Anhydrous Citric Acid

Category

Buffer; pH regulator; Flavoring Agents; Stabilizer; Excipient; Disintegrant

Molecular Formula

C6H8O7·H2O

Molecular Weight

192.13

Grade

Pharmceutical Excipients

UNII

XF417D3PSL

Chemical Name

2-Hydroxypropane-1, 2, 3-tricarboxylic acid

CAS Number

77-92-9

Synonyms

Citric acid, anhydrous

Administration route

Oral, intravenous, eye, ear and nose, inhalation general external use

Dosage Form

Oral, intravenous, eye, ear and nose, inhalation general external use

Stability and Storage Conditions

Dilute citric acid solution can be fermented while standing. Store in air-tight container in a cool and dry place.

Source and Preparation

Citric acid occurs naturally in large quantities in plants and is extracted from lemon juice, which contains 5 to 8% citric acid, or from pear residue. Citric acid can be purified by double junction and monohydrate can be prepared from cooled concentrated aqueous solution.

Applications

Often used as buffer, pH regulator, flavor correction agent, stabilizer, excipatory agent, disintegrating agent, etc.

Safety

Citric acid is found in the human body, mostly in the bones. Usually consumed as part of a normal diet. Citric acid can be absorbed orally and is non-toxic when used as excipients. However, excessive or frequent use of citric acid can cause tooth erosion. Citrate and citrate also enhance intestinal aluminum absorption in kidney patients, resulting in an increase in harmful serum aluminum concentrations. Therefore, citrate or citrate containing products are not recommended when aluminum compounds are used to control phosphate absorption in patients with renal insufficiency. LD50 (mouse, IP): 0.9g /kg; LD50 (mouse, IV): 0.04 g/kg; LD50 (mouse, oral): 5.04g /kg; LD50 (mouse, SC): 2.7g /kg; LD50 (Rabbit, IV): 0.33g /kg; LD50 (rat, IP): 0.88 g/kg; LD50 (rat, oral): 3.0g /kg; LD50 (rat, SC): 5.5 g/kg

Incompatibilities

Citric acid is incompatibilities with potassium tartrate, basic gold rot, alkaline earth metal carbonate, bicarbonate, acetate and sulfide, as well as with oxidants, chemicals, reductants and nitrates. It may explode upon exposure to metal salts of nitric acid. During storage, sucrose can be extracted from syrups containing citric acid.