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) |