Product Overview

Riboflavin Sodium Phosphate is a water-soluble riboflavin derivative used in nutritional and pharmaceutical formulations.

Technical Specifications

Category	Item	Specification
1. Purity & Composition Control	Assay (Dried Basis)	73.0%–79.0% (calculated as riboflavin C₁₇H₂₀N₄O₆)
	Free Riboflavin	≤6.0% (limits unreacted starting material)
	Riboflavin Diphosphate	≤6.0% (limits specific synthesis by-products)
	Riboflavin Monophosphate	≥75.0% (ensures predominance of target active isomer)
2. Solution Properties & Safety Indicators	pH Value	5.0–6.5 (1.0% w/v aqueous solution)
	Specific Optical Rotation	[α]D20 = +37.0° to +42.0° (anhydrous basis)
	Absorbance Ratio	A373/A266 = 0.30–0.34; A445/A266 = 0.22–0.25 (structure confirmation)
3. Impurities & Limits	Loss on Drying	≤7.5% (100°C, reduced pressure, 5 h)
	Inorganic Phosphate	≤1.5% (limits hydrolysis-derived salts)
	Heavy Metals (as Pb)	≤10 ppm
	Arsenic (As)	≤2 ppm
	Residual Solvents	Ethanol ≤0.5% (5000 ppm, ICH Q3C aligned)

Quality Assurance & Certifications

Certification / Standard	Compliance & Control Scope
GMP Compliance	Manufactured under current Good Manufacturing Practices with documented production controls.
CEP/COS Certification	Holds valid Certificate of Suitability issued by EDQM for regulated market entry.
ISO 9001:2015	Certified quality management system covering synthesis through packaging stages.
FSSC 22000	Food safety management system applied to nutritional and feed applications.
Kosher & Halal	Kosher and Halal certification documents are available upon request.
ICH Q7 Guidelines	Documentation and traceability procedures follow ICH Q7 requirements.
Compendial Alignment	Testing methods aligned with relevant pharmacopeial monographs.

Manufacturing Capacity & Supply Chain

Light Protection: Processing, milling, and packaging operations utilize light-protection measures during production.

Humidity Control: Packing stations control relative humidity during handling and packaging operations.

Supply Chain Stability: Raw material reserves are maintained for production planning purposes.

Active Substance Logistics: Temperature-controlled logistics conditions are available during transportation.

Compendial Lot Control: ERP systems maintain batch records from synthesis through shipment.

Applications

Application Sector	Specific Use Case
Pharmaceuticals	Active ingredient in liquid injections and ophthalmic drops
Clinical Nutrition	Nutrient fortification in parenteral and enteral nutrition formulas
Dietary Supplements	Formulated into multivitamin syrups, tablets, and hard capsules
Functional Beverages	Nutritional fortifier in clear sports drinks
Cosmetics	Component in skin-conditioning and brightening formulations
Animal Nutrition	Additive in starter feeds and premix formulations

FAQ

Q: Why does the powder color sometimes vary slightly between manufacturing batches?

A: Minor drying variations may cause slight color differences without affecting assay results.

Q: How does the factory ensure the material remains free-flowing during high-humidity seasons?

A: Processing areas utilize desiccant-dehumidification systems to maintain strict humidity controls during crystallization and final packaging stages.

Q: Can this sodium salt form be blended directly with acidic excipients in formulations?

A: Yes, but formulations require buffering to maintain target pH and prevent precipitation of the compound.

Q: What specific shipping protocol protects the cargo from light degradation during international transit?

A: Cargo is palletized using UV-blocking stretch wrap and aluminum foil drum liners.

Q: Why is a multi-stage crystallization process utilized during the factory synthesis phase?

A: This specific chemical refinement step optimizes the ratio of the target monosodium ester against undesired diphosphate byproducts.

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