Description

Filgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF) analog, a critical therapeutic protein used to stimulate the production of white blood cells. Its primary value lies in its ability to reduce the risk of infection in patients undergoing myelosuppressive treatments, such as chemotherapy. This product is essential for pharmaceutical manufacturers, research institutions, and biotechnology companies developing biosimilars, novel drug formulations, and advanced cell therapies. We supply high-purity Filgrastim CAS NO 121181-53-1 to support the global healthcare industry's demand for reliable and effective active pharmaceutical ingredients (APIs).

Application

• Oncology Supportive Care: Primary application for the management of chemotherapy-induced neutropenia to prevent febrile neutropenia and associated infections.
• Biosimilar Development: Serves as the reference or active ingredient for companies developing and manufacturing biosimilar versions of G-CSF therapies.
• Hematopoietic Stem Cell Transplantation: Used to mobilize peripheral blood progenitor cells (PBPCs) for collection prior to transplantation.
• Severe Chronic Neutropenia (SCN): Treatment for patients with congenital, cyclic, or idiopathic neutropenia to increase neutrophil counts and reduce infections.
• Pharmaceutical Research: Critical reagent in preclinical and clinical research studying hematopoiesis, immune response, and bone marrow function.
• Drug Formulation: Used in the development of various dosage forms, including lyophilized powders and pre-filled syringe solutions.

Basic Information

Item	Detail
Product Name	Filgrastim
CAS No.	121181-53-1
Molecular Formula	C845H1343N223O243S9
Molecular Weight	Approx. 18,800 Da
Synonyms	Recombinant Human G-CSF; Granulocyte Colony-Stimulating Factor; G-CSF; r-metHuG-CSF; Neupogen® (Brand Name); Filgrastim-aafi; Tbo-filgrastim; Granulocyte-Stimulating Factor; Myeloid Growth Factor; Colony Stimulating Factor 3 (CSF 3)
EINECS	Contact for details

Quality Control

Our Filgrastim is manufactured and tested under strict quality systems. Each batch is characterized to ensure identity, purity, potency, and safety, aligning with ICH Q6B guidelines for biotechnological products. We provide comprehensive Certificates of Analysis (COA) detailing specifications for purity by HPLC, biological activity, endotoxin levels, and related proteins. The product is suitable for use in GMP-compliant pharmaceutical manufacturing and advanced research applications.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized powder at 2-8°C. Reconstituted solutions should be used immediately or stored as directed. This product is hygroscopic (moisture-sensitive) and must be protected from humidity.

Specification

Item	Specification
Appearance	White or off-white lyophilized powder
Identification (HPLC/MS)	Conforms to reference standard
Purity (RP-HPLC)	≥ 98.0%
Biological Activity	≥ 1.0 x 108 IU/mg
Endotoxin	< 10 EU/mg
Related Proteins (HPLC)	≤ 2.0%
Moisture Content (KF)	≤ 3.0%
Sterility (Membrane Filtration)	Sterile

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.