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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.

Saquinavir EP Impurity G (Free Base)

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Catalogue No.:	VE0025233
CAS No.:	N/A
Mol. Formula:	C39H51N5O6
Mol. Weight:	685.85 g/mol

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Additional information on Saquinavir EP Impurity G (Free Base)

Parent drug

Saquinavir

IUPAC Name

Methyl (3S)-4-[[(1S, 2R)-1-Benzyl-3-[(3S, 4aS, 8aS)-3-[(1, 1-dimethylethyl)carbamoyl]octahydroisoquinolin-2(1H)-yl]-2-hydroxypropyl]amino]-4-oxo-3-[(quinolin-2-ylcarbonyl)amino]butanoate

Pharmacopoeial Synonyms

N/A

Other Synonyms

N/A

Smiles

O=C(N[C@@](CC(OC)=O)(C(N[C@](CC1=CC=CC=C1)([H])[C@](O)(CN2C[C@](CCCC3)([H])[C@]3([H])C[C@]2(C(NC(C)(C)C)=O)[H])[H])=O)[H])C4=NC5=C(C=C4)C=CC=C5

InChI

InChI=1S/C39H51N5O6/c1-39(2, 3)43-38(49)33-21-27-15-8-9-16-28(27)23-44(33)24-34(45)31(20-25-12-6-5-7-13-25)41-37(48)32(22-35(46)50-4)42-36(47)30-19-18-26-14-10-11-17-29(26)40-30/h5-7, 10-14, 17-19, 27-28, 31-34, 45H, 8-9, 15-16, 20-24H2, 1-4H3, (H, 41, 48)(H, 42, 47)(H, 43, 49)/t27-, 28+, 31-, 32-, 33-, 34+/m0/s1

Description

Saquinavir EP Impurity G (Free Base) is a characterized degradation impurity observed in saquinavir drug substance batches and stability studies. This impurity is routinely monitored within EP specification frameworks and quantified by validated HPLC methods complemented by MS and NMR for structural confirmation. Analytical attributes include distinct chromatographic retention behavior | diagnostic mass spectral fragments and UV absorbance maxima enabling reliable detection at trace levels. Control of Impurity G is essential for impurity profiling | stability assessment and regulatory submission under ICH guidelines. Comprehensive reference documentation supports identification | quantification and investigation of root causes during process development and batch release testing.