Description

Drotrecoginum Alfa CAS NO 98530-76-8 is a recombinant form of human activated protein C, a serine protease with significant anticoagulant and anti-inflammatory properties. This compound is critical for therapeutic applications targeting severe physiological imbalances. It is primarily required by the pharmaceutical and advanced biopharmaceutical research sectors for the development of treatments for severe sepsis and related conditions.

Application

• Pharmaceutical Active Ingredient: Core component in the formulation of recombinant human activated protein C (rhAPC) therapies.
• Sepsis Treatment: Used in the development of biologics aimed at reducing mortality in adult patients with severe sepsis and high risk of death.
• Anticoagulant Research: Serves as a key reference standard and reagent in hematology and coagulation pathway studies.
• Anti-inflammatory Agent Development: Investigated for its cytoprotective and anti-inflammatory effects in preclinical and clinical research.
• Biopharmaceutical Manufacturing: Employed in downstream processing and quality control for biologic drug production under GMP conditions.
• Reference Standard: Used in analytical laboratories for method development, validation, and assay calibration (HPLC, bioassay).

Basic Information

Item	Detail
Product Name	Drotrecoginum Alfa
CAS No.	98530-76-8
Molecular Formula	C2032H3199N551O642S22
Molecular Weight	Approx. 55,000 Da
Synonyms	Recombinant Human Activated Protein C; rhAPC; Activated Drotrecogin Alfa; Protein C, Activated, Human, Recombinant; Xigris (former brand name); LY203638; (1S,4aR,4bS,7R,8aS,9S,10aS,10bS,12aS)-1,7-Dihydroxy-9-(2-hydroxyacetyl)-4b,8,8,12a-tetramethyl-1,2,3,4,4a,4b,5,6,7,8,8a,9,10,10a,10b,11,12,12a-octadecahydrochryseno[3,4-b]furan-6-one
EINECS	Contact for details

Quality Control

Our Drotrecoginum Alfa is manufactured and controlled to meet exacting standards for biopharmaceutical use. Each batch undergoes comprehensive analytical testing including identity confirmation by peptide mapping, purity assessment by multiple orthogonal methods (e.g., SDS-PAGE, SEC-HPLC), and potency determination via functional bioassay. Certificates of Analysis (COA) documenting purity, biological activity, endotoxin levels, and sterility are provided to ensure compliance with relevant ICH guidelines and GMP principles for advanced therapeutic substances.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive). For long-term storage, keep desiccated. Avoid repeated freeze-thaw cycles. Handle under controlled, aseptic conditions appropriate for a protein therapeutic.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (Peptide Map)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 95.0%
Purity (SDS-PAGE, reduced)	Single band, ≥ 98.0%
Assay (Biological Activity)	≥ 90% to ≤ 110% of labeled potency
Protein Content	≥ 90% (by UV absorbance)
Endotoxin	< 10 EU/mg
Sterility (where applicable)	Sterile
Water Content (Karl Fischer)	≤ 3.0%

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