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Monograph for Vitamin and Mineral Pharmaceutical Products Review and Approval

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Monograph for Vitamin and Mineral Pharmaceutical Products Review and Approval 維生素及礦物質製劑基準草案(英文)-980203 Monograph for Vitamin and Mineral Pharmaceutical Products Review and Approval I. Scope 1. The Vitamin and Mineral products established by this Monograph represent the single or complex, orally-taken pharmaceutical products. 2. If the daily dosage limitation of an ingredient contained in a product is exceeded the daily dosage limitation for OTC Drug, the product is classified as Prescription Drug. 3. If a product, which contains the vitamins not listed in this Monograph, or the vitamin ingredient sources or salts not listed in this Monograph, its classification is to be reviewed case by case. 4. If a product, which indication scope is beyond the indications listed for OTC Drug and Quasi Drug (Category B) in this Monograph, its classification is to be reviewed case by case. 5. The orally-taken products established by this Monograph represent dosage forms, such as Capsules, Tablets, Syrup, Solution, etc. And, such dosage form must be the approved form to be used in Vitamin and Mineral products. II. Compounding Ingredients 1. The category and potency of compounding ingredients： (1) The compounding Vitamin and Mineral ingredients established by this Monograph (also called as compound ingredients) are presented in Table I. 1 維生素及礦物質製劑基準草案(英文)-980203 (2) The Table I establishes the upper daily dosage limitation of compounding ingredients of OTC Drug or Quasi Drug (Category B). (3) If the daily dosage limitation of any ingredient in a product is exceeded the upper daily dosage limitation of Quasi Drug in Table I, the product is classified as OTC Drug. If the daily dosage limitation of any ingredient in a product is exceed the upper daily dosage limitation of OTC Drug in Table I, the product is classified as Prescription Drug. (4) If any ingredient of a product is not listed in this Monograph Table I, please submit the relevant documents to explain the relationship of that ingredient to the compound ingredient source listed in Table I, in order to verify it is not a new chemical entity. Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Vitamin A*2 Cod liver oil Active Ingredient source Active Ingredient Retinol Retinol acetate 10,000 IU 10,000IU ◎ as Vitamin A Fat Soluble Vitamin Vitamin Fat Soluble Retinol palmitate Strong cod liver oil Vitamin A fatty acid Ester in oil Vitamin A oil β-Carotene *3 Active Ingredient source Active Ingredient 10,000 IU 10,000IU ○ as Vitamin A β-Carotene 2 維生素及礦物質製劑基準草案(英文)-980203 Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation ＊4 Vitamin D source Active Ingredient Cholecalciferol (Vit. D3) 1000 IU 800 IU ◎ as Vitamin D Ergocalciferol (Vit. D2) Ergocalciferol acetate Vitamin E ＊5 d-α-Tocopherol d-α-Tocopherol acetate Active Ingredient source Active Ingredient d-α-Tocopherol succinate (d-α-Tocopheryl acid succinate) dl-α-Tocopherol 400 IU 400 IU ◎ as Vitamin E Fat Soluble Vitamin Fat Soluble dl-α-Tocopherol acetate dl-α-Tocopherol succinate (dl-α-Tocopheryl acid succinate) dl-α-Tocopherol calcium succinate （account by dl-α- Tocopherol succinate） Vitamin K Active Ingredient source Active Ingredient Phytomenadione (Vit K1, Phylloquinone、Phytonadione) Menaquinone (Vit K2) 1mg 500 μg ○ Menadione (Vit K3) Menadione sodium bisulfite (Vit K3) Vitamin B1 Benfotiamine （Benzoylthiamine as Thiamine WaterVitamin Soluble monophosphate） hydrochloride Active Ingredient source Active Ingredient Bisbentiamine（Benzoylthiamine as Thiamine disulfide） hydrochloride Bisibuthiamine 250 mg 50 mg ◎ Bisthiamine nitrate（Thiamine as Thiamine disulfide nitrate） disulfide Cocarboxylase （Thiamine pyrophosphate） Cycothiamine 3 維生素及礦物質製劑基準草案(英文)-980203 Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Dibenzoyl thiamine Dibenzoyl thiamine hydrochloride as Thiamine Dicethiamine hydrochloride hydrochloride Fursultiamine source Active Ingredient as Fursultiamine hydrochloride Fursultiamine Octotiamine Prosultiamine 250 mg 50 mg ◎ Prothiamine as Thiamine HCl or Thiamine dicetylsulfate Thiamine nitrate WaterVitamin Soluble Thiamine disulfide Thiamine hydrochloride Thiamine nitrate Vitamin B 2 Active Ingredient source Active Ingredient Riboflavin Riboflavin phosphate as Riboflavin 100 mg 100 mg ◎ Riboflavin phosphate sodium as Riboflavin Riboflavin tetrabutyrate (Riboflavin