本實驗室接受委託檢驗,並接受查廠。
委託檢驗項目可依照USP、EP、JP、BP及中華藥典進行分析,
也可依照廠商提供方法或華友開發方法進行分析。
本實驗室提供快速而且精確的服務,歡迎來電洽詢。
本實驗室已通過TFDA核備項目,摘要如下:
| 原料藥/成品製劑 | 檢驗項目 |
|---|---|
| Sodium Bicarbonate, Sodium Polyaclylate | 鈉含量 |
| Sodium Hydroxide, Yellow Iron Oxide, Iron Oxide Red, NaOH, HCl | 汞含量 |
| D-Mannitol | 鎳含量 |
| Talc | 鎂、鐵、鉛、鈣及鋁含量 |
| Magnesium Carbonate | 鈣限量 |
| 食用黃色四號(Tartrazine) | 鐵、鉻及鋅含量 |
| 食用黃色五號鋁麗基(Sunset Yellow FCF Aluminum Lake) | 鐵及鋅含量 |
| Bisbentiamine, Lidocaine, Diphenhydramine HCL | 溶劑殘留 |
| Carbomer | Benzene含量 |
| Sucralose | Methanol含量 |
| Guaifenesin | 乙醇溶劑殘留 |
| Cephalexin | Dimethylaniline限量 |
| Voriconazole | Related Compound F含量 |
| Docetaxel | Acetic acid含量 |
| 95%乙醇 | 有機不純物 |
| Thiamine Mononitrate、Bismuth Subgallate、Bismuth Subcarbonate、Diphenhydramine HCl及Trisodium Citrate Dihydrate | 溶劑殘留及元素不純物 |
| Dexamethasone | Residual Solvents及Organic Impurities |
| Orlistat | Residual Solvents及Impurities |
| Tadalafil | 不纯物(Methylamine、Chloroacetic acid) |
| Polysorbate 80 | 黏度 |
| Sucrose | TLC鑑別 |
| Lactose | 旋光度及水分測定 |
| Gentamicin Sulfate | 主要活性成分比 |
| 冬青油(Methyl salicylate)、薄荷腦(Menthol)及樟腦(Camphor) | 含量測定 |
| Pentosan polysulfate sodium | Limit viscosity number, Organic and total sulfur, Sodium sulfate, Pentoses, Uronic acid, Bound and free pyridine |
| Hydrochloric Acid (exp.) | 1. Identification 2. Purity (Sulfate、Sulfite、Bromide or Iodide、Bromine or Chlorine、Heavy Metals) 3. AA / Purity (Arsenic、Mercury) 4. Residue on Ignition 5. Assay |
| Tween 20 | 1. Identification 2. GC-FID / Identification 3. Viscosity 4. Specific Gravity 5. pH 6. Acid Value 7. Saponification value 8. Purity (Heavy metals) 9. AA / Purity (Arsenic) 10. Residue on Ignition 11. Karl-Fischer / 水分 |
| ME-200AL (20 k PEG) | 1. HPLC / 20 k Fraction、Terminal activity 2. GC-FID / Organic volatile impurities 3. HPLC / BHT content 4. Bacterial Endotoxins |
| Sorbitol | 1. Identification 2. Purity (Clarity and color of solution、 Acidity or alkalinity、Chloride、Sulfate、Heavy metals、Nickel、Glucose、Sugars) 3. AA / Purity (Arsenic) 4. Loss on Drying 5. Residue on Ignition 6. Assay |
| Polyoxyl 40 Hydrogenated Castor oil | 鎳之限度試驗 |
| D-Mannitol | 鎳之限度試驗 |
| Vitamin U Chloride | 殘留溶劑(Methanol含量) |
| Dexamethasone sodium phosphate (Dexamethasone-21-phosphate sodium) | 氣相層析儀(GC)/Limit of Alcohol |
| Folic Acid | 液相層析串連質譜儀(LC-MS/MS)/N10-nitrosofolic acid |
| Urokinase | ELISA/B型肝炎表面抗原HBsAg檢驗 |


















