Calcium sulfate dihydrate

Category

Desiccant; Diluents

Molecular Formula

CaSO4·2H2O

Molecular Weight

172.17

Grade

Pharmceutical Excipients

Description

Both calcium sulfate and calcium sulfate dihydrate are white or off-white, fine, odorless, and tasteless powder or granules.

UNII

WAT0DDB505

Chemical Name

Calcium sulfate dihydrate

CAS Number

10101-41-4

Synonyms

Calcium sulfate dihydrate alabaster; calcii sulfas dihydricus; Compactrol; Destab; E516; gypsum; light spar; mineral white; native calcium sulfate; precipitated calcium sulfate; satinite; satin spar; selenite; terra alba; USG Terra Alba.

Stability and Storage Conditions

Calcium sulfate is chemically stable. Anhydrous calcium sulfate is hygroscopic and may cake on storage. Store in a well-closed container in a dry place, avoiding heat.

Safety

Calcium sulfate dihydrate is used as an excipient in oral capsule and tablet formulations. At the levels at which it is used as an excipient, it is generally regarded as nontoxic. However, ingestion of a sufficiently large quantity can result in obstruction of the upper intestinal tract after absorption of moisture. Owing to the limited intestinal absorption of calcium from its salts, hypercalcemia cannot be induced even after the ingestion of massive oral doses. Calcium salts are soluble in bronchial fluid. Pure salts do not induce pneumoconiosis.

Incompatibilities

In the presence of moisture, calcium salts may be incompatible with amines, amino acids, peptides, and proteins, which may form complexes. Calcium salts will interfere with the bioavailability of tetracycline antibiotics.It is also anticipated that calcium sulfate would be incompatible with indomethacin, aspirin, aspartame, ampicillin, cephalexin, and erythromycin since these materials are incompatible with other calcium salts. Calcium sulfate may react violently, at high temperatures, with phosphorus and aluminum powder; it can react violently with diazomethane.