Description

Molgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF) analog, a critical biopharmaceutical agent used to stimulate the production of white blood cells. Its primary value lies in its therapeutic efficacy for managing neutropenia, a condition that significantly increases the risk of infection in patients undergoing chemotherapy or bone marrow transplantation. This product is essential for pharmaceutical manufacturers, research institutions, and clinical facilities focused on oncology, hematology, and advanced immunotherapy development.

Application

• Oncological Support Therapy: Primary application for the reduction in the duration of neutropenia and incidence of febrile neutropenia in patients receiving myelosuppressive anticancer drugs.
• Hematopoietic Stem Cell Transplantation: Used to mobilize peripheral blood progenitor cells (PBPCs) for collection and subsequent transplantation, and to accelerate neutrophil recovery post-transplant.
• Severe Chronic Neutropenia (SCN): Long-term administration for patients with congenital, cyclic, or idiopathic neutropenia to increase neutrophil counts and reduce infections.
• Research & Development: Serves as a key reference standard and active ingredient in bioassays, pharmacokinetic studies, and the development of biosimilar or novel biologic entities.
• Drug Formulation: Used by pharmaceutical companies in the formulation of injectable therapeutics, including lyophilized powders and pre-filled syringes.

Basic Information

Product Name	Molgrastim
CAS No.	99283-10-0
Molecular Formula	C845H1343N223O243S9
Molecular Weight	Approx. 18,800 Da
Synonyms	Pegfilgrastim; Recombinant Methionyl Human G-CSF; G-CSF analog; Filgrastim PEGylated; Neulasta (brand name reference); Granulocyte Colony-Stimulating Factor (PEGylated); PEG-r-metHuG-CSF; rG-CSF
EINECS	Contact for details

Quality Control

Our Molgrastim is manufactured under strict cGMP (current Good Manufacturing Practice) guidelines to ensure the highest standards of purity, potency, and consistency. Each batch is subjected to a comprehensive battery of analytical tests, including identity confirmation by peptide mapping and mass spectrometry, purity assessment by reverse-phase and size-exclusion HPLC, and rigorous testing for biological activity, endotoxins, and process-related impurities. A detailed Certificate of Analysis (COA) documenting compliance with relevant pharmacopeial standards (e.g., USP, EP) is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store unopened vials at 2-8°C. Do not freeze. Once reconstituted or diluted, use immediately or as directed by the appropriate pharmaceutical protocol. The product is hygroscopic (moisture-sensitive) and must be protected from exposure to high humidity.

Specification

Item	Specification
Appearance	White or off-white lyophilized powder or clear solution
Identification (Peptide Map)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0% Monomer
Purity (RP-HPLC)	≥ 95.0%
Assay (Biological Activity)	90% - 125% of labeled claim
Protein Content	90% - 110% of labeled claim
Endotoxin	< 1.0 EU/mg
Sterility	Sterile

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