Aliskiren Hemifumarate It is a drug substance It is the salt or ester form of the product with the International Proprietary name (INN) Aliskiren. Its national approved name (USAN) is Aliskiren fumarate. The chemical name of the product is (2S, 4S, 5S, 7S) –N-(2-Carbamoyl- 2- methylpropyl)-5-amino-4-hydroxy-2, 7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy) phenyl]octanamide hemi-fumarate. In addition to the USAN Aliskiren fumarate, the product also goes by an additional name of (2S, 4S, 5S, 7S)-5-Amino-4-hydroxy-2-isopropyl-7-[4-methoxy-3-(3-methoxy-propoxy) benzyl]-8-methylnonanoic acid (2-carbamoyl-2-methyl-propyl) amide hemi-fumarate. Molecular Formula C30H53O6 0.5C4H4O4, Sal form 609.8(551.8 as free base). Aliskeren is a single diasteroisomer having 4 chiral centre. The active substance is the hemi-fumarate salt of the corresponding amine, with a molecular weight of 609.8 physical form - white to slightly yellowish powder

G.I.R 1 & 6 Notes to Section VI & Chapter 29 HSEN to Chapter 29 and Heading 2924 Text to codes 2924, 292429 & 29242970 Lab advice