We supply Sapropterin hydrochloride

Our company offers Sapropterin hydrochloride, a pharmaceutical product used to treat cases with phenylketonuria( PKU). it is a synthetic form of tetrahydrobiopterin( BH4) that helps in regulating situations of phenylalanine in the body. PKU is a rare inheritable complaint that affects individualities who can not break down phenylalanine from protein-rich foods, leading to brain damage in severe cases. it has experienced rigorous testing and meets the loftiest assiduity norms for safety and efficacity. We're committed to furnishing quality drug to cases suffering from PKU.

What is Sapropterin dihydrochloride?

Sapropterin dihydrochloride is a drug used to treat individualities with phenylketonuria( PKU). PKU is a inheritable complaint that causes the body to be unfit to break down phenylalanine, an amino acid set up in numerous foods. This can lead to a buildup of phenylalanine in the blood, which can affect in severe intellectual disability, behavioral problems, and other health issues.

it works by helping the body produce further of an enzyme called tetrahydrobiopterin( BH4), which is necessary for the processing of phenylalanine. By adding the situations of BH4 in the body, it can lower the quantum of phenylalanine in the blood and reduce the threat of health problems associated with PKU.

it is generally taken daily as a tablet or as a greasepaint mixed with water. The lozenge is acclimatized to the existent's specific requirements and may be acclimated over time grounded on the response to treatment. It's important to follow the dosing instructions handed by a healthcare provider, as well as to follow a special low- phenylalanine diet to help manage symptoms of PKU.

Like any drug, it can beget side goods in some people. Common side goods may include headaches, nausea, puking, diarrhea, stomach pain, and loss of appetite. In rare cases, it may beget an antipathetic response. It's important to report any unusual or severe side goods to a healthcare provider incontinently.

Overall, it can be an effective treatment option for individualities with PKU who need to manage their phenylalanine situations. With the right dosing and diet, it may help reduce the threat of health problems associated with PKU and ameliorate quality of life.

Basic Information

Product Name: Sapropterin dihydrochloride

CAS: 69056-38-8

MF:C9H17Cl2N5O3

MW:314.17

EINECS:663-669-3

MDL No.:MFCD00891665

Melting point:245-246° (dec)

alpha D25 -6.81° (c = 0.665 in 0.1 M HCl)

Structural formula:

Origin: China

Delivery Time: in stock

Technical Specification

Package: 1g;10g; 1kg or according to your demands

Storage: Preserve in tight,light-resistant containers in cool place

Shelf Life:Powder: 2 years

Application

Sapropterin hydrochloride is a synthetic form of dihydrobiopterin, a naturally being substance in the body that helps to spark an important enzyme called phenylalanine hydroxylase( PAH). PAH is responsible for converting the amino acid phenylalanine into tyrosine, which is essential for numerous fleshly functions.

it is used as a treatment for phenylketonuria( PKU), a inheritable complaint that affects the way the body processes the amino acid phenylalanine. In people with PKU, PAH is either absent or not performing duly, which leads to a buildup of phenylalanine in the blood and brain. This can beget a variety of symptoms, including intellectual disability, seizures, and behavioral problems.

it works by furnishing the body with further dihydrobiopterin, which can help to spark any remaining or incompletely performing PAH enzymes. This can reduce the buildup of phenylalanine in the blood and brain, and ameliorate symptoms associated with PKU.

it is generally given as an oral tablet or greasepaint that's mixed with water. The lozenge and administration schedule will vary depending on the existent's age, weight, and inflexibility of their PKU. It's important to follow the instructions handed by the healthcare provider and to attend regular check- ups to cover the effectiveness and safety of the treatment.

In clinical trials, it has been shown to be effective in reducing blood phenylalanine situations and perfecting cognitive function in cases with PKU. It's generally well- permitted, with the most common side goods being headache, nausea, and puking.

Overall, it is an important treatment option for people with PKU. By helping to drop phenylalanine situations and ameliorate cognitive function, it can ameliorate the quality of life for those affected by this inheritable complaint.

