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Excipient monograph · مونوگراف ماده جانبی
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Calcium phosphate, dibasic anhydrous
دیکلسیم فسفات انیدر
1Nonproprietary names
- BPAnhydrous Calcium Hydrogen Phosphate
- JPAnhydrous Dibasic Calcium Phosphate
- Ph. Eur.Calcium Hydrogen Phosphate, Anhydrous
- USP–NFAnhydrous Dibasic Calcium Phosphate
2Synonyms and trade names
A-TAB; Anhydrous Emcompress; calcium hydrogen orthophosphate; calcium monohydrogen phosphate; dicalcium orthophosphate; DI-CAFOS AN; Fujicalin; phosphoric acid calcium salt (1:1); E341(ii)
3Chemical name and CAS Registry Number
Calcium hydrogen phosphate · [7757-93-9]
UNII L11K75P92J · PubChem CID 24441
4Empirical formula and molecular weight
CaHPO4 · 136.06
5Functional category
Diluent (filler)
Typical concentrations: — · Dosage forms: Solid
6Applications in pharmaceutical formulation
Used as a diluent and filler in tablets and capsules, in both direct compression and wet granulation; coarse or porous grades flow well and are designed for direct compression and can form a large part of the tablet. It is also used as an abrasive in toothpastes, as a calcium and phosphorus source in nutritional supplements, and in foods.
7Description
A white, odourless and tasteless powder or crystalline solid. Commercial grades range from fine powders to coarse granules and porous, spray-dried particles.
8Typical properties
- Solubility
- practically insoluble in water and ethanol; soluble in dilute hydrochloric and nitric acids
- Loss on ignition
- 6.6–8.5% w/w (from conversion to calcium pyrophosphate)
- Hygroscopicity
- non-hygroscopic; does not hydrate to the dihydrate under normal storage conditions
- Crystal form
- triclinic (monetite)
- Compaction behaviour
- consolidates mainly by brittle fracture; relatively insensitive to lubricant level and tableting speed
9Stability and storage conditions
Stable and non-hygroscopic at room temperature. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Calcium salts reduce the bioavailability of tetracycline antibiotics. The particle surface is slightly alkaline, so it may be unsuitable for drugs that degrade in an alkaline microenvironment.
11Method of manufacture
Made by reacting phosphoric acid with calcium hydroxide or calcium carbonate under controlled conditions and drying the precipitate, or by dehydrating the dihydrate; the conditions of precipitation and drying determine particle size and porosity.
12Safety
Widely used in oral pharmaceuticals, foods and toothpastes and regarded as non-toxic and non-irritant.
13Handling precautions
Observe normal precautions for the quantity handled. Avoid inhaling the dust; eye protection, gloves and a dust mask are recommended.
14Regulatory status
GRAS listed. Accepted as a food additive in Europe (E341(ii)). Included in the FDA Inactive Ingredient Database (oral capsules and tablets) and in non-parenteral medicines licensed in Europe.
15Related substances
Calcium phosphate, dibasic dihydrate; calcium phosphate, tribasic; calcium carbonate.
16Comments
Unlike the dihydrate, the anhydrous form contains no water of crystallisation, so it is preferred for moisture-sensitive drugs and for processes involving heat. Being insoluble, tablets with a high content may need a disintegrant; the material is also fairly abrasive to tooling.