.

As a characterised impurity of Gemcitabine, it is used for analytical method development, method validation (AMV) and routine quality-control testing, and it supports ANDA and DMF regulatory filings. Buyers come mainly from pharmaceutical manufacturing and academic and industrial research.

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and every batch ships with a Certificate of Analysis (COA) and we export worldwide.

Typical applications

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

Industries

Related to Gemcitabine

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

Gemcitabine impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Gemcitabine EP Impurity C
Catalogue No.	VQ-025970
CAS Number	114248-23-6
IUPAC name	1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidine-2,4-dione
Molecular formula	C₉H₁₀F₂N₂O₅
Molecular weight	264.18 g/mol
Exact mass	264.0558
Grade	Reference Standard
HSN code	38229090
InChIKey	FIRDBEQIJQERSE-QPPQHZFASA-N
SMILES	C1=CN(C(=O)NC1=O)[C@H]2C([C@@H]([C@H](O2)CO)O)(F)F
PubChem CID	9871558

Physical properties
Physical form	Solid
LogP (XLogP3)	-1.3
H-bond donors / acceptors	3 / 7
TPSA	99.1 Å²
Synonyms	Gemcitabine Hydrochloride - Impurity C, 2'-Deoxy-2',2'-difluorouridine, 2',2'-Difluorodeoxyuridine, Uridine, 2'-deoxy-2',2'-difluoro-, 2'-deoxy-2',2'-difluoro-d-uridine, Gemcitabine metabolite, Uridine,2'-deoxy-2',2'-difluoro-, 2Deoxy-22difluorouridine, 2'2'-Difluoro-2'-deoxyuridine, 2'-deoxy-2',2'-fluorouracil nucleoside, 1-(2-Deoxy-2,2-difluoro-beta-D-erythro-pentofuranosyl)pyrimidin-2,4(1H,3H)-dione

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
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
H411Toxic to aquatic life with long lasting effects

Precautionary statements: P203, P260, P264, P264 + P265, P270, P273, P280, P301 + P317, P302 + P352, P305 + P351 + P338, P317, P318, P319, P321, P330, P332 + P317, P337 + P317, P362 + P364, P391, 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 Gemcitabine EP Impurity C?

The CAS Registry Number of Gemcitabine EP Impurity C is 114248-23-6. It is also known as Gemcitabine Hydrochloride - Impurity C, 2'-Deoxy-2',2'-difluorouridine, 2',2'-Difluorodeoxyuridine.

What is the molecular formula and molecular weight of Gemcitabine EP Impurity C?

Gemcitabine EP Impurity C has the molecular formula C9H10F2N2O5 and a molecular weight of 264.18 g/mol. Its IUPAC name is 1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidine-2,4-dione.

What is Gemcitabine EP Impurity C used for?

Gemcitabine EP Impurity C 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 EP Impurity C can I order?

We supply Gemcitabine EP Impurity C 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 EP Impurity C?

Yes. Every lot of Gemcitabine EP Impurity C 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 EP Impurity C be shipped internationally?

Yes. Gemcitabine EP Impurity C 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.