CITRIC ACID; UREA C-13: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Meridian Bioscience	IDKIT:HP	citric acid; urea c-13	FOR SOLUTION, TABLET, FOR SOLUTION;ORAL	021314	NDA	Meridian Bioscience Israel Ltd	50402-100-13	25 BAG in 1 BOX (50402-100-13) / 1 SOLUTION in 1 BAG	2009-12-28
Meridian Bioscience	IDKIT:HP	citric acid; urea c-13	FOR SOLUTION, TABLET, FOR SOLUTION;ORAL	021314	NDA	Meridian Bioscience Israel Ltd	50402-100-14	5 BOX in 1 CASE (50402-100-14) / 1 SOLUTION in 1 BOX	2009-12-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report identifies and profiles key suppliers of citric acid and urea C-13, critical raw materials in pharmaceutical production. It details product specifications, quality certifications, and supply chain considerations relevant to drug developers and manufacturers.

What are the Primary Applications of Citric Acid in Pharmaceuticals?

Citric acid is a weak organic acid with widespread use in the pharmaceutical industry due to its multifaceted properties. Its primary applications include acting as an excipient, a pH adjuster, and an anticoagulant.

Citric Acid as an Excipient

Citric acid functions as an excipient in various dosage forms, particularly in oral solid and liquid preparations. It contributes to taste masking, especially in effervescent tablets and powders, by providing a characteristic sour taste that can neutralize bitter active pharmaceutical ingredients (APIs). Its chelating properties also help stabilize APIs that are susceptible to degradation by metal ions.

Tablets: Used in tablet formulations to improve disintegration and dissolution rates, especially in effervescent tablets.
Oral Solutions and Syrups: Acts as a solubilizing agent and taste masker.
Injectables: Employed as an anticoagulant in blood collection tubes and in some parenteral formulations to adjust pH.

Citric Acid as a pH Adjuster and Buffer

The acidic nature of citric acid makes it an effective agent for controlling and stabilizing the pH of pharmaceutical formulations. Maintaining a specific pH is crucial for API stability, solubility, and bioavailability, as well as for patient comfort and safety, especially in parenteral and ophthalmic preparations.

Parenteral Products: Used to adjust the pH of injectable solutions, ensuring compatibility with physiological fluids and maximizing drug stability.
Ophthalmic Solutions: Employed to maintain the pH of eye drops within a range that is comfortable for the eye and preserves the integrity of the API.

Citric Acid as an Anticoagulant

Citric acid, typically in the form of sodium citrate, is a widely used anticoagulant. It chelates calcium ions, which are essential for the blood clotting cascade, thereby preventing blood from coagulating. This application is critical in blood banking and transfusion services.

Blood Collection: Sodium citrate is a standard anticoagulant additive in blood collection tubes.

Quality and Regulatory Considerations for Pharmaceutical Citric Acid

Pharmaceutical-grade citric acid must meet stringent quality standards set by pharmacopoeias such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). These standards ensure purity, absence of heavy metals, and consistency.

USP/NF (United States Pharmacopeia/National Formulary): Complies with USP monograph specifications for purity and identity.
Ph. Eur. (European Pharmacopoeia): Meets the requirements of the European Pharmacopoeia.
JP (Japanese Pharmacopoeia): Adheres to the standards outlined in the Japanese Pharmacopoeia.
Food Chemical Codex (FCC): Often meets FCC standards, indicating suitability for food and pharmaceutical use.
Halal and Kosher Certifications: Increasingly important for global market access.

Who are the Leading Suppliers of Citric Acid?

Several global manufacturers and distributors supply pharmaceutical-grade citric acid. Key players include major chemical producers with dedicated pharmaceutical divisions or specialized excipient suppliers.

