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Calcium Sulfate Anhydrous, Calcium Sulfate, Calcium Sulfate Anhydrite, E516, 7778-18-9

Calcium Sulfate Anhydrous, Calcium Sulfate, Calcium Sulfate Anhydrite, E516, 7778-18-9

CALCIUM SULFATE ANHYDROUS (CaSO₄, E516)

1. Chemical Identity and Material Classification

  • Chemical Name: Calcium Sulfate Anhydrite

  • Synonyms: Calcium Sulfate Anhydrous, Anhydrite, Drierite, Anhydrous Calcium Sulfate, Calcium Sulfate (Anhydrous)

  • CAS Number: 7778-18-9

  • EC Number (EINECS): 231-900-3

  • Molecular Formula: CaSO₄

  • Molecular Weight: 136.14 g/mol

  • E Number: E516 (food additive)

  • Chemical Class: Inorganic salt, sulfate, alkaline earth metal salt

  • HS Code: 2833.27

  • UN Number: Not applicable (not classified as hazardous material)

2. Physical Properties

2.1 General Physical Properties

Property Value
Appearance White, odorless, crystalline or powder solid
Physical state (20°C) Solid (powder or crystalline)
Odor Odorless
Taste Slightly bitter, characteristic
Density (20°C) 2.96 g/cm³ (crystalline form)
Bulk density 0.9–1.2 g/cm³ (powder form)
Melting point 1,460°C (decomposes)
Boiling point Decomposes (CaO + SO₃)
Flash point Not applicable (non-flammable)
Autoignition temperature Not applicable (non-flammable)
pH (10% aqueous suspension, 25°C) 6.0–7.5 (neutral to slightly acidic)
Mohs hardness 3.0–3.5

2.2 Solubility Properties

Solvent Temperature Solubility
Water 25°C Approximately 0.20–0.30 g/100 mL (2.0–3.0 g/L)
Water 50°C Approximately 0.25 g/100 mL
Water 100°C Approximately 0.16 g/100 mL (inverse solubility – decreases with increasing temperature)
Ethanol 25°C Practically insoluble
Methanol 25°C Practically insoluble
Acetone 25°C Insoluble
Acid solutions (HCl, HNO₃) 25°C Limited to moderate solubility
Solubility in water (as Ca²⁺ and SO₄²⁻) 15–20 meq/L (forms hard water)

Important Note: Calcium sulfate exhibits inverse solubility – solubility decreases as temperature increases. This is an important property for applications such as gypsum board and cement.

2.3 Particle Characterization

Parameter Typical Value
Particle size (D50) 5–50 µm (depends on grinding grade)
Specific surface area (BET) 1–10 m²/g
Bulk density (loose) 0.9–1.1 g/cm³
Bulk density (tapped) 1.1–1.3 g/cm³
Compressibility index 15–25 (good flowability)
Hausner ratio 1.1–1.3

2.4 Hygroscopicity and Moisture Absorption

Parameter Value
Hygroscopicity Moderate – absorbs moisture at 30–50% relative humidity (converts to dihydrate)
Moisture content (Karl Fischer, as-supplied) ≤1.5% (anhydrous form)
Equilibrium moisture content (25°C, 50% RH) ~2–3% (partial hydration)
Moisture absorption rate Slow to moderate

3. Chemical Properties

3.1 Molecular Structure

  • Structure: Ca²⁺ [SO₄]²⁻

  • Crystal system: Orthorhombic (anhydrite form) – different from dihydrate (monoclinic)

  • Bond type: Ionic

  • Water content: None (anhydrous)

  • Calcium content: 29.44% Ca (by weight)

  • Sulfate content: 70.56% SO₄ (by weight)

  • Water of crystallization: 0 mol H₂O

3.2 Thermal Properties

Parameter Value
Thermal stability Stable up to 1,200°C
Decomposition onset ~1,200°C
Decomposition reaction CaSO₄ → CaO + SO₃ (≥1,200°C)
Mass loss (up to 1,200°C) 0–1% (anhydrous form)
Conversion to dihydrate (with moisture) CaSO₄ + 2H₂O → CaSO₄·2H₂O (slow)
Conversion enthalpy Exothermic (moisture absorption)
Specific heat capacity (Cp, 25°C) 0.72 J/g·K

