High Purity Calcium Acetate Monohydrate FCC/USP Standard

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Product Details
Customization: Available
CAS No.: 5743-26-0
Formula: C4h6cao4
Manufacturer/Factory & Trading Company
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Basic Info.

Model NO.
/
EINECS
611-528-1
Composition
Calcium Propionate
Type
Bread Preservative
Effect
Antiseptic
Resource
Inorganic Chemical Preservatives
Transport Package
25kg
Specification
25kg
Trademark
Flying Deer
Origin
China
HS Code
291550
Production Capacity
4000t/Year

Product Description

Hero Banner & Core Value

The Gold Standard in Phosphate Binding: Pharmaceutical Grade Calcium Acetate

Phosphate Binder | USP/EP Compliant | Hyperphosphatemia Management | Ultra-Low Heavy Metals

Secure your pharmaceutical and dietary supplement supply chain with uncompromising quality. Our Pharmaceutical Grade Calcium Acetate Powder (CAS 62-54-4) is an advanced, high-purity active ingredient and premium calcium source. Engineered specifically for the management of hyperphosphatemia in Chronic Kidney Disease (CKD) patients, it offers superior phosphate-binding capacity in the gastrointestinal tract compared to traditional calcium carbonate, ensuring safe and highly effective clinical outcomes.

High Purity Calcium Acetate Monohydrate FCC/USP Standard

Technical Specifications & Pharmacopeia Standards

Product Name: Calcium Acetate Anhydrous / Monohydrate

CAS No.: 62-54-4 (Anhydrous) / 5743-26-0 (Monohydrate)

Grade: Pharmaceutical Grade / High-End Nutraceutical (USP / EP Standards)

Parameter Clinical / Pharma Specification Relevance for Medical Formulation
Assay (Purity) 99.0% - 100.5% (Dry basis) Ensures precise and predictable dosing in tablets/capsules.
Heavy Metals (as Pb) ≤ 2 ppm Crucial for patients with compromised renal function.
Arsenic (As) ≤ 1 ppm Strictly meets global pharmacopeia safety limits.
Fluoride ≤ 0.005% Prevents bone toxicity during long-term administration.
Water Insolubles ≤ 0.1% Clear dissolution; essential for liquid oral suspensions.
pH (1 in 20 Solution) 6.3 - 9.6 Optimal for gastrointestinal tolerability.
 

 Core Advantages (The Clinical Edge)

  • Superior Binding Efficiency: Calcium acetate binds approximately twice as much dietary phosphorus per milligram of elemental calcium compared to calcium carbonate, requiring a lower total calcium load for the patient.

  • Gastric Acid Independence: Unlike calcium carbonate, which requires an acidic stomach environment to dissolve, calcium acetate is highly soluble across a wide pH range, making it effective even in patients taking proton pump inhibitors (PPIs).

  • Aluminum-Free & Magnesium-Free: Eliminates the risk of aluminum toxicity and magnesium accumulation in patients with severe renal impairment.

  • Excellent Compressibility: Formulated with an optimized particle size distribution, ensuring smooth flowability and high tablet hardness for high-speed rotary press machines.

 

Mechanism of Action - Gastrointestinal Binding

  • The Chemical Chelation: When administered orally with meals, Calcium Acetate rapidly dissolves in the stomach and small intestine. The active $Ca^{2+}$ ions chemically react with dietary phosphate groups ($PO_4^{3-}$).

  • Insoluble Excretion: This reaction forms insoluble calcium phosphate complexes ($Ca_3(PO_4)_2$) within the gastrointestinal lumen. Because these complexes cannot be absorbed into the bloodstream, they are safely excreted in the feces, effectively lowering serum phosphorus levels.

 

Application & Formulation Guide

Optimized for CMOs, CDMOs, and dietary supplement manufacturers:

  • Gelatin/HPMC Capsules: Used as the primary Active Pharmaceutical Ingredient (API) for 667 mg dosage forms.

