Calcium Silicate

Basic Information

Name: Calcium Silicate

CAS No: Calcium silicate [1344-95-2]

Functional Categories

Adsorbent Anticaking agent Opacifier Tablet filler

1. Nonproprietary Names

USP-NF: Calcium Silicate

2. Synonyms

Calcium hydrosilicate; calcium metasilicate; calcium monosilicate; calcium polysilicate; Micro-Cel; okenite; silicic acid, calcium salt; tobermorite

3. Chemical Name & CAS Registry

Calcium silicate [1344-95-2]

4. Empirical Formula & Molecular Weight

CaSiO3 116.2

5. Structural Formula

See Section 4.

6. Applications

Calcium silicate is used as a filler aid for oral pharmaceuticals. It has also been used in pharmaceutical preparations as an antacid. The main applications of calcium silicate relate to its anticaking properties, and it has therefore been used in dusting powders and a range of different cosmetic products (e.g. face powders, eye shadow).(1)

7. Description

Calcium silicate occurs as a crystalline or amorphous white or offwhite material, and often exists in different hydrate forms.

8. Pharmacopeial Specifications

The USP32–NF27 describes the material as containing not less than 4% of calcium oxide and not less than 35% of silicon dioxide. See Table I.

9. Typical Properties

Acidity/alkalinity pH = 8.4–10.2 (5% w/v aqueous solution) Density 2.10 g/cm3 Melting point 15408C Solubility Practically insoluble in water; forms a gel with mineral acids. It can absorb up to 2.5 times its weight of liquids and still remain a free-flowing powder.

10. Stability & Storage

Calcium silicate is chemically stable and nonflammable, but it should be protected from moisture. Store in airtight containers in a cool, dry place.

12. Method of Manufacture

Calcium silicate is a naturally occurring mineral, but for commercial applications it is usually prepared from lime and diatomaceous earth under carefully controlled conditions

13. Safety

When used in oral formulations, calcium silicate is practically nontoxic. Inhalation of the dust particles may cause respiratory tract irritation.

14. Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of the material handled. In large quantities, calcium silicate is irritating to eyes, the respiratory system and skin. Gloves, eye protection, a respirator, and other protective clothing should be worn. In the UK, the long-term (8-hour TWA) workplace exposure standards for calcium silicate are 10 mg/m3 for total inhalable dust and 4 mg/m3 for respirable dust.(2)

15. Regulatory Status

GRAS listed. Included in the FDA Inactive Ingredients Database (oral dosage forms). Included in nonparenteral (oral, orodispersible, effervescent and enteric-coated tablets) formulations licensed in the UK.

16. Related Substances

Calcium diorthosilicate; calcium trisilicate Studies utilizing the porous properties of calcium silicate granules have shown their ability to form floating structures, giving rise to potentially gastroretentive formulations.(3,4) A specification for calcium silicate is contained in the Food Chemicals Codex (FCC).(5) The EINECS number for calcium silicate is 215-710-8. The PubChem Compound ID (CID) for calcium silicate is 518851.

17. Comments

Studies utilizing the porous properties of calcium silicate granules have shown their ability to form floating structures, giving rise to potentially gastroretentive formulations.(3,4) A specification for calcium silicate is contained in the Food Chemicals Codex (FCC).(5) The EINECS number for calcium silicate is 215-710-8. The PubChem Compound ID (CID) for calcium silicate is 518851.