Description

Pegnartograstim is a long-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF) analog designed to stimulate the production of neutrophils. This product is critical for managing chemotherapy-induced neutropenia, reducing the risk of infection and enabling timely treatment cycles. It is primarily required by pharmaceutical manufacturers, biotechnology companies, and clinical research organizations engaged in developing and producing advanced oncology therapeutics.

Application

• Oncology Supportive Care: Primary application for the prevention of severe neutropenia in patients undergoing myelosuppressive chemotherapy.
• Biosimilar Development: Serves as a key active pharmaceutical ingredient (API) for companies developing biosimilar versions of long-acting G-CSF therapies.
• Clinical Research: Used in preclinical and clinical studies investigating new regimens for hematopoietic support.
• Pharmaceutical Formulation: Essential raw material for the fill-finish manufacturing of injectable biologic drug products.
• Hematology Research: Tool for in vitro and in vivo studies of granulopoiesis and bone marrow function.

Basic Information

Product Name	Pegnartograstim
CAS No.	204565-76-4
Molecular Formula	C845H1343N223O243S9
Molecular Weight	Approx. 38,800 Da (monoisotopic)
Synonyms	PEGylated G-CSF; PEG-rhG-CSF; Pegfilgrastim (referring to the drug substance); Recombinant Methionyl Human G-CSF Conjugated to Monomethoxypolyethylene Glycol; Neulasta (Drug Product); G-CSF analog; Granulocyte Colony-Stimulating Factor, PEGylated; Long-acting filgrastim
EINECS	Contact for details

Quality Control

Our Pegnartograstim is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, potency, and safety, aligning with ICH Q6B guidelines for biotechnological products. A comprehensive Certificate of Analysis (COA) detailing tests for biological activity, purity by HPLC, endotoxin levels, and related substances is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store frozen at -20°C or below. This product is hygroscopic (moisture-sensitive). Allow to equilibrate to room temperature before opening to prevent condensation. For long-term storage, maintain the recommended frozen conditions.

Specification

Item	Specification
Appearance	White or off-white lyophilized powder or solid
Identification (HPLC)	Conforms to reference standard
Identification (Bioassay)	Conforms
Purity (SEC-HPLC)	≥ 98.0%
Related Substances (HPLC)	≤ 2.0% total
Potency (Cell-based assay)	90% - 110% of labeled claim
Protein Content	90% - 110% of theoretical
Endotoxin	< 1.0 EU/mg
Residual Moisture (KF)	≤ 3.0%

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