  • Coated Tablets: Excellent compatibility with standard binders (like PVP or HPMC) and disintegrants for film-coated tablet production.

  • Oral Liquid Suspensions: Ultra-low water insolubles make it ideal for pediatric or geriatric liquid phosphate binder formulations.

  • Advanced Dialysis Nutrition: Blended into specialized medical foods and meal replacement powders designed for renal care patients.

 

Quality, Safety & Global Compliance

  • GMP Manufacturing: Produced in a cleanroom environment adhering to Good Manufacturing Practices (GMP) and ISO 9001/22000 quality systems.

  • Pharmacopeia Compliance: Every batch is tested against and fully complies with the latest United States Pharmacopeia (USP) and European Pharmacopoeia (EP) monographs.

  • Documentation: Comprehensive COA, MSDS, and Method of Analysis (MOA) available for your regulatory department's strict QA/QC audits.

 

Packaging & Global Logistics

  • Standard Packing: 25kg pharmaceutical-grade fiber drums with double-layered, anti-static PE inner bags to guarantee zero contamination.

  • Optimized Loading Capacity (20' FCL):

    • Palletized (Strict Pharma Requirement): 14 MT - 16 MT (Depending on drum dimensions). For pharmaceutical grades, palletization and shrink-wrapping are mandatory to prevent transit damage and ensure cleanroom-ready unloading.

  • Storage: Hygroscopic in nature. Must be kept tightly sealed in a highly controlled, dry environment.

 

The Pharma & Supplement Consolidation Hub (Mixed FCL)

Streamline Your Medical Supply Chain with Hangzhou Union Biotechnology.

Pharmaceutical and high-end supplement manufacturers demand a secure, consolidated supply chain. Leverage our Mixed FCL Service to bundle your Calcium Acetate with other clinical-grade ingredients:

  • Renal Nutrition Support: Taurine (Supports cardiovascular health in renal patients) and Creatine Monohydrate (Muscle mass preservation).

  • Immune & Antioxidant Systems: Ascorbic Acid (Vitamin C).

  • Formulation Excipients: Trehalose (For stabilizing active biologicals in your production line).

 

Strategic FAQ for Formulation Scientists & Purchasing Directors

Q: Why should our procurement switch from Calcium Carbonate to Calcium Acetate for CKD supplements?

A: Clinical efficiency. Calcium Acetate provides better phosphate binding with less elemental calcium absorption. This significantly lowers the risk of severe hypercalcemia (vascular calcification) in CKD patients compared to heavy calcium carbonate dosing.

Q: Can you provide customized particle sizes for direct compression tableting?

A: Yes. Depending on your manufacturing equipment, we can supply fine powders for wet granulation or specifically milled granular variants optimized for direct compression. Please specify your mesh size requirements in your inquiry.

Q: Is this product suitable for purely nutritional (bone health) supplements?

A: Absolutely. While its premium purity makes it the standard for CKD phosphate binding, its extremely high solubility also makes it a highly bioavailable calcium source for premium bone-density dietary supplements, far surpassing standard calcium citrate or carbonate.

High Purity Calcium Acetate Monohydrate FCC/USP StandardHigh Purity Calcium Acetate Monohydrate FCC/USP Standard

 



Company Profile: 

1. Main product:  Food ingredients & additives
2. Location: Office in Hangzhou, China;  Preservative & Flavoring agents factories in Shandong and Shanghai.
3. Main market: Middle East, Middle Asia, South-east Asia, Africa
4. Certificate: ISO, KOSHER, HALAL, SGS and more
    Employees: 51-100
    R&D staffs: 5-10
    Factory Size: 5,000-10,000 square meters
 
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High Purity Calcium Acetate Monohydrate FCC/USP Standard
High Purity Calcium Acetate Monohydrate FCC/USP Standard
High Purity Calcium Acetate Monohydrate FCC/USP Standard

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