Description

Rituximab is a chimeric monoclonal antibody specifically targeting the CD20 antigen expressed on the surface of B lymphocytes. This targeted therapeutic action is critical for the treatment of specific B-cell malignancies and autoimmune disorders. It is an essential active pharmaceutical ingredient (API) for the formulation of injectable biopharmaceuticals. Global pharmaceutical manufacturers and advanced research institutions rely on a consistent, high-quality supply of this biologic for drug development and production.

Application

• Oncologic Therapeutics: Primary API for the manufacture of targeted therapies for non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), and other CD20-positive B-cell malignancies.
• Autoimmune Disease Treatment: Used in formulations for managing autoimmune conditions such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.
• Biosimilar Development: Serves as the reference molecule for the research, development, and analytical characterization of biosimilar products.
• Clinical Research: Employed as a critical reagent in preclinical and clinical studies investigating B-cell mediated diseases and novel combination therapies.
• Pharmaceutical Manufacturing: The core biologic component in aseptic fill-finish processes for producing final dosage forms (lyophilized powder or solution for infusion).

Basic Information

Item	Detail
Product Name	Rituximab
CAS No.	174722-31-7
Molecular Formula	C6416H9874N1688O1987S44
Molecular Weight	Approx. 145 kDa
Synonyms	Rituxan; MabThera; IDEC-C2B8; Anti-CD20 Monoclonal Antibody; Chimeric Anti-CD20 IgG1; C2B8 Monoclonal Antibody; Rituximab-abbs; Rituximab-pvvr
EINECS	Contact for details

Quality Control

Our Rituximab is manufactured and controlled under a quality management system compliant with cGMP guidelines for active pharmaceutical ingredients (APIs). Each batch undergoes comprehensive analytical testing including potency, purity, identity, and safety assays. A detailed Certificate of Analysis (COA) is provided, documenting results for critical quality attributes such as biological activity, protein concentration, aggregate content, and endotoxin levels to ensure compliance with pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized powder at 2-8°C. Reconstituted or liquid formulations should be handled according to the specific product instructions, typically requiring storage at 2-8°C and protection from freezing. Maintain the cold chain during transport.

Specification

Item	Specification
Appearance	White to off-white lyophilized cake or clear to slightly opalescent solution
Identification (HPLC/CE-SDS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0% Monomer
Potency (Cell-based Bioassay)	90.0% - 115.0% of labeled activity
Protein Content (A280)	90.0% - 110.0% of label claim
pH	6.0 - 7.0 (in solution)
Endotoxins (LAL)	< 1.0 EU/mg
Sterility (Membrane Filtration)	Sterile

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