E263 · CAS 5743-26-0

Calcium Acetate Monohydrate

Calcium Acetate Monohydrate is the hydrated calcium salt of acetic acid, with the formula Ca(CH₃COO)₂·H₂O (CAS 5743-26-0). It is best known as the active pharmaceutical ingredient in oral phosphate-binder therapy for patients with chronic kidney disease (CKD) on dialysis.

When taken with meals, the calcium ion binds dietary phosphate in the gut to form insoluble calcium phosphate, which is then eliminated in stool. The result is lower serum phosphate, a key clinical goal in advanced CKD management.

We source bulk Calcium Acetate Monohydrate from top China manufacturers for our partners, working with several of them. The manufacturers are in Shandong and Jiangsu. A smaller requirement can ship in a combined container with other ingredients.

Please send the grade you need, the volume and your destination port, and we will come back with a solution and a price.

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Calcium Acetate Monohydrate
Packaging
25 kg kraft paper bag with PE inner liner
  • ISO 9001
  • HACCP
  • Halal
  • Kosher

Specifications

ItemSpecification
AppearanceWhite crystalline powder or granules
Assay (dry basis)99.0% to 100.5%
Water content10.0% to 13.0%
Free acetic acid≤ 0.5%
Chloride≤ 50 mg/kg
Heavy metals (as Pb)≤ 10 mg/kg
Arsenic≤ 3 mg/kg
Fluoride≤ 50 mg/kg
pH (10% solution)7.0 to 9.0

Common Markets Grades

Calcium Acetate Monohydrate is dominated by two grade tiers.

USP, Ph. Eur., and JP pharmaceutical-grade material is the largest segment, used for the manufacture of oral phosphate binder tablets, capsules, and chewable formulations. Particle-size, bulk-density, and flow-property variants are tailored to direct compression, wet granulation, or capsule-filling lines.

Food Chemicals Codex grade is produced for use as an acidity regulator, sequestrant, and firming agent in food applications. It is also used as a calcium-source ingredient in selected baked-goods and confectionery formulations.

Technical-grade Calcium Acetate is produced for textile dyeing, leather tanning, and as a precursor in laboratory synthesis of acetone by the historic dry-distillation route.

Applications

  • Oral phosphate binder in dialysis patients with chronic kidney disease and hyperphosphatemia
  • Pharmaceutical tablets and capsules for renal nutrition therapy
  • Calcium source for chewable and softgel renal supplements
  • Food acidity regulator, sequestrant, and firming agent in selected baked goods
  • Preservative and antimold agent in bread and tortilla formulations
  • Calcium fortificant in specialty bakery and confectionery
  • Topical otic preparations for the treatment of external ear infections
  • Component of buffering systems in pharmaceutical injectables and dialysate
  • Precursor in the laboratory preparation of acetone by thermal decarboxylation
  • Mordant in textile dyeing and pigment lake formation
  • Component of solid fuels and gel candles when combined with ethanol

How We Help Source Calcium Acetate Monohydrate

  • Direct Factory Sourcing

    We run the whole process: selecting the manufacturer from the top Chinese food ingredient producers, negotiating the price, verifying quality, and coordinating the logistics. You deal with us instead of with several factories at once.

  • Original Packaging and Documents from the Manufacturer

    The manufacturer sends your Calcium Acetate Monohydrate out of its own factory in the original packing, through to your destination port. The COA, COO, MSDS, TDS and any certifications reach you from the manufacturer as well.

  • Free Samples and Lead Time

    We send 100 to 500 g free for your own laboratory to test and you cover only the courier, usually within 2 to 3 working days. ETD is usually within 7 to 15 days once the order is confirmed, and we check that date against the factory's own manufacturing schedule before we give it to you.

  • Combined Shipment

    We can load Calcium Acetate Monohydrate together with other ingredients such as Sodium Acetate, Calcium Citrate and Sodium Lactate into one 20' FCL. If your quantity is small, we can also ship LCL.

Regulatory Status

Calcium Acetate Monohydrate is approved as both a pharmaceutical active and a food ingredient.

The U.S. Food and Drug Administration cleared Calcium Acetate as a phosphate binder for end-stage renal disease in 1990 under the brand name PhosLo, and the product is widely available as generic capsules and tablets. It is included on national formularies and reimbursement schedules for dialysis care.

In food use, the European Union lists Calcium Acetate as additive E263, permitted as an acidity regulator, preservative, and firming agent. The U.S. FDA affirms it as GRAS under 21 CFR 184.1185 for general food use.

Pharmacopoeial monographs appear in USP-NF, Ph. Eur., BP, and JP, with separate monographs for Calcium Acetate Tablets and Capsules. The World Health Organisation includes it in clinical guidelines for the management of mineral and bone disorders in CKD.

Manufacturing Process

Calcium Acetate Monohydrate is manufactured by neutralisation of acetic acid with a calcium source.

Glacial acetic acid is reacted with calcium carbonate or calcium hydroxide in aqueous solution under controlled temperature. CO₂ is liberated when the carbonate route is used and is captured for reuse. The resulting Calcium Acetate solution is concentrated and cooled to crystallise the monohydrate.

The crystals are recovered by centrifugation, washed with deionized water, and dried at moderate temperature to preserve the hydrate. Overdrying converts the material to the anhydrous form, which is hygroscopic and undesirable for most pharmaceutical applications.

Pharmaceutical-grade material undergoes activated-carbon polishing of the crystallisation mother liquor, recrystallisation, and final milling to a controlled particle size suitable for tablet compression. Heavy-metals and microbial limits are tested to USP, Ph. Eur., and JP specifications.