Pharmaceutical Grade Citric Acid Monohydrate

Name: Pharmaceutical Grade Citric Acid Monohydrate
Brand: Lanyao Water Treatment Co.,Ltd.
Rating: 4.2 (42 reviews)

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Pharmaceutical Grade Citric Acid Monohydrate

Pharmaceutical Grade Citric Acid Monohydrate (chemical formula C?H?O?·H?O, CAS No. 5949-29-1) is a high-purity pharmaceutical-grade organic acid that complies with authoritative international pharmacopoeial standards including USP, EP, BP, JP and ChP.

It appears as colorless transparent crystals or white crystalline powder with a refreshing sour taste, freely soluble in water, and its aqueous solution is acidic. It is an indispensable key pharmaceutical excipient and functional ingredient in the pharmaceutical industry.

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Core Properties

Pharmaceutical Grade Citric Acid Monohydrate features outstanding purity and multifunctionality:

Ultra-high purity: Assay (on anhydrous basis) 99.5%–100.5%, moisture strictly controlled at 7.5%–8.8%, with extremely low impurities: oxalates <100 mg/kg, sulfates <100 mg/kg, heavy metals <5 mg/kg, arsenic <1 mg/kg, lead <0.5 mg/kg, ensuring drug safety and batch-to-batch consistency.
Excellent solubility: Very highly soluble in water (solubility approx. 1630 g/L at 20°C), forming clear solutions; pH (1% solution) approx. 2.0–2.4, providing a precise acidic environment for pharmaceutical formulations.
Chemical stability: Stable at room temperature; begins to lose water of crystallization at 78°C, melting/decomposition point 135–152°C, meeting requirements for conventional pharmaceutical processes.
Excellent biocompatibility: As a natural intermediate of the human tricarboxylic acid cycle (TCA cycle), it is non-toxic, harmless, fully metabolizable and absorbable by the human body, with extremely high safety.
Multifunctionality: Acts as pH regulator, buffer, antioxidant synergist, chelating agent, flavoring agent, and anticoagulant, playing multiple critical roles in drug formulations.

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Quality Specifications (Compliant with USP / EP / BP Standards)

Pharmaceutical Grade Citric Acid Monohydrate is manufactured in accordance with the world’s strictest pharmacopoeial standards. Typical specifications:

Assay (on anhydrous basis): 99.5%–100.5%
Moisture: 7.5%–8.8%
Clarity of solution: Complies with requirements
Color: Colorless
Readily carbonizable substances: Complies with pharmacopoeial requirements
Oxalates: ≤100 mg/kg
Sulfates: ≤100 mg/kg
Chlorides: ≤5 mg/kg
Calcium: ≤30 mg/kg
Iron: ≤3 mg/kg
Heavy metals (as Pb): ≤5 mg/kg
Arsenic: ≤1 mg/kg
Mercury: ≤0.5 mg/kg
Lead: ≤0.5 mg/kg
Residue on ignition: ≤0.05%

The product is produced in GMP-certified facilities to avoid cross-contamination. Complete regulatory documents are available, including DMF, CoA and MSDS.

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Main Classifications

Pharmaceutical Grade Citric Acid Monohydrate is divided into three grades by application and specification:

Oral Formulation Grade
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Colorless crystals or white powder with moderate particle size and fast dissolution.
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Used in oral liquids, syrups, effervescent tablets, chewable tablets, granules, etc., as pH regulator, buffer and flavoring agent.

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Injection Grade
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Ultra-high-purity crystals with strict limits on endotoxins and pyrogens.
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Used in sterile preparations such as injections, infusions and eye drops, as pH regulator and anticoagulant, with extremely high safety requirements.

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Biopharmaceutical Grade
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Specially refined product with low endotoxin and low metal ion content.
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Used in high-end pharmaceutical fields including biologics, vaccines, cell culture and blood products, providing stable acidic environment and chelation protection.

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Applications

pH Regulator and Buffer (Core Application)

In oral liquids, injections, eye drops and other pharmaceutical formulations, it accurately adjusts pH to the range of 2.5–5.0, ensuring stability and solubility of active pharmaceutical ingredients, improving bioavailability, enhancing preservative efficacy and reducing preservative dosage.

Its strong buffering capacity effectively resists external pH changes and guarantees stable quality during storage.

Effervescent and Immediate-Release Preparations

Pharmaceutical Grade Citric Acid Monohydrate forms a classic effervescent system with sodium bicarbonate or sodium carbonate, reacting rapidly in water to generate large amounts of carbon dioxide, enabling fast disintegration and dissolution of drugs and improving patient compliance.

Widely used in antipyretic analgesics, vitamin supplements, electrolyte supplements, antacids, etc.

Anticoagulation and Blood Preservation

Sodium citrate (produced by reacting citric acid with sodium hydroxide) is the most critical in vitro anticoagulant for blood collection, storage and transfusion. It chelates calcium ions in blood to inhibit the coagulation cascade and prevent clotting, ensuring the safety of blood samples and transfusion products.

ACD-A (Anticoagulant Citrate Dextrose Solution A) is a standard reagent for blood separation and endothelial progenitor cell extraction.

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