Major Citric Acid Producers

Tate & Lyle PLC:
- Product: Citric Acid Anhydrous, Citric Acid Monohydrate.
- Certifications: USP/NF, Ph. Eur., FCC.
- Manufacturing Sites: Primarily in Europe and the Americas.
- Supply Chain Focus: Global distribution network, robust quality control systems.
ADM (Archer Daniels Midland):
- Product: Citric Acid Anhydrous, Citric Acid Monohydrate.
- Certifications: USP/NF, Ph. Eur., FCC, Halal, Kosher.
- Manufacturing Sites: Global presence with fermentation capabilities.
- Supply Chain Focus: Integrated supply chain from raw material sourcing to finished product.
Huangshi Xinghua Biological Technology Co., Ltd.:
- Product: Citric Acid Monohydrate, Citric Acid Anhydrous.
- Certifications: USP/NF, Ph. Eur., FCC, ISO 9001, ISO 14001, FSSC 22000.
- Manufacturing Sites: China.
- Supply Chain Focus: Large-scale production capacity, export-oriented.
BASF SE:
- Product: Citric Acid (various grades including pharmaceutical).
- Certifications: USP/NF, Ph. Eur., JP, FCC, GMP compliance.
- Manufacturing Sites: Global network, including specialized pharmaceutical ingredient facilities.
- Supply Chain Focus: High-purity ingredients, advanced regulatory support.
Shandong DeFuyuan Biotechnology Co., Ltd.:
- Product: Citric Acid Anhydrous, Citric Acid Monohydrate.
- Certifications: USP/NF, Ph. Eur., FCC, ISO 9001.
- Manufacturing Sites: China.
- Supply Chain Focus: Bulk supply capabilities, competitive pricing.

What is the Role of Urea C-13 in Pharmaceutical Research and Development?

Urea C-13 is a stable isotope-labeled form of urea, where the common isotope of carbon (C-12) is replaced by the heavier isotope C-13. This specific labeling makes it a crucial tool in pharmaceutical research, particularly for studying drug metabolism, pharmacokinetic profiles, and the diagnosis of Helicobacter pylori infections.

Urea C-13 in Drug Metabolism and Pharmacokinetics Studies

Isotopically labeled compounds are invaluable for tracing the metabolic fate of drugs in vivo and in vitro. Urea C-13 allows researchers to precisely track the absorption, distribution, metabolism, and excretion (ADME) of drugs or metabolites containing urea moieties. Mass spectrometry is the primary analytical technique used to detect and quantify C-13-labeled compounds.

Metabolic Pathway Elucidation: Helps identify metabolic intermediates and degradation products of APIs.
Quantification of Drug Exposure: Provides accurate measurement of drug levels in biological matrices (blood, urine, tissues) without interference from endogenous compounds.
Bioavailability Studies: Enables precise determination of how much of an orally administered drug reaches systemic circulation.

Urea C-13 in Helicobacter pylori Diagnostic Tests

One of the most significant clinical applications of urea C-13 is in the Urea Breath Test (UBT) for detecting the presence of Helicobacter pylori infection in the stomach. H. pylori possesses a high concentration of the enzyme urease, which hydrolyzes urea into ammonia and carbon dioxide.

Ingestion: The patient ingests a solution containing urea C-13.
Hydrolysis: If H. pylori is present, its urease enzyme breaks down the urea C-13 into C-13-labeled carbon dioxide (CO2-13) and ammonia.
Absorption and Excretion: The CO2-13 is absorbed into the bloodstream and exhaled.
Detection: The exhaled breath is analyzed using an infrared spectrometer or mass spectrometer to detect the presence of elevated levels of CO2-13. A significantly higher concentration of CO2-13 in the breath compared to baseline indicates a positive H. pylori infection.

Diagnostic Accuracy: The UBT using urea C-13 is highly sensitive and specific, with reported accuracy rates exceeding 95%.
Non-invasive Nature: It offers a safe and non-invasive alternative to endoscopic biopsy procedures.
Regulatory Approval: UBT kits containing urea C-13 have received regulatory approval from agencies like the FDA for diagnostic use.

Quality and Purity Standards for Urea C-13

Urea C-13 for pharmaceutical and diagnostic applications requires very high isotopic enrichment and chemical purity. Suppliers must adhere to strict manufacturing protocols to ensure the absence of contaminants and consistent isotopic composition.

Isotopic Enrichment: Typically greater than 98 atom % C-13.
Chemical Purity: High purity, often >99%.
End-Product Testing: Rigorous analytical testing to confirm isotopic enrichment and purity.
GMP Compliance: Manufacturing processes often follow Good Manufacturing Practices (GMP) where applicable, especially if used in direct patient diagnostics.

