General Information

Gemcitabine Impurities and Gemcitabine

Daicel Pharma specializes in synthesizing impurities for Gemcitabine, an active pharmaceutical ingredient. We offer impurities such as 1’-Epi Gemcitabine and 1’-Epi Gemcitabine Hydrochloride, which play a vital role in evaluating the purity and safety of Gemcitabine. Daicel Pharma also provides custom synthesis of Gemcitabine impurities to meet specific client needs and offer worldwide delivery options.

Gemcitabine [CAS: 95058-81-4] is a compound derived from 2′-deoxycytidine that contains fluorine atoms attached to the 2′-position. It treats breast cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer. Gemcitabine inhibits ribonucleotide reductase, which hinders DNA synthesis. It also acts as a prodrug and has been identified as an inhibitor of the enzyme EC 1.17.4.1.

Gemcitabine: Use and Commercial Availability  

Gemcitabine, available under Gemzar and Infugem, is a versatile chemotherapeutic agent used alone or in combination with other anticancer drugs. It finds application in various cancer treatments. In combination with [carboplatin], Gemcitabine treats advanced ovarian cancer that has relapsed at least six months after completing platinum-based therapy. For patients with metastatic breast cancer who have previously failed anthracycline-containing adjuvant chemotherapy, unless contraindicated, Gemcitabine in combination with [paclitaxel] serves as the first-line treatment option. In the case of non-small cell lung cancer (NSCLC), Gemcitabine, along with [cisplatin], is recommended as the first-line therapy for inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) cases. Gemcitabine and cisplatin treat Stage IV transitional cell carcinoma (TCC) of the bladder. Lastly, Gemcitabine is for patients who have previously been treated with fluorouracil.

Gemcitabine Structure and Mechanism of Action

The chemical name of Gemcitabine is 2′-Deoxy-2′, 2′-difluorocytidine. Its chemical formula is C₉H₁₁F₂N₃O₄, and its molecular weight is approximately 263.20 g/mol.

Gemcitabine kills cells undergoing DNA synthesis (S-phase). It inhibits ribonucleotide reductase for catalyzing the formation of deoxynucleoside triphosphates for DNA synthesis.

Gemcitabine Impurities and Synthesis

During the synthesis¹ of Gemcitabine, impurities may form. They can affect the purity, stability, and efficacy of Gemcitabine. Therefore, it is essential to control and minimize impurity levels during the synthetic process through stringent quality control measures. Efficient purification techniques, such as column chromatography and recrystallization, help remove impurities and ensure the production of high-quality Gemcitabine for therapeutic use.

Daicel Pharma, in adherence to cGMP standards, has a state-of-the-art analytical facility where we prepare Gemcitabine impurities like 1’-Epi Gemcitabine and 1’-Epi Gemcitabine Hydrochloride. We offer a comprehensive Certificate of Analysis (CoA) for these impurities, providing a detailed characterization report. The CoA includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². Upon request, we provide additional data like 13C-DEPT. We can synthesize unknown Gemcitabine impurities or degradation products. Each delivery has a comprehensive characterization report.