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MATRIKS PRODUK EFFERVESCENT

a. Akan Diproduksi
Formula
Parameter Uji
No Nama Produk No NIE Tgl Izin Edar ED Izin Edar Komposisi
Bahan Baku Tiap Batch Metode Analisis Kualitatif Referensi Metode Analisis Kuantitatif Referensi

1 Merzavit-C500 POM SD201541031 22 APR 20 22 APR 25 Vitamin C 500 mg Fase Dalam Identifikasi Vitamin C In House Method Titrasi (Kadar Vit C) In House Method
Povidon K-30 Uji bakteri Patogen United States Uji cemaran bakteri United States
750,0 g Pharmacopoeia 38 Pharmacopoeia 38
Eurocert sunset yellow Uji cemaran jamur United States
32,0 g Pharmacopoeia 38
Purified water 500,0 mL
Ethanol 96% 1.000,0 mL
Citric Acid Anhydrat 52.500,0 g
mannitol 5.373,0 g
sucralose 925,0 g
Fase Luar
Vitamin C uncoated 12.500,0 g
Sodium Bicarbonat 30.770,0 g
Orange Powder 1.650,0 g
PEG 6000 Powder 5.500,0 mL
2 Loco-CDR Tahap pengembangan NA NA Fase Dalam Identifikasi Vitamin C In House Method Titrasi (Kadar Vit C) In House Method
Povidon K-30 vitamin B6 FI edisi V HPLC (kadar Vit B6) FI edisi V
- Vitamin C 1000 mg 750,0 g

- Vitamin D3 Eurocert sunset yellow 32,0 g Calcium carbonat FI edisi V titrasi (Kadar Ca.Carbonat) FI edisi V
- Vitamin B6 Purified water 500,0 mL Zinc FI edisi V titrasi (Kadar Zinc) FI edisi V
Ethanol 96% Uji bakteri Patogen United States Uji cemaran bakteri United States
- Calcium Carbonat 1.000,0 mL Pharmacopoeia 41 Pharmacopoeia 41
Citric Acid Anhydrat Uji cemaran jamur United States
- Zinc 10 mg 39.010,0 g Pharmacopoeia 41
mannitol 5.374,0 g
sucralose 925,0 g
Vitamin C uncoated 25.000,0 g
Fasa Luar
Vitamin D3 75,0 g
Pyridoxine HCl 375,0 g
Calcium Carbonat 15.625,0 g
Zinc Sulfat 686,0 g
Sodium Bicarbonat 15.000,0 g
Orange Powder 1.650,0 g
PEG 6000 Powder 5.500,0 g
3 Amunizer Tahap pengembangan NA NA Zat Aktif : Identifikasi pyridoxine United States HPLC United States
(HPLC) Pharmacopoeia 41 Pharmacopoeia 41

Uji bakteri Patogen United States Uji cemaran bakteri United States
Pharmacopoeia 41 Pharmacopoeia 41

Uji cemaran jamur United States


Pharmacopoeia 41

Bahan Penolong :
Confidential

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