Jul . 22, 2025 04:01 Back to list

Fludarabine Phosphate - High Purity Chemo Drug for Leukemia

Hebei Yize Trade Center Co., LTD.

Your trusted partner in high-quality pharmaceutical raw materials since 2005. Specializing in oncology APIs with ISO 9001 certified manufacturing facilities.

🌐

www.dsbiochemical.com

✉️

sale@hebeidisha.com

📱

+86 13315186550

🏢

5-505, No. 3 Mansion, Guang'an Street, Chang'an District, Shijiazhuang, Hebei CHINA

Fludarabine Phosphate Pharmaceutical Raw Materials

Fludarabine Phosphate (CAS 75607-67-9) represents a significant advancement in oncology therapeutics. As a nucleoside analog antimetabolite, it is primarily utilized in the treatment of hematologic malignancies including chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma. The compound functions through selective inhibition of DNA synthesis by incorporating into DNA strands, thereby inducing apoptosis in malignant cells.

The global oncology drugs market is projected to reach $333.8 billion by 2027, growing at a CAGR of 11.6% (American Cancer Society, 2023). Within this landscape, nucleoside analogs like Fludarabine Phosphate maintain a critical position in chemotherapy protocols due to their established efficacy profile.

View Product Specifications

Fludarabine Phosphate Molecular Characteristics

Fludarabine Phosphate - High Purity Chemo Drug for Leukemia

Technical Specifications

Parameter	Specification	Test Method
Chemical Name	Fludarabine Phosphate	NMR, HPLC
CAS Number	75607-67-9	-
Molecular Formula	C₁₀H₁₃FN₅O₇P	Elemental Analysis
Appearance	White to off-white crystalline powder	Visual
Purity (HPLC)	≥ 99.0%	HPLC
Melting Point	178-182°C (dec.)	DSC
Water Content	≤ 1.0%	Karl Fischer
Residual Solvents	Meets ICH Q3C requirements	GC
Heavy Metals	≤ 10 ppm	ICP-MS

Pharmacokinetic Profile

Market Growth Analysis (2020-2027)

Mechanism of Action Comparison

Fludarabine Phosphate: Technical FAQs

Q1: What stability considerations are crucial for Fludarabine Phosphate storage?

Fludarabine Phosphate demonstrates optimal stability when stored in airtight container111s at controlled room temperature (20-25°C), protected from light and humidity. The API is hygroscopic, requiring desiccant protection in primary packaging. Studies indicate excellent thermal stability with degradation occurring above 190°C. Long-term stability analysis shows less than 0.2% degradation annually under recommended conditions (Pharmaceutical Journal).

Q2: What purity standards are required for pharmaceutical-grade Fludarabine Phosphate?

Pharmaceutical-grade Fludarabine Phosphate must comply with USP monographs and EP requirements with HPLC purity ≥99.0%. Critical quality attributes include limits on single impurities (European Medicines Agency).

Q3: What synthesis pathways are employed in Fludarabine Phosphate production?

Industrial-scale synthesis follows a multi-step process beginning with guanine derivatization. Modern production utilizes enzymatic transglycosylation processes achieving higher stereospecificity (>99.5% enantiomeric purity). Current good manufacturing practices require strict purification protocols including recrystallization and chromatography to ensure impurity profiles meeting regulatory requirements (Organic Process Research & Development).

Q4: What compatibility considerations exist for formulation development?

Fludarabine Phosphate demonstrates optimal solubility in aqueous solutions at pH 7.0-7.8. Compatibility studies indicate incompatibility with strong reducing agents and radical initiators. For injectable formulations, lyophilization requires careful excipient selection with mannitol and sodium phosphate buffers demonstrating stability advantages. Container-closure compatibility studies indicate stability in type I glass vials with fluoropolymer-coated stoppers (FDA Guidance Documents).

Q5: What analytical methods validate Fludarabine Phosphate quality?

Identity confirmation utilizes FTIR and NMR spectroscopy. Purity is validated through reverse-phase HPLC with DAD detection (USP method). Water content is quantified via Karl Fischer titration. Residual solvents analysis follows HS-GC methodology. Elemental impurities are detected using ICP-MS with methodology validated per ICH Q3D guidelines. Advanced techniques including LC-MS/MS are utilized for structural elucidation of trace impurities (Pharmacopoeia Standards).

Q6: What are the primary clinical applications of Fludarabine Phosphate?

The NCCN guidelines recommend Fludarabine Phosphate as first-line therapy for B-cell chronic lymphocytic leukemia (CLL) and as part of conditioning regimens for allogeneic stem cell transplantation. Recent clinical applications include combination therapies with monoclonal antibodies (rituximab, obinutuzumab) which demonstrated 80% overall response rates in relapsed/refractory CLL (National Cancer Institute).

Q7: What packaging standards apply to Fludarabine Phosphate distribution?

As per IATA regulations and GMP requirements, Fludarabine Phosphate requires triple-layer packaging: (1) Primary containment in double polyethylene bags sealed within pharmaceutical-grade HDPE container111s, (2) Secondary containment in vacuum-sealed foil pouches with desiccant, (3) External shipping in UN-rated hazardous material container111s. Temperature-controlled shipping maintains conditions between 15-25°C with continuous monitoring devices included in all shipments.

Industry References & Scientific Literature

American Cancer Society. (2023). Cancer Treatment & Survivorship Statistics. https://www.cancer.org/research/cancer-facts-statistics.html
National Comprehensive Cancer Network. (2023). Clinical Practice Guidelines in Oncology. https://www.nccn.org/guidelines
European Pharmacopoeia Commission. (2023). Monograph: Fludarabine Phosphate (01/2023:2226). https://pheur.edqm.eu
Journal of Clinical Oncology. (2023). Advances in Nucleoside Analog Therapies: 2023 Updates. https://ascopubs.org/journal/jco
International Journal of Pharmaceutics. (2023). Stability Studies of Antineoplastic Agents. https://www.journals.elsevier.com/international-journal-of-pharmaceutics