| Physico-chemical Analysis | |||
| No. | Parameter | Duration Analysis | Method |
|---|---|---|---|
| 1 | Antibiotics microbial assays | 5 days | USP 47 NF 42 |
| 2 | Appearances | 1 day | EP 11.0 |
| 3 | Assay (HPLC) | 2 days | HPLC |
| 4 | Assay (Spectrophotometry UV) | 1 day | UV spectrum |
| 5 | Average mass/volume | 1 day | USP 47 NF 42 |
| 6 | Disintegration (Tablet, capsule, suppository and ovule) | 1 day | USP 47 NF 42 |
| 7 | Identification (IR Spectrum) | 1 day | Compare CRS (EDQM/ USP) |
| 8 | Identification (TLC) | 2 days | USP 47 NF 42 |
| 9 | Loss on drying (moisture) | 1 day | EP 11.0 |
| 10 | pH | 1 day | EP 11.0 |
| 11 | Related substance/ Total impurity | 3 days | HPLC |
| 12 | Water content (Karl Fischer) | 1 day | Automatic titration |
| Microbiological Analysis | |||
| No. | Parameter | Duration Analysis | Method |
| 1 | Bile-tolerant gram-negative bacteria | 5 days | USP 47 NF 42 |
| 2 | Candida albicans | 5 days | USP 47 NF 42 |
| 3 | Efficacy of antimicrobial preservation | 5 days | USP 47 NF 42 |
| 4 | Escherichia.coli | 5 days | USP 47 NF 42 |
| 5 | Gram-negative bacteria | 5 days | USP 47 NF 42 |
| 6 | Pseudomonas aeruginosa | 5 days | USP 47 NF 42 |
| 7 | Saccharomyces | 5 days | USP 47 NF 42 |
| 8 | Salmonella | 5 days | USP 47 NF 42 |
| 9 | Staphylococcus aureus | 5 days | USP 47 NF 42 |
| 10 | Total aerobic microbial count | 5 days | USP 47 NF 42 |
| 11 | Total combined yeasts/molds count | 7 days | USP 47 NF 42 |
| 12 | Personal hygiene test (TAMC&TYMC) | 7 days | USP 47 NF 42 |
| 13 | Room cleanliness control (air contamination control) (TAMC&TYMC) | 7 days | USP 47 NF 42 |
| 14 | Surface swabs from establishment (Equipment and facilities) (TAMC&TYMC) | 7 days | USP 47 NF 42 |
| Stability Study (Shelf life study) | |||
| No. | Parameter | Duration Analysis | Method |
| 1 | Real time study ( T0, T3,T6, T9,T12, T18,T24 & T36) | Base on selected parameters | ASEAN Guidline version2 |
| 2 | Acelerate study (T0, T3,T6, T9 & T12) | Base on selected parameters | ASEAN Guidline version2 |
| Packages fee | |||
| No. | Product | Recommended Test Parameters | |
| 1 | Aerosols (pressurised pharmaceutical preparations) | Identification of the Active substance | |
| 2 | Aerosols (pressurised pharmaceutical preparations) | Active substance assay | |
| 3 | Aerosols (pressurised pharmaceutical preparations) | Preservative content (where appropriate) | |
| 4 | Capsules | Appearance | |
| 5 | Capsules | Identification of the active substance | |
| 6 | Capsules | Uniformity of content/mass | |
| 7 | Capsules | Active substance assay | |
| 8 | Capsules | Impurities (where appropriate) | |
| 9 | Capsules | Disintegration time | |
| 10 | Capsules | Dissolution profile (where appropriate) | |
| 11 | Collars/ear tags | Appearance | |
| 12 | Collars/ear tags | Identification of the active substance | |
| 13 | Collars/ear tags | Uniformity of content/mass | |
| 14 | Collars/ear tags | Active substance assay | |
| 15 | Oral powders, Granules | Appearance, colour, clarity | |
| 16 | Oral powders, Granules | Identification of the active substance | |
| 17 | Oral powders, Granules | Active substance assay | |
| 18 | Oral powders, Granules | Moisture content | |