butyrate) Pantothenic acid Calcium d-pantothenate source Active Ingredient Calcium dl-pantothenate d-Panthenol 1000 mg 500 mg ◎ dl-Panthenol Sodium d-pantothenate Sodium dl-pantothenate 4 維生素及礦物質製劑基準草案(英文)-980203 Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Vitamin B6 Pyridoxal Pyridoxal hydrochloride source Active Ingredient Pyridoxal-5-phosphate （calcium salt） Pyridoxal phosphate 200 mg 80 mg ◎ Pyridoxal phosphate Sodium Pyridoxine Pyridoxine hydrochloride Pyridoxine-5-phosphate Pyridoxamine pyridoxamine-5-phosphate Vitamin B12 WaterVitamin Soluble ( Cobalamins) Cyanocobalamin Active Ingredient source Active Ingredient Hydroxocobalamin 1,000 μg 1,000 μg ◎ as Hydroxocobalamin acetate Hydroxocobal -amin Hydroxocobalamin hydrochloride Mecobalamin/ Methylcobalamin Vitamin C Ascorbic Acid Calcium ascorbate Active Ingredient source Active Ingredient Sodium ascorbate as Ascorbic 2,000 mg 1,000 mg ◎ L-Ascorbyl Palmitate Acid L-Ascorbyl Steartate Magnesium ascorbate Niacinamide ascorbate Potassium ascorbate 5 維生素及礦物質製劑基準草案(英文)-980203 Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Nicotinamide Active Ingredient source Active Ingredient WaterVitamin Soluble Niacinamide Ascorbate 500 mg 100mg ◎ Nicotinamide (Niacinamide) Nicotinic Acid、 Niacin 450 mg 100mg ◎ Folic Acid 1,000 μg 800 μg ○ Biotin 2500μg 500μg ○ Calcium Calcium Oxide Calcium Carbonate Calcium Phosphate Monobasic Calcium Phosphate Dibasic Anhydrou Calcium Phosphate Tribasic Calcium Phosphate Active Ingredient source Active Ingredient Dibasic Mineral Calcium Lactate Calcium Gluconolactate 1800mg 1800mg ◎ as Calcium Calcium L-Threonate Calcium Citrate Calcium glycerophosphate Calcium gluconate Precipitated calcium Carbonate Ostreae Testa Pulverata Haliotidis Concha Bone meal（Calcium & Phosphorus should be labeled） Calcium acetate Calcium ascorbate Calcium bisglycinate Calcium chloride 6 維生素及礦物質製劑基準草案(英文)-980203 Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Calcium chloride dehydrate Calcium chloride hexahydrate Calcium citrate malate Calcium citrate tetrahydrate Calcium fumarate Calcium glubionate Calcium glubionate monohydrate Calcium gluceptate Calcium gluconate monohydrate Calcium glutarate Calcium hydroxide Active Ingredient source Active Ingredient Calcium lactate gluconate Mineral Calcium lactate pentahydrate Calcium lactate trihydrate Calcium lactobionate dihydrate Calcium levulinate 1800mg 1800mg ◎ as Calcium Calcium levulinate dihydrate Calcium malate Calcium pidolate Calcium pyrophosphate Calcium silicate Calcium sodium lactate Calcium succinate Calcium sulfate Calcium sulfate dihydrate Coral Dolomite Oyster shell Calcium Pearl Calcium Fluoride Casein Calcium Calcium amino acid chelate Calcium Phosphate Dibasic Hydrous 7 維生素及礦物質製劑基準草案(英文)-980203 Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation source Active Ingredient Calcium Hydrogen Phosphate Dihydrate Calcium Hydrogen Phosphate Tricalcium Phosphate 1800mg 1800mg ◎ as Calcium Dicalcium Phosphate Calcium Phosphate anhydrous Chromium Chromium（III） bisglycinate （Chromic bisglycinate） Chromium（III）chloride Mineral （chromic chloride） Chromium（III）chloride hexahydrate（chromic chloride hexahydrate） Chromium（III）citrate（chromic citrate） Active Ingredient source Active Ingredient Chromium（III）diniconitinate as 500μg 200μg ○ （chromic dinicontinate） Chromium Chromium（III）-enriched yeast （chromic-enriched yeast） Chromium（III）fumarate （chromic fumarate） Chromium（III） glutarate （chromic glutarate） Chromium（III） HAP chelate （chromic HAP chelate） Chromium（III） HVP chelate （chromic malate） Chromium（III） nicotinate （chromic nicotinate） Chromium（III） pidolate （chromic pidolate） Chromium（III） polynicotinate （chromic polynicotinate） Chromium（III） potassium sulfate dodecahydrate（chromic potassium sulfate dodecahydrate） 8 維生素及礦物質製劑基準草案(英文)-980203 Table I. Active ingredients and their sources OTC Drug Quasi Drug Formul Daily dosage (Category B) ation Active Ingredient Remark *1 limitation Daily dosage Rule limitation Active Ingredient source Active Ingredient Chromium（III） succinate （chromic succinate） Chromium（III） sulfate（chromic 500μg 200μg ○ as sulfate） Chromic acetate monohydrate Chromium Chromic picolinate Niacin bound chromium Chromic nitrate Copper Copper oxide Calcium copper edentate Copper（II） acetate （Cupric acetate） Copper（II）bisglycinate Mineral （Cupric bisglycinate） Copper（II）carbonate Active Ingredient source Active Ingredient （Cupric carbonate） Copper（II）chloride（Cupric chloride）
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