Biological activity 

Sapropterin dihydrochloride is a pharmaceutical emulsion that has been shown to have robust natural exertion in a variety of settings. This emulsion is a form of tetrahydrobiopterin, which is an essential cofactor for the product of neurotransmitters similar as serotonin, dopamine, and norepinephrine. it is used primarily as a drug for the treatment of phenylketonuria( PKU), which is a inheritable complaint that leads to a buildup of phenylalanine in the body. This buildup can affect in intellectual disability, seizures, and other health problems if left undressed.

it works by adding product of an enzyme called phenylalanine hydroxylase, which is necessary to break down phenylalanine in the body. By boosting this enzyme's exertion, it can help to reduce phenylalanine situations and help them from reaching dangerous situations. In addition to its use in PKU treatment, it has also been delved as a implicit treatment for a range of other conditions, including depression, Parkinson's complaint, and autism diapason complaint.

Clinical trials have demonstrated the efficacity of sapropterin hydrochloride in the operation of PKU, with reductions in phenylalanine situations of over to 50 reported in some cases. In addition, cases treated with the medicine have shown advancements in cognitive function, as well as reductions in the prevalence of seizures and other PKU- related complications. it has also been shown to be generally well- permitted, with many serious adverse goods reported in studies to date.

Overall, it represents an instigative pharmaceutical invention that has the implicit to make a significant impact on the lives of individualities living with PKU. Ongoing exploration into the emulsion's implicit operations in other areas of drug may lead to farther improvements in the future, and it remains an area of active disquisition among experimenters and healthcare professionals.

Preparation

A. Hydrolysis of diacetylbiopterin

To a mixture of diacetylbiopterin (approximately 50 g of diacetylbiopterin equivalent, 155 mmol) in 1-butanol (128 mL) was added distilled water (200 mL) and diethylamine (26 g, 355 mmol) at ambient temperature (20-25℃). The mixture was stirred at 40 ℃ for 16 hours, at which time the mixture contained ≤5c diacetylbiopterin a/a (area under the chromatogram curve) as determined by HPLC. The aqueous and organic phases were allowed to settle without stirring and the aqueous layer was collected. The organic layer was mixed with distilled water (160 mL) at 60℃ for 1 hour, the two phases were separated and the aqueous layer was collected. The combined aqueous layers were filtered through Vitacel (2 g) and the filter cake was washed with distilled water (2×36 mL).

B. Hydrogenation of Biopterin

Triethylamine (136 mL) was added to the combined aqueous solution containing biopterin from the previous step at 25°C to bring its pH down to 11.2. The mixture was placed in an autoclave after platinum black (1.2 g, 6 mmol) was added as a slurry in 20 mL of distilled water. Following a purge with nitrogen and hydrogen (3×2 bar nitrogen, 3×35 bar hydrogen), the mixture was agitated at 1,000 rpm for 23 hours under 35 bar hydrogen. During this period, HPLC analysis revealed that the mixture contained ≤1% biopterin a/a and ≤8% 7,8-dihydrobiopterin a/a.After nitrogen was added to the mixture, the platinum catalyst was filtered off. The pH of the filtrate was lowered to pH <1.0. C. by gradually adding 33% HCl (120 g, or approximately 100 mL) at 25°C in order to improve the stability of tetrahydrobiopterin in solution. 6R)-5,6,7,8-Tetrahydrobiopterin Dihydrochloride Isolation of "Crude" About 375 g (375 mL) of water were extracted from the above acidified aqueous solution containing crude (6R)-5,6,7,8-tetrahydrobiopterin dihydrochloride by distillation at a temperature of 40–60°C and reduced pressure (50–200 mbar). Acetic acid was extracted from the water by azeotropic distillation, which was created by the hydrolysis of diacetylbiopterin and subsequent acidification.Karl-Fischer measured the water content of the concentrated liquid and found that it was < 23% w/w after adding ethanol (58 mL). 200 mL of additional ethanol and 58 mL of 1-butanol were added to the mixture at 60°C. The mixture was then cooled to 35°C and agitated at that temperature for six hours, all while maintaining a 60°C temperature in order to encourage the crystallization of the "crude" (6R)-5,6,7,8-tetrahydrobiopterin dihydrochloride salt. After filtering, the crystalline product (2×25 mL) was cleaned with ethanol.

Packing & Shipping

Packing：1kg/foil bag;5kg/carton;25kg/fiber drum;or packing as your request.

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