3.3 Chemical Reactivity

Reaction / Behavior Description
Hydration with water Slow hydration → calcium sulfate dihydrate (CaSO₄·2H₂O)
Reaction with acids Partially soluble in HCl, HNO₃ → calcium salts + sulfuric acid
Reaction with bases Insoluble in dilute bases; slow reaction with concentrated bases
Reaction with reducing agents (C, H₂, CO) Forms CaS (calcium sulfide) at high temperature
Reaction with oxidizing agents Stable; no reaction
Complex formation Forms complexes with chelating agents such as EDTA (calcium titration)
Precipitation reactions Sulfate ion (SO₄²⁻) precipitates with barium (Ba²⁺) or lead (Pb²⁺) (BaSO₄)

3.4 pH and Ionic Properties

Parameter Value
Aqueous solution pH (saturated, 25°C) 6.0–7.5 (neutral to slightly acidic)
Solubility product (Ksp, 25°C) 4.93 × 10⁻⁵ (mol²/L²)
Calcium ion activity (saturated solution) ~15–20 meq/L
Sulfate ion activity (saturated solution) ~15–20 meq/L

3.5 Radiological Properties

Parameter Value
Natural radioactivity Trace amounts (uranium, thorium – depends on source)
Typical value for gypsum board ≤10 Bq/kg (considered safe)

4. Calcium Sulfate Types and Comparison

Property Anhydrous (Anhydrite) Hemihydrate (Plaster of Paris) Dihydrate (Gypsum)
CAS Number 7778-18-9 10034-76-1 10101-41-4
Formula CaSO₄ CaSO₄·½H₂O CaSO₄·2H₂O
Water content 0% ~6.2% ~20.9%
Molecular weight 136.14 g/mol 145.15 g/mol 172.17 g/mol
Appearance White powder/crystal White powder White powder/crystal
Density (g/cm³) 2.96 2.63 2.32
Solubility in water (25°C) ~0.20 g/100 mL ~0.24 g/100 mL ~0.26 g/100 mL
Common name Anhydrite, Drierite Plaster of Paris Gypsum
Mohs hardness 3.0–3.5 1.5–2.0 1.5–2.0
Thermal stability Up to 1,200°C Converts to anhydrite at 100–150°C Converts to hemihydrate at 50–120°C
Setting mechanism Slow hydration with water Rapid hydration with water → dihydrate Does not set with water (already hydrated)
Major uses Desiccant, food additive (E516), pharmaceutical filler Construction (fast-setting plaster), molding Gypsum board, plaster, agriculture (soil conditioner)

5. Commercial Grades and Specifications

Grade Purity Particle Size Major Applications
Technical Grade ≥90% 50–200 µm Construction, cement additive, gypsum board
Food Grade (E516) ≥99% 10–100 µm Food additive (acidity regulator, flour treatment agent)
Pharmaceutical Grade (USP/NF, Ph.Eur) ≥99.5% 5–50 µm Filler for tablets and capsules (excipient)
Laboratory Grade (Drierite) ≥99.5% (anhydrous) 4–20 mesh, 8–30 mesh Desiccant agent (desiccator), gas drying
High Purity (Analytical) ≥99.99% 1–20 µm Analytical chemistry reference standards

