Azithromycin 250 Tablets Ip
| 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 |
| 6.3 | PELAPISAN |
| 6.4 | DETAIL MEREK |
1.0 DETAIL PRODUK:
NAMA PRODUK
Azithromycin Tablets IP
Deskripsi Produk
White color round shape, biconvex, film coated tablets having both side plain
KEKUATAN
250 mg
Klaim Label
Each film coated tablet contains:
Azithromycin (As Dihydrate)
equivalent to Azithromycin Anhydrous – 250 mg
UKURAN BATCH
2,00,000 Tablets
Rata-rata Berat
354 mg
Umur Simpan
24 months
Penyimpanan
Store in a cool, dry and dark place below 25 0 C
Kategori Obat
Antibiotik Makrolida
2.0 FORMULA PEMBUATAN:
| Nama Bahan | Grade | Kategori | Jumlah per Unit (mg) | Kelebihan (%) | Jumlah Batch (kg) |
|---|---|---|---|---|---|
| Azithromycin | IP | API | 250 mg | 5 % | 52.500 kg |
| MCCP Plain | IP | Diluent | 25 mg | — | 5.000 kg |
| PVPK-30 | IP | Binder | 2.0 mg | — | 0.400 kg |
| Sodium Benzoate | IP | Preservative | 0.7 mg | — | 0.140 kg |
| Sodium Starch Glycolate | IP | Binder | 10 mg | — | 2.000 kg |
| Purified Water | IP | Diluent | 0.13 ml | — | 26.000 liter |
| Talcum | IP | Anti-caking agent | 7.0 mg | — | 1.400 kg |
| MCCP PH-102 | IP | Diluent | 25 mg | — | 5.000 kg |
| Cross Carmillose Sodium | IP | Disintegrant | 7.0 mg | — | 1.400 kg |
| Crospovidone XL | IP | Disintegrant | 3.5 mg | — | 0.700 kg |
| Aerosil | IP | Glidant | 1.5 mg | — | 0.300 kg |
| Calcium Stearate | IP | Anti-Adherent | 3.5 mg | — | 0.700 kg |
3.0 DAFTAR PERALATAN:
Sr.No.
| No. | Mesin/Peralatan | Kapasitas | ID Peralatan |
|---|---|---|---|
| 1. | Weighing Balance | 100 kg | |
| 2. | Vibro Sifter | 30 inch dia | |
| 3. | Paste Kettle with stirrer | 100 liter | |
| 4. | Portable Stirrer | — | |
| 5. | Rapid Mixer Granulator (RMG) | 160 liter | |
| 6. | Fluid Bed Dryer (FBD) | 120 kg | |
| 7. | Multi Mill (screen size 2 mm and 8 mm) | — | |
| 8. | Double cone Blender | 400 liter | |
| 9. | Halogen Moisture Balance | — | |
| 10. | Compression Machine | 27 Station | |
| 11. | SS Containers | 10 liter | — 4.0 GENERAL PRECAUTIONS: API Description: A White or almost white color powder. Protected from moisture during storage. 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) |
|---|---|---|---|---|---|
| Azithromycin IP | Dry Mixing | 52.500 kg | 18 # | MCCP Plain IP | |
| PVPK-30 IP | Binder | 0.400 kg | Sodium Benzoate IP | ||
| Talcum IP | Lubricant | 1.400 kg | 60 # | MCCP PH-102 Â IP | |
| NLT 80 % | —- | —- | 13. | Product Description | |
| 02 | — | 3. | Filter Cloth 100 # | ||
| 0.5 mm | — | 4. | Portable Stirrer | ||
| — | — | STEP – III (PREPARATION OF COATING SOLUTION): |
