Description

Omalizumab is a recombinant DNA-derived humanized monoclonal antibody that selectively binds to immunoglobulin E (IgE). This product is a critical active pharmaceutical ingredient (API) used in the formulation of targeted biologic therapies. It is essential for pharmaceutical manufacturers and research institutions developing treatments for allergic asthma and chronic idiopathic urticaria. Our supply of Omalizumab CAS NO 242138-07-4 ensures high purity and reliable consistency for advanced therapeutic applications.

Application

• Pharmaceutical API: Primary ingredient in the manufacture of biologic drugs for treating moderate to severe persistent allergic asthma.
• Biologic Formulation: Used in the development and production of injectable solutions for targeted immunotherapy.
• Clinical Research: Serves as a key reference standard and material in preclinical and clinical studies for IgE-mediated disorders.
• Biosimilar Development: Critical for companies engaged in the research, development, and analytical testing of biosimilar products.
• Specialty Medicine Production: Formulated into final drug products for patients with chronic spontaneous urticaria (CSU).

Basic Information

Product Name	Omalizumab
CAS No.	242138-07-4
Molecular Formula	C6450H9916N1714O2017S44
Molecular Weight	Approx. 149 kDa
Synonyms	rhuMAb-E25; Anti-Human Immunoglobulin E Recombinant Monoclonal Antibody; Xolair (Trade Name); Immunoglobulin E Humanized Monoclonal Antibody; IgE Inhibitor; Olizumab; E-25; rhuMAb E25
EINECS	Contact for details

Quality Control

Our Omalizumab is manufactured and tested under strict quality systems. Each batch is subjected to a comprehensive battery of analytical tests including HPLC for purity and potency, SDS-PAGE and CE-SDS for identity and impurity profile, and biological activity assays to ensure it meets the stringent requirements for pharmaceutical use. Certificates of Analysis (COA) with full traceability are provided, confirming compliance with relevant cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This product is hygroscopic (moisture-sensitive) and must be kept under controlled conditions to maintain stability. For long-term storage, keep desiccated.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0% (Monomer)
Protein Content (UV)	95.0% - 105.0% of label claim
Biological Activity (ELISA/Binding)	≥ 90% of reference standard
Endotoxin (LAL)	< 1.0 EU/mg
Host Cell Proteins (HCP ELISA)	< 100 ppm
Residual DNA (qPCR)	< 10 pg/mg
Moisture Content (KF)	< 3.0%

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