6. Quality Specifications (Food Grade – E516)

Parameter Specification (Food Grade) Test Method
Assay (CaSO₄, dry basis) ≥99.0% Gravimetric (sulfate)
Loss on drying (200°C) ≤1.5% Gravimetric
Acid-insoluble substances ≤0.05% Gravimetric
Chlorides (Cl) ≤0.01% Turbidimetric
Fluorides (F) ≤0.003% (30 ppm) Ion-selective electrode
Heavy metals (as Pb) ≤0.001% (10 ppm) Colorimetric
Arsenic (As) ≤2 ppm Atomic absorption
Lead (Pb) ≤2 mg/kg Atomic absorption
Cadmium (Cd) ≤1 mg/kg Atomic absorption
Mercury (Hg) ≤1 mg/kg Atomic absorption
Iron (Fe) ≤0.01% Colorimetric
Alkalinity (as Na₂CO₃) ≤0.05% Titration
pH (10% suspension) 6.0–7.5 pH meter
Calcium content (Ca) 27–31% Complexometric (EDTA)
Sulfate content (SO₄) 68–71% Gravimetric

7. Production Methods

7.1 Natural Source Production (Mining)

  • Source: Natural anhydrite deposits (anhydrite rock)

  • Process:

    1. Open-pit or underground mining

    2. Crushing and grinding

    3. Classification (sieving, air separation)

    4. Purification (removal of impurities such as clay, carbonates)

    5. Drying (to remove moisture)

  • Purity: 90–98%

  • Cost: Low

7.2 Production by Calcination of Dihydrate (Gypsum)

  • Reaction: CaSO₄·2H₂O → CaSO₄ (anhydrite) + 2H₂O

  • Process:

    1. Natural gypsum (dihydrate) is collected

    2. Crushed and ground

    3. High-temperature calcination: 300–800°C (depending on type)

      • 300–500°C → Soluble anhydrite (higher solubility in water)

      • 500–800°C → Insoluble anhydrite (low solubility, stable)

      • 800°C → Dead-burned anhydrite (very slow hydration)

    4. Cooling and grinding

  • Purity: 95–99.5%

7.3 Chemical Precipitation Method (High Purity)

  • Reaction: CaCl₂ + H₂SO₄ → CaSO₄ + 2HCl

  • Process:

    1. Calcium chloride (CaCl₂) solution is prepared

    2. Sulfuric acid (H₂SO₄) is added

    3. Calcium sulfate precipitates

    4. Filtered, washed, dried

  • Purity: ≥99.5%

  • Use: Pharmaceutical and food grade

7.4 Production as a By-product

  • Sources:

    • Phosphate fertilizer production (phosphogypsum)

    • Flue gas desulfurization (FGD – coal power plants)

    • Salt production

  • Purity: Variable (80–95%)

  • Use: Cement and gypsum board production

8. Mechanism of Action (Functional Mechanisms)

8.1 Desiccant (Drying) Mechanism

  • Anhydrous calcium sulfate chemically binds water molecules into its crystal lattice, converting to the dihydrate form (CaSO₄·2H₂O).

  • Reaction: CaSO₄ + 2H₂O → CaSO₄·2H₂O + heat (exothermic)

  • Water holding capacity: ~20% (by weight) – theoretical maximum (2 mol water / 1 mol CaSO₄)

  • Typical moisture adsorption: 10–15% (under ambient conditions)

  • Advantages:

    • High water holding capacity

    • Reusable (can be re-dried at 200°C)

    • Non-toxic

    • Inexpensive

  • Limitations:

    • Slower moisture adsorption compared to silica gel or molecular sieves

    • Less effective at low humidity levels (<10% RH)

8.2 Binder Mechanism in Cement and Plaster

  • When anhydrite is mixed with water, it slowly hydrates to the dihydrate form (CaSO₄·2H₂O).

  • The dihydrate forms needle-like crystals (monoclinic), causing the mixture to harden and gain strength.

  • Reaction rate: Slow (days to weeks) – much slower than hemihydrate (minutes to hours).

  • In cement, anhydrite acts as a set retarder – prevents flash set (rapid hardening).

8.3 Acidity Regulator Mechanism (Food – E516)

  • Partially dissolves in water, creating a slightly acidic environment (pH 6.0–7.5).

  • Calcium ions (Ca²⁺) form complexes with anionic compounds, providing a buffering effect.

  • In flour treatment, activates or inhibits naturally occurring enzymes (amylase, protease).

  • In beer production, regulates water hardness and promotes yeast flocculation.

