| 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 | Aspect of Solution S | 1 day | EP 11.0 |
| 4 | Assay (HPLC) | 2 days | HPLC |
| 5 | Assay (Spectrophotometry UV) | 1 day | UV spectrum |
| 6 | Average mass/volume | 1 day | USP 47 NF 42 |
| 7 | Chemical reaction | 1 day | USP 47 NF 42 |
| 8 | Disintegration (Tablet, capsule, suppository and ovule) | 1 day | USP 47 NF 42 |
| 9 | Dissolution | 2 days | 1 API = $50, 2 API = $80, 3 API = $120 |
| 10 | Friability | 1 day | USP 47 NF 42 |
| 11 | Hardness (Tablet, capsule, suppository and ovule) | 1 day | EP 11.0 |
| 12 | Identification (IR Spectrum) | 1 day | Compare CRS (EDQM/ USP) |
| 13 | Identification (TLC) | 2 days | USP 47 NF 42 |
| 14 | Loss on drying (moisture) | 1 day | EP 11.0 |
| 15 | Melting Point | 1 day | EP 11.0 |
| 16 | pH | 1 day | EP 11.0 |
| 17 | Reaction precipitation | 1 day | EP 11.0 |
| 18 | Solubility | 1 day | EP 10.0 |
| 19 | Synthetic/Artificial Colors/ Tar colors | 3 days | HPLC |
| 20 | Toxicity (Diethylen glycol) | 2 days | GCMS-MS |
| 21 | Toxicity (Ethylen glycol) | 2 days | GCMS-MS |
| 22 | Total Acidity | 1 day | Titration |
| 23 | Uniformity of content | 2 days | HPLC/UV spectrum |
| 24 | Uniformity of mass/ volume | 1 day | USP 47 NF 42 |
| 25 | 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) | Based on selected parameters | ASEAN Guideline version 2 |
| 2 | Accelerate study (T0, T3, T6, T9 & T12) | Based on selected parameters | ASEAN Guideline version 2 |
| Packages fee | |||
| No. | Parameter | Duration Analysis | Method |
| 1 | Pharmaceutical Products (Finish Product, Intermediate Product, Bulk Product for solid form) | 1 API=150, 2 API=175, 3 API=200 | Physicochemical & dissolution test |
| 2 | Pharmaceutical Products (Finish Product, Intermediate Product, Bulk Product for liquid and semi-solid form) | 1 API=100, 2 API=125, 3 API=150 | Physicochemical & Microbiological |
| 3 | Active Pharmaceutical Ingredients | $100.00 | Physicochemical & Microbiological |
| 4 | Excipients | $100.00 | Physicochemical & Microbiological |