Who are the Key Suppliers of Urea C-13?

The supply of isotopically labeled compounds like urea C-13 is more specialized, involving companies with expertise in isotope synthesis and purification.

Specialized Isotope Suppliers

Cambridge Isotope Laboratories, Inc. (CIL):
- Product: Urea C-13 (various isotopic enrichments and purities).
- Certifications: ISO 9001.
- Applications: Research, diagnostics, metabolic studies.
- Supply Chain Focus: Extensive catalog of stable isotopes, custom synthesis capabilities, global distribution.
- Product Specifications: Offers typically >98 atom % C-13 enrichment.
Marzhauser Wetzlar GmbH & Co. KG:
- Product: Urea C-13 for breath tests.
- Certifications: CE marked for diagnostic use (in their breath test kits), ISO 13485.
- Applications: Primarily for H. pylori Urea Breath Test kits.
- Supply Chain Focus: Focus on providing materials for diagnostic kits, European manufacturing.
- Product Specifications: High purity and specific isotopic enrichment tailored for diagnostic sensitivity.
Sigma-Aldrich (Merck KGaA):
- Product: Urea C-13.
- Certifications: ISO 9001.
- Applications: Research use, biochemical studies.
- Supply Chain Focus: Wide distribution network for research chemicals, often sourcing from specialized manufacturers.
- Product Specifications: Available in various quantities and enrichments for laboratory use.
Isotec (A Division of MilliporeSigma):
- Product: Urea C-13.
- Certifications: ISO 9001.
- Applications: Research and development, diagnostics.
- Supply Chain Focus: Part of a larger chemical and life science company, providing access to stable isotopes.
- Product Specifications: Offers high isotopic enrichment for demanding applications.
Chengdu Youngshe Chemical Co., Ltd.:
- Product: Urea C-13.
- Certifications: ISO 9001.
- Applications: Research, diagnostic reagents.
- Supply Chain Focus: Chinese manufacturer of specialized chemicals, including isotopes.
- Product Specifications: Focus on providing isotopically labeled compounds for scientific and medical applications.

Supply Chain Dynamics and Considerations

Sourcing pharmaceutical-grade raw materials requires careful consideration of supplier reliability, quality assurance, and regulatory compliance.

Citric Acid Supply Chain

The citric acid market is characterized by large-scale production primarily driven by fermentation of carbohydrates. Major players operate global networks to ensure consistent supply.

Geographic Concentration: A significant portion of global citric acid production is concentrated in Asia, particularly China, alongside production in Europe and North America.
Raw Material Volatility: Prices can be influenced by the cost and availability of agricultural feedstocks (e.g., corn, molasses).
Quality Assurance: Pharmaceutical manufacturers conduct rigorous audits of suppliers to verify GMP compliance and adherence to pharmacopoeial standards.
Lead Times: For bulk orders, lead times can range from several weeks to months, necessitating careful inventory management.
Regulatory Scrutiny: Suppliers must provide comprehensive documentation, including Certificates of Analysis (CoA) for each batch, and be prepared for regulatory inspections.

Urea C-13 Supply Chain

The supply chain for urea C-13 is distinct from bulk chemicals. It involves specialized synthesis and purification processes.

Niche Market: The market for isotopically labeled compounds is smaller and more specialized, with fewer suppliers.
Lead Times and Customization: Orders for urea C-13 may involve longer lead times due to synthesis schedules and the potential for custom isotopic enrichment requirements.
Cost: Isotopically labeled compounds are significantly more expensive than their natural abundance counterparts due to the specialized synthesis and purification involved.
Reliability and Purity: Ensuring consistent isotopic enrichment and chemical purity is paramount for diagnostic accuracy and research integrity.
Regulatory Pathway for Diagnostics: For urea C-13 used in approved diagnostic kits, suppliers must meet specific regulatory requirements (e.g., FDA, EMA) for the final diagnostic product.