8.4 Flour Treatment Agent Mechanism (E516)

  • Regulates the pH of flour, stabilizing the gluten structure.

  • Calcium ions promote cross-linking between gluten proteins.

  • Results: Better dough elasticity, higher bread volume, improved crumb structure.

8.5 Tablet Filler Mechanism (Pharmaceutical)

  • An inert, poorly water-soluble filler.

  • Provides bulk and mechanical strength to tablets.

  • Used as an alternative to sugar-based fillers such as lactose (lower hygroscopicity).

  • Does not significantly affect tablet disintegration.

9. Applications

9.1 Construction and Building Materials – Largest Application (~70%)

Application Function Typical Concentration
Cement additive (set retarder) Controls setting time, prevents flash set 3–8% (of cement weight)
Gypsum board (drywall) core Binder, fire resistance, sound insulation 20–30% (of dry mix)
Self-leveling floor compounds Flow regulator, strength enhancer 10–20%
Plasters and mortars Binder, set control 2–10%
Gypsum blocks and bricks Binder 50–90%
Fire-resistant coatings Passive fire protection 10–30%

9.2 Food Industry (E516)

Application Function Typical Concentration Regulatory Status
Flour treatment agent Gluten strengthener, dough conditioner 0.1–0.5% (of flour weight) FDA GRAS, EFSA approved
Bread and bakery products pH regulator, nutritional supplement (calcium) 0.1–0.3% FDA GRAS, EFSA approved
Beer production Water hardness regulator, yeast flocculation 0.1–0.5 g/L (before yeast pitching) FDA GRAS, EFSA approved
Acidity regulator (canned foods, jams) pH buffering 0.1–0.5% FDA GRAS, EFSA approved
Nutritional supplement (calcium source) Calcium fortification Variable (product dependent) FDA GRAS, EFSA approved
Confectionery (chewing gum, candies) Filler, anti-caking agent 0.5–2% FDA GRAS, EFSA approved
Tofu production (coagulant) Coagulates soy milk 0.2–0.5% Common (especially in Asia)

Regulatory Note: E516 is permitted as a food additive in the EU and Turkey. The acceptable daily intake (ADI) is "not specified" – considered safe. As a flour treatment agent, it is limited to a maximum of 0.5% (5000 ppm).

9.3 Laboratory and Analytical Chemistry

Application Function Typical Amount
Desiccator drying agent (Drierite) Moisture absorption, gas drying 200–500 g/desiccator
Gas drying columns Drying of nitrogen, air, hydrogen, carbon dioxide 10–50 cm (column height)
Liquid drying (solvents) Water removal from organic solvents 50–100 g/L solvent
Analytical reagent Reference for calcium and sulfate determinations Variable
Chemical reagent carrier Catalyst support 5–10%

About Drierite: Drierite is a registered trademark of calcium sulfate anhydrous. It is available in blue (anhydrous, turns pink when wet) or white (indicator-free) forms. Moisture capacity is ~15–20%. It can be reactivated at 200°C.

9.4 Pharmaceutical Industry

Application Function Typical Concentration
Tablet filler (excipient) Bulking agent, binder 5–20% (depending on formulation)
Capsule filler Inert carrier 10–30%
Effervescent tablets Acid source (with citric or tartaric acid) 10–30%
Toothpaste Abrasive, polishing agent 10–30%
Topical powders Absorbent, lubricant 20–50%
Packaging desiccant (pharmaceutical vials) Moisture absorption (product stability) 1–5 g/unit

Pharmacopoeia Compliance:

  • USP: Calcium Sulfate Anhydrous (USP–NF)

  • Ph.Eur: Calcii sulfas anhydricus

  • JP: Calcium Sulfate Hydrate (anhydrous form not included – dihydrate is used)

9.5 Agriculture

Application Function Typical Amount
Soil conditioner (alternative to liming) Raises soil pH, provides calcium and sulfate 200–500 kg/hectare
Calcium fertilizer Calcium source for plants (cell wall strength) 100–300 kg/hectare
Sulfate fertilizer Sulfur source for plants (amino acid synthesis) 100–300 kg/hectare
Animal feed additive Calcium and sulfur supplement 0.5–2% (of feed weight)
Compost additive Ammonia absorption, odor control 5–10%
Mushroom cultivation (compost additive) pH regulator, nutrient source 2–5%

