Tablet Deflazakort
| No. | Judul |
|---|---|
| 1.0 | DETAIL PRODUK |
| 2.0 | FORMULA PEMBUATAN |
| 3.0 | DAFTAR PERALATAN |
| 4.0 | PENGAWASAN UMUM |
| 5.0 | INSTRUKSI PEMBUATAN |
| 6.0 | DETAIL PROSES PEMBUATAN |
| 6.1 | GRANULASI |
| 6.2 | KOMPRESI |
1.0 DETAIL PRODUK:
NAMA PRODUK
Deflazacort Tablets
Deskripsi Produk
White color round shape, uncoated tablet having one side mid break line and other side plain.
KEKUATAN
6 mg
Klaim Label
Each uncoated tablet contains:
Deflazacort – 6 mg
UKURAN BATCH
5,00,000 Tablets
Rata-rata Berat
110 mg
Umur Simpan
24 months
Penyimpanan
Store in a cool, dry and dark place below 25 0 C.
Kategori Obat
Obat Kortikosteroid
2.0 FORMULA PEMBUATAN:
| Nama Bahan | Grade | Kategori | Jumlah per Unit (mg) | Kelebihan (%) | Jumlah Batch (kg) |
|---|---|---|---|---|---|
| Deflazacort | — | API | 6 mg | 3.000 kg | Sodium Starch Glycolate |
| Talcum | IP | Anti-caking agent | 5 mg | 2.500 kg | Starch |
| Aerosil | IP | Glidant | 1.5 mg | 0.750 kg | Lubricant |
| MCCP PH-112 | IP | Diluent | 83.17 mg | 41.585 kg | Magnesium Stearate |
3.0 DAFTAR PERALATAN:
Sr. No.
| No. | Mesin/Peralatan | Kapasitas | ID Peralatan |
|---|---|---|---|
| 1. | Weighing Balance | 100 kg | |
| 2. | Vibro Sifter | 30 inch dia. | |
| 3. | Octagonal Blender | 60 liter | |
| 4. | Double Cone Blender | 200 liter | |
| 5. | Compression Machine | 35 Station | |
| 6. | Halogen Moisture Balance | — | 4.0 GENERAL PRECAUTIONS: API Description: A white or creamy white color crystalline powder. All the Manufacturing Activities shall be performed under controlled conditions (temperature NMT 25 0 C and relative humidity NMT 60%). When working with Active Ingredients and drug product or mixture of Active Ingredients and Excipients, wear gloves and mask to avoid exposure and contact with any body parts. 5.0 MANUFACTURING INSTRUCTIONS: All activities shall be performed as per current SOPs. Take the line clearance from QA before starting the manufacturing operation during batch to batch and product to product change over. Do not overwrite the entry. In case of mistake, cancel the entry by single line with sign & date and make correct entry. |
6.1 GRANULASI:
STEP – I (SIFTING):
Check Sieve integrity (before sifting and after sifting).
Set the Vibro Sifter (capacity: 30 inch dia.) and sieve the Dispensed Materials as per Sieve sizes mentioned below:
| Nama Bahan | Grade | Kategori | Jumlah per Unit (mg) | Kelebihan (%) | Jumlah Batch (kg) |
|---|---|---|---|---|---|
| Deflazacort | Dry Mixing | 3.000 kg | 60 # | Sodium Starch Glycolate IP | |
| MCCP-PH-112 IP | Lubricant | 41.585 kg | 30 # | Magnesium Stearate IP |
