Description

Galsulfase CAS NO 552858-79-4 is a recombinant human enzyme, specifically N-acetylgalactosamine 4-sulfatase, used as a therapeutic agent. This product is critical for the treatment of Mucopolysaccharidosis VI (MPS VI), also known as Maroteaux-Lamy syndrome, a rare lysosomal storage disorder. It is primarily required by pharmaceutical manufacturers, biotechnology companies, and clinical research organizations involved in developing and producing enzyme replacement therapies.

Application

• Enzyme Replacement Therapy (ERT): The primary active pharmaceutical ingredient (API) in Naglazyme® for the treatment of Mucopolysaccharidosis VI.
• Pharmaceutical Formulation: Used in the development and commercial-scale manufacturing of sterile injectable biopharmaceutical products.
• Clinical Research: Serves as a reference standard or investigational material in preclinical and clinical studies for lysosomal storage disorders.
• Biochemical Research: Utilized in laboratory studies to understand glycosaminoglycan (GAG) metabolism, enzyme kinetics, and lysosomal biology.
• Biosimilar Development: Acts as a key component for companies developing biosimilar versions of the innovator biologic drug.

Basic Information

Product Name	Galsulfase
CAS No.	552858-79-4
Molecular Formula	C2540H3868N672O738S18
Molecular Weight	Approx. 56,000 Da
Synonyms	Arylsulfatase B (recombinant human); Recombinant human N-acetylgalactosamine-4-sulfatase; rhASB; Naglazyme (brand name); Galsulfase recombinant; N-acetylgalactosamine-4-sulfatase (human); MPS VI enzyme; Bio-T-Gal 4-sulfatase; GALNS (recombinant form)
EINECS	Contact for details

Quality Control

Our Galsulfase is manufactured and tested under strict quality systems. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, meeting the stringent requirements for biopharmaceutical active substances. Certificates of Analysis (COA) detailing specifications such as purity by HPLC, biological activity (U/mg), endotoxin levels, and sterility are provided and traceable to relevant standards.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -20°C or below. Avoid repeated freeze-thaw cycles. This product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled, dry conditions to maintain stability and activity.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear solution
Identification (HPLC/Peptide Map)	Conforms to reference standard
Purity (SDS-PAGE & SEC-HPLC)	≥ 98.0%
Assay (Enzymatic Activity)	≥ 1.0 U/mg protein
Protein Content	By UV absorbance
Endotoxin	< 1.0 EU/mg
Sterility (where applicable)	Sterile
Moisture Content (for lyophilized)	≤ 3.0%

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