Calcium Citrate Malate NEW

1. Product Identification

• Product name: Calcium Citrate Malate

• Synonyms: CCM; Calcium citrate-malate salt; Calcium (citrate)(malate) complex

• Chemical nature: Organic calcium salt complex (combination of calcium bound to citrate and malate anions)

• Typical appearance: White to off-white free-flowing powder

• Physical form: Powder, hygroscopic tendencies vary by grade and packaging

2. Typical Chemical / Physical Properties (General)

• Elemental calcium (Ca) content (dry basis): typically 20–26% (manufacturer-specific; see grade tables below)

• Molecular formula (typical representation): complex salt of calcium with citrate and malate (stoichiometry varies with hydration)

• Odour: Odourless or very faint organic odour

• pH (1% w/v aqueous): ~4.5–7.0 (acidic to near-neutral; depends on grade and counterions)

• Solubility: Slightly soluble in water; solubility increases in acidic medium (soluble in dilute organic acids or dilute HCl)

• Bulk density (loose / tapped): ~0.4–0.8 g/mL (loose) ; tapped density ~0.8–1.3 g/mL (highly dependent on particle size and grade)

• Particle size (typical): Fine powder; commonly specified as “passes 80 mesh / 180 µm” for standard grades; finer grades ≤ 100 µm for tableting/encapsulation

• Moisture / Loss on Drying (LOD): see grade table

• Appearance by microscopy: crystalline or amorphous micro-particles depending on synthesis and drying conditions

3. Grades & Typical Specifications

A. Industrial / Technical Grade (for non-food industrial applications)

Typical specification (representative)

B. Food Grade / Dietary Supplement Grade (higher purity; suitable for food fortification / supplements)

Representative specification (for food/dietary use)

Notes: Numbers above are typical ranges used in industry. Specific claims such as “meets USP/FCC/Food Chemical Codex” require validated methods and certificates.

4. Analytical Methods / Test Procedures (recommended)

These are commonly used QC methods to verify the parameters above. Suppliers must reference validated SOPs.

• Elemental Calcium: ICP-OES / ICP-MS (preferred) or AAS (graphite furnace or flame for appropriate range). Results reported as % Ca on dry basis.

• Assay of CCM (organic content): Combination of titration and chromatographic profile. Total organic acid content (citrate + malate) may be quantified by HPLC (ion-exclusion or ion-exchange with appropriate standardization).

• Loss on Drying (LOD): Gravimetric (105 ± 2 °C to constant weight) or moisture analyser (Karl Fischer if residual water content very low).

• pH: Measure 1% w/v dispersion at 20–25 °C with calibrated pH meter.

• Heavy metals (Pb, As, Cd, Hg, total heavy metals): ICP-MS or ICP-OES following acid digestion (EPA / pharmacopeial digestion methods).

• Microbiology: Plate count methods for Total Aerobic Count, Yeast & Mold; enrichment and detection for Salmonella, E. coli per pharmacopeial microbiology methods (e.g., ISO or USP methods).

• Particle size: Laser diffraction or sieve analysis (as specified).

• Residual solvents / reagents: GC or other applicable methods if solvents used.

• Identification Tests: IR spectrum (FT-IR) to confirm characteristic organic acid salt peaks; DSC or XRD for crystalline form information (if applicable).

5. Manufacturing & Quality Control (summary)

• Raw materials: Food/pharma grade citric acid, malic acid (or their salts), food/pharma grade calcium source (e.g., calcium hydroxide or carbonate) depending on process. Suppliers must control raw material quality.

• Typical process (broad overview): Controlled neutralization/complexation of calcium with citrate and malate under aqueous conditions, concentration, purification (filtration), controlled drying (spray-dry or tray dryer), milling and sieving to target particle size, final blending and packaging.

• In-process controls: pH, Ca assay, moisture, particle size, microbial monitoring (for food grade), metal impurity checks.

• Batch traceability: Lot numbering, CoA, production date, expiry/shelf-life, manufacturing controls and retest intervals recorded.

6. Packaging, Storage & Shelf Life

• Packaging options:

• Food grade: multilayer polyethylene / foil bags (e.g., 25 kg net) with inner PE liner; small pack sizes available on request.

• Industrial grade: kraft bags with PE liner; bulk bags (FIBC) for larger volumes.

• Labeling: Product name, grade, net weight, lot/batch number, manufacture date, expiry/retest date, storage instructions, manufacturer contact, hazard labels if applicable.

• Storage conditions: Cool, dry (relative humidity <60%), away from strong oxidizers, acids, or bases; avoid direct sunlight and heat sources. Keep containers tightly closed.