9.6 Ceramics and Glass Industry

Application Function Typical Concentration
Ceramic mold making (plaster molds – not anhydrite) Anhydrite is not directly used; hemihydrate is preferred
Glass manufacturing (flux regulator) Lowers melting temperature, increases fluidity 2–5% (of glass batch)
Glaze preparation (ceramic glazes) Opacifier, matting agent 5–15%
Investment casting powders Binder 10–20%

9.7 Polymer, Plastic, and Paint Industry

Application Function Typical Concentration
Plastic filler (PP, PE, PVC) Cost reducer, hardness enhancer, dimensional stability 5–20%
Rubber filler Hardness enhancer, abrasion resistance 10–30%
Paints and coatings (filler) Matting agent, viscosity regulator 5–15%
Inks Filler, white pigment (reduces transparency) 5–10%
Adhesives and putties Filler, viscosity regulator 10–20%

9.8 Paper Industry

Application Function Typical Concentration
Paper filler Opacity, brightness, printability 5–15% (of paper weight)
Paper coating Smooth surface, ink absorption 10–20%
Cardboard (filler) Stiffness, strength 5–10%

9.9 Other Industrial Applications

Application Function
Wastewater treatment Phosphate removal, heavy metal precipitation
Paint recovery (coagulant) Coagulation of paint particles
Oil and gas (mud weighting) Weighting material in drilling mud
Fire extinguishers (powder type) Flame retardant (additive in ABC powders)
Foundry industry (sand binder) Binder in foundry molds

10. Toxicology and Safety

10.1 Acute Toxicity

Parameter Value Classification
Oral LD₅₀ (rat) >5,000 mg/kg Not classified
Dermal LD₅₀ (rabbit) >2,000 mg/kg Not classified
Inhalation LC₅₀ (rat, 4 hr) >2 mg/L (dust) Not classified
Skin irritation Mild irritant (dust) Not classified
Eye irritation Mild to moderate irritant (dust, mechanical) Not classified
Skin sensitization Non-sensitizer Not classified

10.2 Subchronic and Chronic Toxicity

Parameter Value
NOAEL (rat, 90 day) 4,000 mg/kg/day (practically non-toxic)
Reproductive toxicity Negative
Developmental toxicity Negative
Genotoxicity (Ames test) Negative
Carcinogenicity Negative (not classified)
Target organ toxicity (repeated) None (relatively inert)

10.3 Special Concerns and Considerations

Concern Information
Inhalation (dust) Mechanical respiratory tract irritation with prolonged exposure; not fibrogenic
Dust explosion risk Low (inorganic, non-flammable)
Calcium load (excessive intake) Very high doses may cause gastrointestinal discomfort, constipation
Allergenicity Not known as an allergen
Radioactivity Trace amounts depending on natural source (<10 Bq/kg)
Food additive limits EFSA: ADI not specified; FDA: GRAS; Turkish Food Codex: Subject to relevant regulations

10.4 GHS Classification (Generally not classified – but for dust form)

Classification Category (dust form)
Signal word Warning (in case of dust inhalation or eye contact)
Hazard statements H319 – Causes serious eye irritation (dust). H335 – May cause respiratory tract irritation (dust).
Precautionary statements P261, P264, P271, P280, P304+P340, P305+P351+P338, P312, P337+P313

Note: Calcium sulfate anhydrous is considered safe (GRAS) by major regulatory authorities (FDA, EFSA).

10.5 NFPA Rating

Health Flammability Reactivity Special
1 0 0 None

11. Safety Precautions and Personal Protective Equipment (PPE)

Hazards:

  • Respirable dust: Prolonged exposure may cause respiratory tract irritation (mechanical).

  • Eye irritation: Dust causes mechanical eye irritation.

