Product Composition & Structure

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Formulation 2 options — component shares are % of the finished formulation
Leuprolide Acetate Injection primary base: Leuprolide acetate Peptide active pharmaceutical ingredient
ComponentRoleShareSourceable matches
Water for injection Vehicle
97٫9% (97٫5–98٫3)
Benzyl alcohol Preservative
1% (0٫9–1٫1)
Sodium chloride Tonicity agent
0٫8% (0٫7–0٫9)
Leuprolide acetate Active ingredient
0٫3% (0٫1–0٫5)
Leuprolide Acetate Depot Suspension base: Leuprolide acetate Peptide active pharmaceutical ingredient
ComponentRoleShareSourceable matches
Mannitol Bulking agent and stabilizer
50% (40–60)
Poly(lactic-co-glycolic acid) (PLGA) Polymer matrix for sustained release
40% (30–50)
Water for injection Vehicle (reconstitution)
4٫8%
Leuprolide acetate Active ingredient
4% (3–5)
Carboxymethylcellulose sodium Suspending agent
1% (0٫5–1٫5)
Polysorbate 80 Surfactant
0٫2% (0٫1–0٫3)

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