• Shelf life / Retest period: Typically 24–36 months when stored under recommended conditions. For food/pharma grade, retest intervals and shelf life must be validated via stability studies; moisture uptake is a common limiting factor.

• Handling: Minimize dust generation; use local exhaust ventilation; use appropriate PPE (dust mask or respirator, safety goggles, gloves). Avoid ingestion and inhalation.

7. Safety & Regulatory (summary)

• Hazards: Product is not classified as hazardous under common transport rules in typical quantities; however, airborne dust may be an irritant to eyes, skin and respiratory tract. Avoid dust formation.

• First aid:

• Inhalation: Move to fresh air; seek medical attention if symptoms persist.

• Skin contact: Wash with soap and water.

• Eye contact: Rinse thoroughly with water for several minutes; seek medical attention if irritation persists.

• Ingestion: Rinse mouth; seek medical attention if large amounts were swallowed.

• PPE: Dust mask/respirator (NIOSH approved for nuisance dust), safety goggles, protective gloves, protective clothing.

• SDS: A Safety Data Sheet (SDS) to be provided with each shipment specifying hazard classification (if any), disposal, transport data, and precise first-aid measures.

• Regulatory statements: If marketed for food or dietary use, product must be manufactured under appropriate food-grade GMP, with microbiological and heavy metal controls compliant with target market regulations. Supplier to provide declarations for allergen cross-contact, GMO, Kosher/Halal if requested.

8. Microbiology (food grade)

• Total Plate Count (TPC): ≤ 1,000 cfu/g

• Yeasts & Molds: ≤ 100 cfu/g

• Salmonella: Absent in 25 g (or per local regulation)

• E. coli: Absent in 10 g (or per local regulation)

• Staphylococcus aureus / Listeria / other pathogens: Absent or as per customer/regulatory requirement

9. Example Certificate of Analysis (CoA) — single lot (illustrative)

• Lot / Batch no.: XYZ-2025-001

• Mfg date: 2025-01-15

• Expiry / Retest date: 2027-01-14

• Appearance: White to off-white powder — PASS

• Elemental Ca (ICP-OES): 22.6% — PASS (spec ≥ 21.0%)

• Loss on Drying (105°C): 3.8% — PASS (spec ≤ 5.0%)

• pH (1%): 6.2 — PASS (spec 5.0–7.5)

• Lead (Pb, ICP-MS): < 0.2 ppm — PASS (spec ≤ 1.0 ppm)

• Arsenic (As): < 0.02 ppm — PASS (spec ≤ 0.5 ppm)

• Cadmium (Cd): < 0.01 ppm — PASS (spec ≤ 0.1 ppm)

• Total Plate Count: 120 cfu/g — PASS (spec ≤ 1,000 cfu/g)

• Salmonella: Absent /25 g — PASS

• Particle size (D90): 180 µm — PASS

• Conclusion: Meets Food Grade specification for dietary use (CoA signed & dated).

10. Typical Applications & Recommended Use Levels

• Dietary supplements: Tablets, capsules, chewables, effervescents — typical supplement dosage is determined by elemental Ca target (e.g., to supply 300–600 mg elemental Ca per dose, calculate CCM mass based on %Ca).

• Food fortification: Beverages (acidic/fortified juices), powdered mixes, nutritional bars — sensory testing recommended as CCM may alter pH/taste.

• Infant / Medical nutrition: Requires pharma-grade material and regulatory approval.

• Industrial: pH buffering, calcium source in non-food applications.

Example calculation: If CCM contains 22.6% elemental Ca, to deliver 500 mg elemental Ca: required CCM ≈ 500 / 0.226 ≈ 2,212 mg (2.21 g).

11. Stability & Compatibility

• Stability: Stable under cool, dry conditions. Moisture uptake over time may reduce flowability and change apparent density.

• Compatibility: Compatible with many food matrices; but in highly alkaline systems CCM may hydrolyze or precipitate; in strongly acidic matrices it is more soluble. Interactions with chelating agents, oxidizers, or ingredients affecting pH should be evaluated in final formulation.

12. Customs / Transport (brief)

• UN classification: Generally not classified as hazardous for transport in typical commercial quantities; check SDS for exported shipments.

• Transport: Pack to prevent moisture ingress and shifting in transit; for bulk transport use FIBCs secured against moisture.

13. Quality & Certification Options (available on request)

• Certificate of Analysis (CoA) for each lot

• Certificate of Origin (COO)

• Microbial test report

• Heavy metals test report (ICP)

• Allergen statement / HACCP declaration

• GMP / ISO / Kosher / Halal certificates (if requested and issued by supplier)

• Stability data (upon contract)