Description

Sapropterin CAS NO 27070-47-9 is a synthetic, biologically active form of tetrahydrobiopterin (BH4), a critical cofactor for aromatic amino acid hydroxylases. This high-purity compound is essential for research and pharmaceutical applications targeting metabolic disorders related to BH4 deficiency. It is primarily utilized by pharmaceutical manufacturers, clinical research organizations, and academic institutions focused on metabolic and neurological research.

Application

• Active Pharmaceutical Ingredient (API): Core component in the formulation of prescription drugs for the treatment of phenylketonuria (PKU) and other BH4-responsive conditions.
• Biochemical Research: Used as a critical cofactor in enzymatic studies, particularly for phenylalanine, tyrosine, and tryptophan hydroxylases.
• Diagnostic Reagent Development: Employed in the development of assays and kits for the diagnosis of neurotransmitter and pterin-related disorders.
• Cell Culture & Neuroscience Studies: Applied in research models to study nitric oxide synthase activity, neurotransmitter synthesis, and cellular redox states.
• Reference Standard: Serves as a high-purity analytical standard for quality control and method validation in pharmaceutical laboratories.

Basic Information

Product Name	Sapropterin
CAS No.	27070-47-9
Molecular Formula	C9H15N5O3
Molecular Weight	241.25 g/mol
Synonyms	6R-BH4; (6R)-5,6,7,8-Tetrahydrobiopterin; Tetrahydrobiopterin; BH4; Sapropterin Dihydrochloride; Kuvan® (Brand Name); 6R-L-erythro-5,6,7,8-Tetrahydrobiopterin
EINECS	Contact for details

Quality Control

Our Sapropterin is manufactured under strict quality systems to meet the exacting standards of the pharmaceutical industry. Each batch is subjected to comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling via HPLC and other validated methods. A Certificate of Analysis (COA) detailing all specifications and test results is provided with every shipment to ensure full traceability and compliance with cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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