Product Composition & Structure

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Formulation 2 options — component shares are % of the finished formulation
Leuprolide Acetate Injection primary base: Leuprolide acetate Pharmaceutical peptide
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 pharmaceutical ingredient
0٫3% (0٫1–0٫5)
Leuprolide Acetate Depot Microspheres base: Leuprolide acetate in PLGA microspheres Pharmaceutical peptide
ComponentRoleShareSourceable matches
Poly(lactic-co-glycolic acid) (PLGA) Polymer matrix for sustained release
77٫5% (70–85)
Leuprolide acetate Active pharmaceutical ingredient
10% (5–15)
Mannitol Stabilizer and bulking agent
10% (5–15)
Carboxymethylcellulose sodium Suspending agent
2% (1–3)
Polysorbate 80 Surfactant
0٫3% (0٫1–0٫5)
Water for injection Residual moisture
0٫2%

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