Product Overview
Pharmaceutical Grade Citric Acid is manufactured under strict GMP conditions to meet the highest purity standards required for pharmaceutical, nutraceutical, and medical applications.
Pharmacopoeial Compliance
USP, EP, BP, and IP standards
Highest Purity
99.5-100.0% assay purity
GMP Manufacturing
Strict quality control processes
Full Traceability
Batch-to-batch documentation
Technical Specifications
| Physical & Chemical Properties | |
|---|---|
| Chemical Formula | C₆H₈O₇ (Anhydrous) C₆H₈O₇·H₂O (Monohydrate) |
| Appearance | White crystalline powder |
| Odor & Taste | Odorless with strongly acidic taste |
| Melting Point | 153°C (Anhydrous) 100-105°C (Monohydrate) |
| pH (1% solution) | 2.1 - 2.4 |
| Solubility in Water | 59.2 g/100g at 20°C |
| Particle Size | Customizable (Fine to Coarse) |
| Pharmacopoeial Specifications | |
|---|---|
| Identification | Positive test for citrate |
| Assay (Titrimetric) | 99.5% - 100.0% |
| Water Content | Anhydrous: ≤0.5% Monohydrate: 7.5-9.0% |
| Sulphated Ash | ≤ 0.1% |
| Heavy Metals (as Pb) | ≤ 10 ppm |
| Oxalic Acid | ≤ 100 ppm |
| Arsenic (As) | ≤ 1 ppm |
| Readily Carbonizable Substances | Passes test |
| Bacterial Endotoxins | <0.5 IU/mg (if required) |
Pharmaceutical Applications
Tablet Formulations
Used as acidulant and effervescent agent in pharmaceutical tablets, including chewable, effervescent, and coated tablets.
Syrups & Elixirs
pH adjustment and flavor enhancement in oral liquid formulations, cough syrups, and pediatric medications.
Injectable Solutions
pH adjustment in parenteral formulations, IV solutions, and dialysis fluids with strict endotoxin control.
Topical Preparations
In creams, gels, ointments, and topical solutions for pH adjustment and stability enhancement.
Nutraceuticals
In dietary supplements, vitamin tablets, and nutritional powders requiring pharmaceutical-grade ingredients.
Medical Devices
In dialysis solutions, contrast media, and medical device cleaning/processing solutions.
Why Choose Pharmaceutical Grade?
Full Compliance
Meets all global pharmacopoeial standards (USP, EP, BP, IP)
Complete Documentation
Full DMF, COA, MSDS, and batch traceability documentation
GMP Manufacturing
Manufactured in GMP-compliant facilities with rigorous QC
Regulatory Support
Support for regulatory filings and compliance requirements
Quality Advantage
Manufactured specifically for pharmaceutical applications with complete regulatory compliance and documentation support.
Documentation & Compliance
Certificate of Analysis
Detailed COA with all pharmacopoeial test results
Drug Master File
DMF support for regulatory submissions
Material Safety Data Sheet
Complete safety and handling information
GMP Certificate
Manufacturing facility GMP compliance certificate
Pharmaceutical Packaging
25 kg
Double-lined pharma-grade bags
GMP Packaging10 kg
Sealed HDPE containers
Clean Room Packing5 kg
Pharma-grade aluminum pouches
Sample SizeCustom
Tailored pharma packaging
Validated PackagingOrder Information
Minimum Order
50 kg (pharma batches)
Lead Time
7-14 days (GMP production)
Quality Release
QA release after full testing
Regulatory Support
Documentation for regulatory filings
Pharma Grade vs Industrial Grade
| Parameter | Pharmaceutical Grade | Industrial/Food Grade |
|---|---|---|
| Purity Standard | USP/EP/BP/IP compliant | FCC/E numbers compliant |
| Manufacturing | GMP facilities | Standard manufacturing |
| Documentation | Full DMF, COA, traceability | Basic COA |
| Testing | Full pharmacopoeial tests | Essential parameters only |
| Endotoxin Control | <0.5 IU/mg (if required) | Not specified |
| Applications | Pharmaceutical, medical, injectable | Food, beverage, industrial |
| Packaging | Validated pharma packaging | Standard industrial packaging |
Selection Guide
Choose PHARMACEUTICAL GRADE when:
- For pharmaceutical formulations
- Regulatory filing required
- Injectable or parenteral use
- Medical device applications
- Strict quality documentation needed
- GMP compliance required