  • Non-flammable: No fire risk.

  • Chemical reactivity: Low; may react with strong acids or reducing agents at high temperatures.

PPE (mandatory – for dust form):

  • Respiratory protection: P1 or P2 filter mask (to prevent dust inhalation). FFP2/N95 in enclosed areas without dust control.

  • Eye protection: Dust-tight safety goggles (not chemical splash goggles – dust goggles).

  • Gloves: Nitrile or latex gloves (for basic contact – chemical risk is low).

  • Protective clothing: Dust-proof laboratory coat.

  • Footwear: Closed-toe work shoes.

Engineering controls:

  • Local exhaust ventilation (LEV) with dust collection.

  • Regular cleaning to prevent dust accumulation.

  • Dust control during bag opening and transfer operations (dust cover, closed system).

Storage conditions:

  • Store in original, closed packaging (polyethylene bag, box, sack).

  • Store in a cool, dry, well-ventilated area (10–30°C).

  • Protect from moisture (hygroscopic – converts to dihydrate, cakes).

  • Keep away from acids and reducing agents.

  • Store on racks or pallets (prevent floor contact).

  • Shelf life: 2–5 years under proper conditions (degradation signs: caking, partial hydration).

Firefighting:

  • Fire class: Not applicable (non-flammable). Use extinguishing media appropriate for surrounding fire.

  • Extinguishing media: Dry chemical powder, CO₂, water spray, foam.

  • Special hazards: Non-flammable; at high temperatures (>1,200°C) decomposes to produce toxic SO₃ (sulfur trioxide) fumes.

First aid:

  • Inhalation: Move to fresh air; seek medical attention if respiratory distress persists.

  • Skin contact: Wash with plenty of water and soap.

  • Eye contact: Rinse with plenty of water for at least 15 minutes (lifting eyelids); remove contact lenses; seek medical attention if irritation persists.

  • Ingestion: Rinse mouth; drink plenty of water; seek medical attention if large amounts are swallowed (generally non-toxic).

Environmental precautions:

  • Do not discharge directly into water sources or sewers.

  • Not biodegradable (inorganic); persists in the environment.

  • May cause physical pollution (insoluble in water).

  • Dispose preferably by landfill (inert waste).

12. Environmental Fate

Parameter Value
Biodegradability Not applicable (inorganic)
Aquatic toxicity (fish, LC₅₀, 96 hr) >1,000 mg/L (low toxicity)
Daphnia magna (EC₅₀, 48 hr) >1,000 mg/L
Algal toxicity (EC₅₀, 72 hr) >500 mg/L
Bioaccumulation Not applicable (inorganic)
Mobility in soil Low (poorly soluble in water, remains in soil)
Degradation in water Does not hydrolyze (stable)
Acid rain effect Slowly dissolves as calcium and sulfate ions
Soil acidification Neutral; provides buffering effect in acidic soils
WGK Germany 1 (low hazard to water)
Disposal method Landfill (inert waste)

13. Storage and Shelf Life

13.1 Storage Conditions

Parameter Requirement
Storage temperature 10–30°C (cool, room temperature)
Relative humidity <50% (to prevent hydration and caking)
Container type Polyethylene bag (inner), cardboard box or sack (outer)
Package sizes 10 kg, 20 kg, 25 kg (bag/box); 500 kg (big bag); 1 ton (bulk sack)
Protect from Moisture, high temperature (accelerates hydration), acids, reducing agents
Environment Dry, well-ventilated, dust-free

13.2 Shelf Life and Degradation

Parameter Value
Shelf life (unopened, proper conditions) 2–5 years
Shelf life (after opening) 6–12 months (if properly resealed)
Degradation signs Caking (clumping); weight gain (moisture absorption); partial dihydrate formation; reduced drying capacity (as desiccant)
Degradation mechanism Moisture absorption → formation of CaSO₄·2H₂O (gypsum); not irreversible (can be re-dried at 200°C)
Reactivation (Drierite) 2–4 hours at 200°C (in drying oven)

14. Transport Information

Regulation Classification
UN Number Not applicable (not classified as hazardous material)
ADR/RID Not classified (not dangerous goods)
IMDG Not classified
IATA Not classified
Special precautions Dust control when transported in bulk as powder
Not subject to ADR, RID, IMDG, IATA (all forms)

Transport note: Not classified as hazardous material. When transported in large quantities (≥500 kg), precautions should be taken to prevent dust formation.

