# SODIUM CITRATE (sodium-citrate) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/sodium-citrate
- **Standard INCI**: `SODIUM CITRATE`
- **KR MFDS Standard Name**: `소듐시트레이트`
- **CAS No.**: `994-36-5`
- **EC / EINECS No.**: `200-675-3`
- **Origin**: `synthetic`
- **Functions**: pH조절제, 킬레이트제, 향료, 완충제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 소듐시트레이트 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | SODIUM CITRATE |
| US (PCPC / MoCRA INCI) | SODIUM CITRATE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 柠檬酸钠 |
| JP (JCIA / MHLW QD) | クエン酸Ｎａ (QD: クエン酸ナトリウム) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `4856`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- Listed within general cosmetic GMP safety thresholds.

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4 – 8
- **Max Process Temp**: ≤ 50°C
- **Synergy Pairings**: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL
- **Incompatibilities**: Verify phase compatibility under extreme pH or high electrolyte loads

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: SODIUM CITRATE | CAS No.: 994-36-5 | EC No.: 200-675-3
  - Origin: SYNTHETIC | Functions: pH, , , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [SODIUM CITRATE] · EU [SODIUM CITRATE] · CN [柠檬酸钠] · JP [クエン酸Ｎａ] · JP Quasi-Drug [クエン酸ナトリウム]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - SODIUM CITRATE functions primarily as pH, , ,  in dermatological and cosmetic formulations. Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver pH, , ,  performance and structural formulation stability.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
  - Regional Summary: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 4856 (柠檬酸钠))
  - No specific Annex prohibition or numeric restriction across the 6 major jurisdictions (Permitted under general GMP safety assessment).
  - Official Safety & Historical Use Concentration (Layer 2): Quantum satis (QS) within standard cosmetic safety margins
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [emulsion_cream] Typical range: 0.1 ~ 0.3% (Median 0.15%, Ref: Global Starter Formulation Library Statistical Distribution (n=6, EVONIK 5 · GRANT 1)) — Emulsion cream & lotion structural / conditioning agent
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Water Phase or Cool-down Phase (< 45°C)
  - Optimal pH Range: pH 4.0 ~ 8.0 | Max Process Temp: Max 50°C | Electrolyte Tolerance: MEDIUM
  - Incompatibility / Caution: Verify phase compatibility under extreme pH or high electrolyte loads
  - Synergy Pairings: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | Reference Trade Names: SODIUM CITRATE
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 40961341 (2025, Biomacromolecules): Rapid Template-Transferred Printing of Gelatin-Based Ionogels with Bioinspired Hierarchical Microstructures for Flexible
  - PMID 40808612 (2025, J Biomed Mater Res A): Fish Collagen-Based Bilayer Composite Scaffold Functionalized With Fibrin/Hydroxyapatite/Sodium Citrate for Osteochondra
  - PMID 40167422 (2025, ACS Appl Mater Interfaces): Exudate Management, Facile Detachment, and Immunometabolism Regulation for Wound Healing Using Breathable Dressings

## 6. Linked PubMed Literature
- [PMID: 40961341] Rapid Template-Transferred Printing of Gelatin-Based Ionogels with Bioinspired Hierarchical Microstructures for Flexible Tactile Sensors — *Biomacromolecules* (2025)
- [PMID: 40808612] Fish Collagen-Based Bilayer Composite Scaffold Functionalized With Fibrin/Hydroxyapatite/Sodium Citrate for Osteochondral Tissue Engineering-In Vitro and In Vivo Studies — *J Biomed Mater Res A* (2025)
- [PMID: 40167422] Exudate Management, Facile Detachment, and Immunometabolism Regulation for Wound Healing Using Breathable Dressings — *ACS Appl Mater Interfaces* (2025)
- [PMID: 39997665] Electrospun Collagen-Coated Nanofiber Membranes Functionalized with Silver Nanoparticles for Advanced Wound Healing Applications — *Membranes (Basel)* (2025)
- [PMID: 39769926] Studying the Effect of Reducing Agents on the Properties of Gold Nanoparticles and Their Integration into Hyaluronic Acid Hydrogels — *Molecules* (2024)
- [PMID: 39542291] Construction of high strength PVA/cellulose conductive hydrogels based on sodium citrate/aluminium chloride dual ions regulation — *Int J Biol Macromol* (2024)
- [PMID: 42244882] Original research a real-world study of adverse events of nafamostat mesylate and sodium citrate based on the world health organization-VigiAccess database — *Front Pharmacol* (2026)
- [PMID: 42042185] A Multifunctional Shape-Adaptive Bilayer Hydrogel for Acute Hemostasis, Wound Repair, and Insect Bite Defense — *Gels* (2026)
- [PMID: 41506309] Biodegradable sodium citrate-treated hyaluronic acid microspheres for genicular artery embolization — *Acta Biomater* (2026)
- [PMID: 39771596] Potential of Cricket Chitosan for Nanoparticle Development Through Ionotropic Gelation: Novel Source for Cosmeceutical Delivery Systems — *Pharmaceutics* (2024)
- [PMID: 39598902] Hyperbranched Thermosensitive Polymer-AuNP Composite Probe for Temperature Colorimetric Detection — *Sensors (Basel)* (2024)
- [PMID: 39460395] Paintable, Fast Gelation, Highly Adhesive Hydrogels for High-fidelity Electrophysiological Monitoring Wirelessly — *Small* (2025)