Description

Pulmozyme (Dornase Alfa) is a highly purified recombinant human deoxyribonuclease I (rhDNase) enzyme, specifically engineered to reduce the viscosity of purulent sputum. This therapeutic protein is critical for managing respiratory complications associated with excessive, thick mucus. It is an essential pharmaceutical active ingredient for manufacturers developing advanced inhalation therapies. The product is identified by CAS No. 143831-71-4.

Application

• As the active pharmaceutical ingredient (API) in inhalation solutions for the treatment of cystic fibrosis (CF).
• Used in nebulizer formulations to hydrolyze extracellular DNA in sputum, improving lung function and reducing infection frequency.
• For clinical research into mucus-clearing therapies for chronic obstructive pulmonary disease (COPD) and other severe respiratory conditions.
• In the development of specialty biopharmaceuticals targeting pulmonary diseases.
• As a reference standard in analytical laboratories for quality control and method development.

Basic Information

Product Name	Pulmozyme (Dornase Alfa)
CAS No.	143831-71-4
Molecular Formula	C1321H1999N339O396S9
Molecular Weight	Approx. 29,300 Da
Synonyms	Dornase Alfa; Recombinant Human Deoxyribonuclease I; rhDNase; DNase I, Human, Recombinant; Deoxyribonuclease I (Human); Pulmozyme®; rh-DNase; DNAase
EINECS	Contact for details

Quality Control

Our Pulmozyme is manufactured under strict conditions to ensure the highest purity and biological activity, suitable for pharmaceutical applications. It is produced in compliance with cGMP (current Good Manufacturing Practice) guidelines. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, potency, and safety profiles, including tests for endotoxins and sterility. Specifications are designed to meet the rigorous standards required for inhalation-grade APIs.

Storage

Preserve in a tightly closed container, protected from light. Store at 2°C to 8°C (refrigerated, do not freeze). This product is hygroscopic (moisture-sensitive) and must be handled in a controlled environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear, colorless solution
Identification (HPLC/Activity)	Conforms
Purity (SDS-PAGE / SEC-HPLC)	≥ 98.0%
Specific Activity	≥ 1.0 x 106 units/mg
Protein Content	As per COA
pH (in solution)	6.0 - 7.0
Endotoxins (LAL)	< 1.0 EU/mg
Sterility	Sterile

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