디 칼슘 포스페이트

디 칼슘 포스페이트 화학적 특성, 용도, 생산

• 순도시험

    (1) 비소 : 이 품목을 비소시험법에 따라 시험할 때, 그 양은 4.0ppm 이하이어야 한다.

    (2) 납 : 「메타인산나트륨」의 순도시험 (2)에 따라 시험한다(4.0ppm 이하).

    (3) 카드뮴 : 「메타인산나트륨」의 순도시험 (3)에 따라 시험한다(1.0ppm 이하).

    (4) 수은 : 이 품목을 수은시험법에 따라 시험할 때, 그 양은 1.0ppm 이하이어야 한다.

    (5) 불소화물 : 이 품목 1g을 정밀히 달아 「구연산칼슘」의 순도시험 (8)에 따라 시험한다(50ppm 이하).

• 확인시험

    (1) 이 품목을 질산은시액으로 적시면 황색을 나타낸다.

    (2) 이 품목 0.1g에 초산 5mL를 가하여 끓이고 식힌 다음 여과하여 여액에 수산암모늄시액 5mL를 가할 때, 백색의 침전이 생긴다.

• 정량법

    이 품목을 건조한 다음 약 0.3g을 정밀히 달아 묽은염산 10mL에 녹여 물을 가하여 120mL로 한다. 이하「제일인산칼슘」의 정량법에 따라 정량한다.

  0.1N 과망간산칼륨용액 1mL = 6.803mg CaHPO₄

• 화학적 성질

  Anhydrous dibasic calcium phosphate is a white, odorless, tasteless powder or crystalline solid. It occurs as triclinic crystals.

• 물리적 성질

  White triclinic crystal; density 2.92 g/cm³ (anhydrous) and 2.31 g/cm³ (dihy drate); hardness 3.5 Mohs; decomposes on heating; inosluble in water and alcohol; KSP 2.7x10^-7; soluble in dilute mineral acid.

• 용도

  Replenisher (calcium); pharmaceutic aid (tablet base).

• 생산 방법

  Calcium phosphates are usually prepared by reacting very pure phosphoric acid with calcium hydroxide, Ca(OH)₂ obtained from limestone, in stoichiometric ratio in aqueous suspension followed by drying at a temperature that will allow the correct hydration state to be achieved. After drying, the coarse-grade material is obtained by means of a classification unit; the fine particle-size material is obtained by milling. Dibasic calcium phosphate, anhydrous, may also be prepared by spray-drying.

• 농업용

  Dicalcium phosphate (CaHPO₄) is made from calcium carbonate and phosphoric acid. It contains 34% citrate- soluble phosphorus pentoxide (P₂O₅). It is not commonly used as a fertilizer, but is used as a supplement to animal feed.

• Pharmaceutical Applications

  Anhydrous dibasic calcium phosphate is used both as an excipient and as a source of calcium in nutritional supplements. It is used particularly in the nutritional/health food sectors. It is also used in pharmaceutical products because of its compaction properties, and the good flow properties of the coarse-grade material. The predominant deformation mechanism of anhydrous dibasic calcium phosphate coarse-grade is brittle fracture and this reduces the strain-rate sensitivity of the material, thus allowing easier transition from the laboratory to production scale. However, unlike the dihydrate, anhydrous dibasic calcium phosphate when compacted at higher pressures can exhibit lamination and capping. This phenomenon can be observed when the material represents a substantial proportion of the formulation, and is exacerbated by the use of deep concave tooling. This phenomenon also appears to be independent of rate of compaction.
  Anhydrous dibasic calcium phosphate is abrasive and a lubricant is required for tableting, for example 1% w/w magnesium stearate or 1% w/w sodium stearyl fumarate.
  Two particle-size grades of anhydrous dibasic calcium phosphate are used in the pharmaceutical industry. Milled material is typically used in wet-granulated or roller-compacted formulations. The ‘unmilled’ or coarse-grade material is typically used in directcompression formulations.
  Anhydrous dibasic calcium phosphate is nonhygroscopic and stable at room temperature. It does not hydrate to form the dihydrate.
  Anhydrous dibasic calcium phosphate is used in toothpaste and dentifrice formulations for its abrasive properties.

• Safety Profile

  Skin and eye irritant. A nuisance dust.

• Safety

  Dibasic calcium phosphate anhydrous is widely used in oral pharmaceutical products, food products, and toothpastes, and is generally regarded as a relatively nontoxic and nonirritant material.

• 저장

  Dibasic calcium phosphate anhydrous is a nonhygroscopic, relatively stable material. Under conditions of high humidity it does not hydrate to form the dihydrate.
  The bulk material should be stored in a well-closed container in a dry place.

• Purification Methods

  Crystallise it from a near-saturated solution in 50% aqueous reagent grade phosphoric acid at 100o by filtering through fritted glass and cooling to room temperature. The crystals are filtered off, and this process is repeated three times using fresh acid. For the final crystallisation the solution is cooled slowly with constant stirring to give thin plate crystals that are filtered off on a fritted glass funnel, washed free of acid with anhydrous acetone and dry in a vacuum desiccator [Egan et al.J Am Chem Soc 78 1811 1956].

• 비 호환성

  Dibasic calcium phosphate should not be used to formulate tetracyline antibiotics.
  The surface of milled anhydrous dibasic calcium phosphate is alkaline and consequently it should not be used with drugs that are sensitive to alkaline pH. However, reports suggest there are differences in the surface alkalinity/acidity between the milled and unmilled grades of anhydrous dibasic calcium phosphate; the unmilled form has an acidic surface environment. This difference has important implications for drug stability, particularly when reformulating from, e.g. roller compaction to direct compression, when the particle size of the anhydrous dibasic calcium phosphate might be expected to change.
  Dibasic calcium phosphate dihydrate has been reported to be incompatible with a number of drugs and excipients, and many of these incompatibilities are expected to occur with dibasic calcium phosphate, anhydrous; see Calcium phosphate, dibasic dihydrate.

• Regulatory Status

  GRAS listed. Accepted as a food additive in Europe. Included in the FDA Inactive Ingredients Database (oral capsules and tablets). Included in nonparenteral medicines licensed in Europe. Included in the Canadian List of Acceptable Non-medicinal Ingredients.

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