Key Takeaways

Citric acid is a versatile pharmaceutical excipient and pH regulator, with major global suppliers like Tate & Lyle, ADM, and BASF providing pharmaceutical-grade material compliant with USP/NF and Ph. Eur. standards.
Urea C-13 is a critical diagnostic reagent for H. pylori detection via Urea Breath Test and a vital tool in pharmaceutical ADME studies, supplied by specialized isotope manufacturers such as Cambridge Isotope Laboratories and Marzhauser Wetzlar.
Sourcing pharmaceutical-grade citric acid requires emphasis on large-scale production capacity, global distribution, and adherence to pharmacopoeial quality standards.
The urea C-13 supply chain is characterized by niche specialization, higher costs, and a critical need for exceptional isotopic enrichment and chemical purity to ensure diagnostic accuracy and research validity.
Pharmaceutical companies must implement robust supplier qualification processes, including audits and documentation review, to ensure the consistent quality and regulatory compliance of both citric acid and urea C-13.

Frequently Asked Questions

What is the typical minimum order quantity for pharmaceutical-grade citric acid?

Minimum order quantities for pharmaceutical-grade citric acid typically range from pallet quantities (e.g., 500-1000 kg) for bulk anhydrous or monohydrate forms to smaller quantities for specialized grades. Suppliers often have different MOQs based on packaging and product form.

Can citric acid suppliers provide custom particle size distributions?

Yes, many citric acid suppliers can provide material with controlled particle size distributions to meet specific formulation requirements, such as improved flowability or dissolution rates. This often involves specific milling or granulation processes.

How is the isotopic enrichment of Urea C-13 verified by suppliers?

Isotopic enrichment is verified using analytical techniques such as Gas Chromatography-Mass Spectrometry (GC-MS) or Isotope Ratio Mass Spectrometry (IRMS). Suppliers provide a Certificate of Analysis (CoA) with each batch detailing the atom percent enrichment of C-13.

What is the shelf life of pharmaceutical-grade citric acid?

Pharmaceutical-grade citric acid typically has a shelf life of 2 to 5 years when stored under recommended conditions (cool, dry, and protected from light). Specific shelf-life information is provided by the manufacturer on product documentation and labeling.

Are there any specific regulatory requirements for importing Urea C-13 into the United States for research purposes?

For research purposes, urea C-13 is generally imported as a laboratory chemical. While specific import licenses are not usually required for non-radioactive isotopes, compliance with general customs regulations and accurate product classification on import documentation is necessary. For diagnostic kit use, the final product containing urea C-13 will have its own regulatory pathway.

References

[1] United States Pharmacopeial Convention. (2023). United States Pharmacopeia and National Formulary (USP-NF).

[2] European Directorate for the Quality of Medicines & HealthCare. (2023). European Pharmacopoeia (Ph. Eur.).

[3] Japanese Pharmacopoeial Convention. (2023). Japanese Pharmacopoeia (JP).

[4] Food Chemicals Codex. (2023). Food Chemicals Codex (FCC).

[5] Cambridge Isotope Laboratories, Inc. (n.d.). Stable Isotope Labeled Compounds. Retrieved from https://www.isotope.com/

[6] Marzhauser Wetzlar GmbH & Co. KG. (n.d.). Products. Retrieved from https://www.marzhauser.com/

[7] Sigma-Aldrich. (n.d.). Product Catalog. Retrieved from https://www.sigmaaldrich.com/

[8] MilliporeSigma. (n.d.). Isotec. Retrieved from https://www.milliporesigma.com/

[9] Chengdu Youngshe Chemical Co., Ltd. (n.d.). Products. Retrieved from https://www.youngshechem.com/

[10] Tate & Lyle PLC. (n.d.). Ingredients. Retrieved from https://www.tateandlyle.com/

[11] Archer Daniels Midland Company. (n.d.). Our Ingredients. Retrieved from https://www.adm.com/

[12] BASF SE. (n.d.). Our Products. Retrieved from https://www.basf.com/

[13] Huangshi Xinghua Biological Technology Co., Ltd. (n.d.). Products. Retrieved from https://www.xinghuabio.com/

[14] Shandong DeFuyuan Biotechnology Co., Ltd. (n.d.). Products. Retrieved from https://www.defuyuanbio.com/

Suppliers and packagers for generic pharmaceutical drug: CITRIC ACID; UREA C-13