Product Overview & China Production Capacity
Citric Acid (CAS 77-92-9, molecular formula C₆H₈O₇, MW 192.12) is the most widely used organic acid in pharmaceutical manufacturing, serving as a buffering agent, pH adjuster, chelating agent, effervescent component, and antioxidant synergist. It is essential in effervescent tablet formulations (paired with bicarbonate), oral liquid preparations for pH control and taste enhancement, and parenteral solutions as a metal ion chelator. It also acts as a plasticizer modifier in film coating systems.
China is the world’s dominant citric acid producer, accounting for over 70% of global output with annual production exceeding 2 million MT. Our fermentation facility in Anhui Province produces 120,000 MT/year of citric acid through submerged fermentation of corn starch using Aspergillus niger, with dedicated pharmaceutical-grade processing lines achieving ultra-high purity.
Manufacturing Standards & Quality Assurance
Our production holds FSSC 22000, ISO 9001:2015, and HACCP certifications. The product complies with USP/NF, EP, BP, JP, and ChP monograph requirements. We also meet FCC (Food Chemicals Codex) and JECFA specifications. The fermentation-to-crystallization process uses non-GMO corn substrates, and we hold Non-GMO Project verification, Halal, and Kosher certifications.
Quality control encompasses assay by titration, water content (Karl Fischer), sulfate, oxalate, calcium, heavy metals, readily carbonizable substances, bacterial endotoxin (for injection-grade), and complete microbiological testing. We produce anhydrous and monohydrate forms, each with full pharmacopeial compliance documentation.
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or granules |
| Assay | 99.5–100.5% |
| Water (Karl Fischer) | ≤0.5% |
| Sulfate (SO₄) | ≤150 ppm |
| Oxalate | ≤350 ppm |
| Calcium (Ca) | ≤200 ppm |
| Heavy Metals (as Pb) | ≤10 ppm |
| Lead (Pb) | ≤0.5 ppm |
| Readily Carbonizable Substances | Passes USP test |
| Bacterial Endotoxins | ≤0.5 EU/mg (parenteral grade) |
Packaging & Export Logistics
Available in 25 kg PE-lined kraft bags, 1,000 kg FIBCs, and custom packaging. Multiple particle sizes are offered: fine powder, regular granular, and coarse granular for effervescent applications. Store in dry conditions at 15–25°C. Shelf life is 36 months. Non-hazardous for transport. Container loading: approximately 25 MT per 20′ FCL.
We ship from Shanghai, Qingdao, and Lianyungang ports with regular container service to all global destinations. Full documentation package includes COA, MSDS, Non-GMO certification, Halal/Kosher certificates, and FDA registration confirmation.
China Supply Advantage
As the world’s citric acid production center, China offers unmatched pricing — typically 50–65% below European and North American producers for equivalent pharmaceutical-grade quality. Our scale of production, efficient corn-based fermentation process, and optimized energy usage deliver the lowest global production costs with no quality compromise.
MOQ is 1,000 kg with 5–7 business day lead times for stock grades. We maintain 5,000+ MT ready stock year-round. Volume pricing is available for annual contracts exceeding 50 MT. We can supply both anhydrous and monohydrate forms, as well as parenteral-grade citric acid with endotoxin certification. Contact us for a competitive quotation.