Description

Sapropterin Hydrochloride is a synthetic, biologically active form of tetrahydrobiopterin (BH4), a critical cofactor for aromatic amino acid hydroxylases. This high-purity active pharmaceutical ingredient (API) is essential for the treatment of specific metabolic disorders, offering a targeted therapeutic approach. It is primarily required by pharmaceutical manufacturers and research institutions focused on developing and producing treatments for phenylketonuria (PKU) and other BH4-responsive conditions.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for the treatment of phenylketonuria (PKU).
• Metabolic Disorder Research: Critical research reagent for studying tetrahydrobiopterin (BH4) deficiency, neurotransmitter synthesis, and nitric oxide synthase activity.
• Formulation Development: Used in the development of solid oral dosage forms, such as tablets and dispersible tablets, requiring high stability and bioavailability.
• Clinical Diagnostics: May serve as a reference standard in biochemical assays and diagnostic kits for monitoring BH4 levels and related metabolic pathways.
• Preclinical Studies: Utilized in animal models to investigate the efficacy and pharmacokinetics of BH4 replacement therapy.

Basic Information

Product Name	Sapropterin Hydrochloride
CAS No.	69056-38-8
Molecular Formula	C9H15N5O3 • HCl
Molecular Weight	277.71 g/mol (Free base: 241.25 g/mol)
Synonyms	6R-BH4 Dihydrochloride; (6R)-5,6,7,8-Tetrahydrobiopterin Dihydrochloride; 6R-Tetrahydrobiopterin Dihydrochloride; BH4 Dihydrochloride; Kuvan (Brand Name API); Sapropterin Dihydrochloride; 2-Amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydropteridin-4(1H)-one Hydrochloride
EINECS	Contact for details

Quality Control

Our Sapropterin Hydrochloride is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure compliance with relevant pharmacopeial standards (e.g., USP monographs) and support regulatory filings with consistent, high-quality material.

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 corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Specific Rotation	Contact for details
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Microbial Enumeration	Meets Ph. Eur. 2.6.12/2.6.13 criteria

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