くえん酸三ナトリウム二水和物 化学特性,用途語,生産方法
外観
無色の結晶又は白色の結晶性の粉末
定義
本品は、クエン酸(*)のナトリウム塩であり、次の化学式で表される。
参照表示名称：クエン酸
溶解性
水に易溶 (72g/100g水, 25℃)。エタノールに難溶。水に溶けやすく、エタノールにほとんど溶けない。
用途
製薬、製剤原料。
用途
pH緩衝剤、医薬品原料、写真材料。
化粧品の成分用途
pH調整剤、キレート剤、緩衝剤、香料
効能
抗凝固薬, 緩衝剤, 矯味剤
商品名
クエン酸ナトリウム (小堺製薬); クエン酸ナトリウム水和物 (日興製薬); チトラミン (扶桑薬品工業)
確認試験
本品の水溶液(1→20)はクエン酸塩及びナトリウム
塩の定性反応〈1.09〉を呈する．
定量法
本品を乾燥し，その約0.2gを精密に量り，非水滴定用
酢酸30mLを加え，加温して溶かした後，0.1mol/L過塩素酸
で滴定〈2.50〉する(電位差滴定法)．同様の方法で空試験を行
い，補正する．
純度試験
(１) 溶状 本品1.0gを水10mLに溶かすとき，液は無色澄
明である．
(２) 塩化物 本品0.6gをとり，試験を行う．比較
液には0.01mol/L塩酸0.25mLを加える(0.015％以下)．
(３) 硫酸塩 本品0.5gをとり，水に溶かし，40mL
とする．これに希塩酸3.0mL及び水を加えて50mLとし，試
験を行う．比較液には0.005mol/L硫酸0.50mLを加える
(0.048％以下)．
(４) 重金属 本品2.5gをとり，第2法により操作し，
試験を行う．比較液には鉛標準液2.5mLを加える(10ppm以
下)．
(５) ヒ素 本品1.0gをとり，第1法により検液を調
製し，試験を行う(2ppm以下)．
(６) 酒石酸塩 本品1.0gに水2mL，酢酸カリウム試液
1mL及び酢酸(31)1mLを加え，ガラス棒で内壁をこすると
き，結晶性の沈殿を生じない．
(７) シュウ酸塩 本品1.0gに水1mL及び希塩酸3mLを加
えて溶かし，エタノール(95)4mL及び塩化カルシウム試液
0.2mLを加え，1時間放置するとき，液は澄明である．
(８) 硫酸呈色物 本品0.5gをとり，試験を行う．
ただし，90℃で1時間加熱する．液の色は色の比較液Kより
濃くない．
貯法
容器 気密容器．
乾燥減量
10.0～13.0％(1g，180℃，2時間)．
化学的特性
white powder or colourless crystals
使用
Trisodium citrate dihydrate, is widely applied in food, beverages and fillers as a buffering, sequestering or an emulsifying agent. It used as an anticoagulant in blood transfusions, osmotic laxative, functional fluids, solvents cleaning, furnishing care products, laundry dishwashing products and cleaning automobile radiators.
調製方法
Sodium citrate is prepared by adding sodium carbonate to a
solution of citric acid until effervescence ceases. The resulting
solution is filtered and evaporated to dryness.
定義
ChEBI: The dihydrate of trisodium citrate.
一般的な説明
Sodium citrate tribasic dihydrate is the tribasic dihydrate sodium salt of citric acid.
応用例（製薬）
Sodium citrate, as either the dihydrate or anhydrous material, is
widely used in pharmaceutical formulations.
It is used in food products, primarily to adjust the pH of
solutions. It is also used as a sequestering agent. The anhydrous
material is used in effervescent tablet formulations. Sodium citrate
is additionally used as a blood anticoagulant either alone or in
combination with other citrates such as disodium hydrogen citrate.
Therapeutically, sodium citrate is used to relieve the painful
irritation caused by cystitis, and also to treat dehydration and
acidosis due to diarrhea.
生物活性
Commonly used laboratory reagent
安全性
After ingestion, sodium citrate is absorbed and metabolized to
bicarbonate. Although it is generally regarded as a nontoxic and
nonirritant excipient, excessive consumption may cause gastrointestinal
discomfort or diarrhea. Therapeutically, in adults, up to
15 g daily of sodium citrate dihydrate may be administered orally, in
divided doses, as an aqueous solution to relieve the painful irritation
caused by cystitis.
Citrates and citric acid enhance intestinal aluminum absorption
in renal patients, which may lead to increased, harmful serum
aluminum levels. It has therefore been suggested that patients with
renal failure taking aluminum compounds to control phosphate
absorption should not be prescribed citrate- or citric acid-containing
products.
貯蔵
Sodium citrate dihydrate is a stable material. Aqueous solutions
may be sterilized by autoclaving. On storage, aqueous solutions may cause the separation of small, solid particles from glass
containers.
The bulk material should be stored in an airtight container in a
cool, dry place.
純化方法
Crystallise the salt from warm water by cooling to 0o. [Beilstein 3 III 1100, 3 IV 1274.]
不和合性
Aqueous solutions are slightly alkaline and will react with acidic
substances. Alkaloidal salts may be precipitated from their aqueous
or hydro-alcohol solutions. Calcium and strontium salts will cause
precipitation of the corresponding citrates. Other incompatibilities
include bases, reducing agents, and oxidizing agents.
規制状況(Regulatory Status)
GRAS listed. Accepted for use as a food additive in Europe.
Included in the FDA Inactive Ingredients Database (inhalations;
injections; ophthalmic products; oral solutions, suspensions, syrups
and tablets; nasal, otic, rectal, topical, transdermal, and vaginal preparations). Included in nonparenteral and parenteral medicines
licensed in the UK. Included in the Canadian List of Acceptable
Non-medicinal Ingredients.
くえん酸三ナトリウム二水和物 上流と下流の製品情報
原材料
準備製品