Description

Romiplostim is a recombinant fusion protein analog of thrombopoietin, functioning as a thrombopoiesis-stimulating Fc-peptide. This innovative therapeutic agent is specifically engineered to stimulate the production of platelets, addressing critical needs in hematology and oncology. It is primarily utilized in the biopharmaceutical industry for the development of targeted treatments for thrombocytopenia, particularly in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Application

• Active Pharmaceutical Ingredient (API): Core component in the formulation of injectable biologic drugs for the treatment of thrombocytopenia.
• Clinical Research & Development: Used in preclinical and clinical studies for novel therapies targeting platelet disorders.
• Hematology Therapeutics: Manufacture of treatments for chronic immune thrombocytopenia (ITP) to increase platelet counts.
• Oncology Supportive Care: Potential application in managing chemotherapy-induced thrombocytopenia.
• Biopharmaceutical Synthesis: Serves as a key recombinant protein in advanced biomanufacturing processes.
• Reference Standard: Used as a high-purity standard in analytical laboratories for quality control and method development.

Basic Information

Product Name	Romiplostim
CAS No.	267639-76-9
Molecular Formula	C2634H4086N722O790S20
Molecular Weight	~59 kDa
Synonyms	AMG 531; Nplate (Brand Name); Romiplostim-rkar; Thrombopoietin Peptide Mimetic; TPO Mimetic Peptide; Recombinant Thrombopoietin Receptor Agonist; Fc-Peptide Fusion Protein; Romiplostim (USAN); Romiplostimum
EINECS	Contact for details

Quality Control

Our Romiplostim is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, potency, and safety, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) is provided for every lot, confirming compliance with specified parameters for protein content, biological activity, purity by HPLC, and limits for endotoxins and process-related impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This product is hygroscopic (moisture-sensitive). For long-term storage, consider desiccated conditions. Avoid repeated freeze-thaw cycles.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0%
Purity (RP-HPLC)	≥ 95.0%
Assay (Protein Content)	90.0% - 110.0% of label claim
Biological Activity	Meets release criteria
Endotoxins	< 10 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.