Product Composition & Structure

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Formulation 2 options — component shares are % of the finished formulation
Saxagliptin Hydrochloride (API) primary base: Saxagliptin hydrochloride DPP-4 inhibitor drug
ComponentRoleShareSourceable matches
Saxagliptin hydrochloride Active pharmaceutical ingredient
98٫28% (98–102)
Water Residual moisture
0٫983% (0–2)
Organic impurities (related substances) Process impurities
0٫491% (0–1)
Residual solvents (e.g., ethanol, acetone) Solvent residues
0٫246% (0–0٫5)
Saxagliptin Hydrochloride (Tablet Formulation) base: Saxagliptin hydrochloride DPP-4 inhibitor drug
ComponentRoleShareSourceable matches
Microcrystalline cellulose Filler/binder
47٫368% (30–60)
Lactose monohydrate Filler
36٫842% (20–50)
Croscarmellose sodium Disintegrant
5٫263% (2–8)
Saxagliptin hydrochloride Active ingredient
5٫263% (2–10)
Opadry (film coating) Film coating
3٫684% (2–5)
Magnesium stearate Lubricant
1٫053% (0٫5–2)
Colloidal silicon dioxide Glidant
0٫526% (0٫1–1)

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kg
Component
Material BASE
Percentage (%): 0%
Required Weight: 0 kg
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