Tablet Betahistin 16 mg
| No. | Judul |
|---|---|
| 1.0 | DETAIL PRODUK |
| 2.0 | FORMULA PEMBUATAN |
| 3.0 | DAFTAR PERALATAN |
| 4.0 | INSTRUKSI PEMBUATAN |
| 5.0 | PENGAWASAN UMUM |
| 6.0 | DETAIL PROSES PEMBUATAN |
1.0 DETAIL PRODUK:
NAMA PRODUK
Betahistine Tablets
Deskripsi Produk
White color round shape, uncoated tablet having one side mid break line
KEKUATAN
16 mg
Klaim Label
Each uncoated tablet contains:
Betahistine Dihydrochloride IP -16 mg
UKURAN BATCH
1,00,000 Tablets
Rata-rata Berat
120 mg
Umur Simpan
24 months
Penyimpanan
Store in a cool, dry and dark place below 25 0 C.
Kategori Obat
Anti-vertigo
2.0 FORMULA PEMBUATAN:
| Nama Bahan | Grade | Kategori | Jumlah per Unit (mg) | Kelebihan (%) | Jumlah Batch (kg) |
|---|---|---|---|---|---|
| Betahistine Dihydrochloride IP | IP | API | 16.30 mg | 1.630 kg | MCCP PH -102 |
| Ethyl Cellulose IP | IP | Binder | 0.1 mg | 0.010 kg | IPA |
| MCCP PH – 112 IP | IP | Diluent | 14.0 mg | 1.400 kg | Aerosil IP |
| Talcum IP | IP | Anti-caking agent | 5.00 mg | 0.500 Kg | Magnesium Stearate IP |
| Stirrer for binder preparation | — | SC/PD/STR/01 | |||
| Halogen Moisture Balance | — | SC/QC/007 | |||
| 45 liter (01 No’s) | — | 10. | SS Containers with lid | ||
| 0.5M | — |
4.0 INSTRUKSI PEMBUATAN:
All the manufacturing activities shall be performed under controlled conditions (temperature NMT 25 0 C and relative humidity NMT 45 %).
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 PENGAWASAN UMUM:
Before working with Betahistine Hydrochloride, read Material Safety Data Sheet of Active Ingredients.
In case of skin contact (Irritants), wash skin with soap and water for at least 15 minutes. Cold water may be used.
To protect the eyes, use goggles and in case of infection wash the eyes thoroughly with running water.
General reported side effect:Feeling Sick (Nausea), Indigestion, Headache, Allergic skin reactions such as Itching and Rash.
PROSES PEMBUATAN DETAILS:
6.1 GRANULASI:
STEP – I (SIFTING):
Check Sieve Integrity (before sifting and after sifting).
Set the Sifter and sieve the dispensed materials as per Sieve Sizes mentioned below:
| Nama Bahan | Grade | Kategori | Jumlah per Unit (mg) | Kelebihan (%) | Jumlah Batch (kg) |
|---|---|---|---|---|---|
| MCCP PH – 112 IP | Lubricant | 1.400 kg | 30≠| Aerosil IP |