15. Synonyms and Common Names

  • English: Calcium Sulfate Anhydrous, Calcium Sulfate Anhydrite, Drierite, Anhydrous Calcium Sulfate

  • German: Calciumsulfat wasserfrei, Anhydrit

  • French: Sulfate de calcium anhydre, Anhydrite

  • Spanish: Sulfato de calcio anhidro, Anhidrita

  • Trade names: Drierite (brand), Anhydrite, Karstenite, Calcium Sulfate Anhydrous (USP/NF), Calcii sulfas anhydricus (Ph.Eur)

16. Calcium Sulfate Anhydrous vs. Dihydrate – Comparison

Property Anhydrous (7778-18-9) Dihydrate (10101-41-4)
Water content 0% ~20.9%
Molecular weight 136.14 g/mol 172.17 g/mol
Density (g/cm³) 2.96 2.32
Mohs hardness 3.0–3.5 1.5–2.0
Solubility in water (25°C) ~0.20 g/100 mL ~0.26 g/100 mL
Hygroscopicity Moderate (absorbs moisture) Not hygroscopic
Drying capacity High (desiccant) None
Food additive code E516 E516 (both)
Calcination temperature (production) 300–800°C Occurs naturally (gypsum)
Applications Desiccant, food additive, pharmaceutical filler Construction, gypsum board, agriculture
Hydration rate Slow (days/weeks) Not applicable (already hydrated)

17. Properties as a Pharmaceutical Excipient

17.1 Pharmacopoeia Compliance

Pharmacopoeia Monograph
USP (United States) Calcium Sulfate Anhydrous (USP–NF)
Ph.Eur. (Europe) Calcii sulfas anhydricus
JP (Japan) Calcium Sulfate Hydrate (anhydrous form not included – dihydrate is used)
BP (United Kingdom) Calcium Sulfate Anhydrous

Note: USP and Ph.Eur include the anhydrous form, while JP includes only the dihydrate form (Calcium Sulfate Hydrate).

17.2 Typical Formulation Concentrations (Tablets and Capsules)

Application Concentration (w/w)
Direct compression (DC) formulations (filler) 10–30%
Added after granulation (filler) 5–20%
Hard gelatin capsules (filler) 10–40%
Effervescent tablets (acid source) 10–30% (with citric/tartaric acid)
Chewable tablets 10–25%

18. Quality Control Tests (Pharmaceutical Grade)

Test Method Acceptance Criteria
Identification A (Sulfate) Precipitation with BaCl₂ White precipitate (BaSO₄)
Identification B (Calcium) Flame test or AAS Characteristic color for calcium (orange-red)
Loss on drying (200°C) Gravimetric ≤1.5%
Chloride Turbidimetric (AgNO₃) ≤0.01%
Fluoride Ion-selective electrode ≤30 ppm
Heavy metals (as Pb) Colorimetric ≤10 ppm
Lead (Pb) Atomic absorption ≤2 ppm
Cadmium (Cd) Atomic absorption ≤1 ppm
Mercury (Hg) Atomic absorption ≤1 ppm
Iron (Fe) Colorimetric ≤0.01%
Alkalinity Titration ≤0.05%
pH (10% suspension) pH meter 6.0–7.5
Calcium assay (Ca) Complexometric (EDTA) 27–31%
Sulfate assay (SO₄) Gravimetric 68–71%
Particle size (optional) Laser diffraction / sieving User-defined

19. Frequently Asked Questions (FAQs)

Q1: Is calcium sulfate anhydrous the same as gypsum?
A1: No. Anhydrous contains no water (CaSO₄), while gypsum (dihydrate) contains 2 mol of water (CaSO₄·2H₂O). Anhydrous is hygroscopic (absorbs moisture) and is used as a desiccant; gypsum is used as a construction material and soil conditioner.

