Sapropterin Impurity H (Sulfate Salt)
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Documentation

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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

Sapropterin Impurity H (Sulfate Salt)

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Catalogue No.:VE0023169
CAS No.:N/A
Mol. Formula:C9H15N5O3.1/2H2SO4
Mol. Weight:241.25:1/2(98.07) g/mol

Additional information on Sapropterin Impurity H (Sulfate Salt)

Parent drug

Sapropterin

IUPAC Name

(S)-2-amino-6-((1R, 2S)-1, 2-dihydroxypropyl)-5, 6, 7, 8-tetrahydropteridin-4(1H)-one Sulfate salt

Pharmacopoeial Synonyms

N/A

Other Synonyms

N/A

Smiles

NC(NC1=C2N[C@@]([C@@H](O)[C@@H](O)C)([H])CN1)=NC2=O

InChI

InChI=1S/C9H15N5O3/c1-3(15)6(16)4-2-11-7-5(12-4)8(17)14-9(10)13-7/h3-4, 6, 12, 15-16H, 2H2, 1H3, (H4, 10, 11, 13, 14, 17)/t3-, 4-, 6-/m0/s1

Description

The Sapropterin Impurity H (Sulfate Salt) standard is a well-characterized compound that aligns with key regulatory guidelines | including USP | EMA | JP | and BP. It plays a crucial role in analytical method development | method validation (AMV) | and quality control (QC) processes | particularly in the manufacturing of [Parent Drug]. This impurity standard is valuable for both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA) | ensuring reliable and precise analytical outcomes. To further support research and development | it comes with a comprehensive Structure Elucidation Report (SER) | providing detailed insights for advanced analysis.

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