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New Product Proposal Formulation Development 30maret 2019
New Product Proposal Formulation Development 30maret 2019
Asiklovir_Tablet_250 mg_
Generic name_Dosageforms_ Strength_Units
Project Information
Product Name
Composition (Active ingredients, strength, dosage form) Asiklovir, 250 mg, tablet
Indication Antivirus
Originator
Other Generic Product (include branded generic)
Strategy Low cost, 1st copy, etc
Targeted Country Indonesia, Other Countries (if any)
Pack Size
Expected Launching Date
Filled by Formulation
Proposed Finished Product Specification
Proposed Specification
Parameter During shelf life Reference
At release
(Registration)
Dosage 250 mg
Appearance White
Uniformity of weight
Disintegration Time Farmakope Indoesia
Uniformity of dosage unit
Identification KCKT KCKT Farmakope Indoesia
Assay 90,0%-110% Farmakope Indoesia
45 menit harus larut
Dissolution Farmakope Indoesia
tidak kurang dari 80%
Impurity tidak lebih dari 0,5% Farmakope Indoesia
Microbiological Quality
Filled by Formulation
Proposed Manufacturing
Equipment & Batch Size
Manufacturing Step R&D Scale Up Pilot Scale Commercial
Batch Size
Primary Pack
Secondary Pack