Q2: Is calcium sulfate anhydrous safe in food?
A2: Yes, it is FDA GRAS and EFSA approved as a food additive under E516. It is widely used as a flour treatment agent, acidity regulator, and calcium supplement. No toxicity has been reported at typical use levels (0.1–0.5%).

Q3: Why is calcium sulfate anhydrous used as a desiccant?
A3: Anhydrous calcium sulfate chemically absorbs moisture from the air, converting to the dihydrate (CaSO₄·2H₂O). This reaction is exothermic and can hold up to ~20% of its weight in water. It is less expensive than silica gel or molecular sieves and can be reactivated (re-dried) at 200°C.

Q4: Is calcium sulfate anhydrous (E516) vegan?
A4: Yes, calcium sulfate anhydrous is a completely inorganic mineral. It is produced by mining or chemical synthesis and contains no animal-derived components. It is vegan, halal, and kosher.

Q5: Is calcium sulfate anhydrous soluble in water?
A5: It has very low solubility (~0.20 g/100 mL at 25°C). It exhibits inverse solubility – solubility decreases as temperature increases. This property is important for applications such as gypsum board and cement.

Q6: Is calcium sulfate anhydrous flammable?
A6: No, it is non-flammable. Its NFPA flammability rating is 0. However, at very high temperatures (>1,200°C), it decomposes to produce toxic SO₃ fumes.

Q7: How is calcium sulfate anhydrous used in tablets?
A7: It is used as an inert filler (excipient) in pharmaceutical tablets. It provides bulk and mechanical strength to tablets, but unlike other fillers such as lactose or microcrystalline cellulose, it has weak binding properties.

Q8: Does calcium sulfate anhydrous acidify soil?
A8: No, it is a neutral substance (pH 6.0–7.5 in 10% suspension). When used as a soil conditioner, it does not make soil alkaline like lime (calcium carbonate), but provides a source of calcium and sulfate. It may have a slight buffering effect in acidic soils.

20. Summary Table – Key Specifications at a Glance

Parameter Value
Product Name Calcium Sulfate Anhydrous (Anhydrous Calcium Sulfate)
CAS Number 7778-18-9
EC Number 231-900-3
Molecular Formula CaSO₄
Molecular Weight 136.14 g/mol
Appearance White, odorless, crystalline powder or pellets
Odor Odorless
Density (20°C) 2.96 g/cm³
Melting Point 1,460°C (decomposes)
Solubility in Water (25°C) ~0.20 g/100 mL (very low)
pH (10% suspension) 6.0–7.5 (neutral)
Calcium content 27–31% (typically 29.4%)
Sulfate content 68–71% (typically 70.6%)
Water content (anhydrous form) ≤1.5% (typical)
Loss on drying (200°C) ≤1.5% (food grade)
Heavy metals (as Pb) ≤10 ppm
Lead (Pb) ≤2 ppm
Cadmium (Cd) ≤1 ppm
E Number E516
Primary Applications Desiccant, food additive (flour treatment agent, acidity regulator), pharmaceutical filler, cement additive, soil conditioner
GHS Signal Word Warning (in case of dust inhalation/eye contact)
Hazard Statements H319 (causes serious eye irritation), H335 (may cause respiratory tract irritation)
UN Number Not applicable (not dangerous goods)
Oral LD₅₀ (rat) >5,000 mg/kg (non-toxic)
Biodegradability Not applicable (inorganic)
Shelf Life (proper conditions) 2–5 years
Pharmacopoeia compliance USP, Ph.Eur, BP (for anhydrous form)

*This TDS is prepared in compliance with ISO 11014-1 format and is intended for construction engineers, food technologists, pharmaceutical formulators, laboratory personnel, agricultural specialists, and procurement professionals. Certificates of Analysis (CoA), Safety Data Sheets (SDS), and sample validation reports are available upon request.*

 

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