GB 1903.53-2021

National Food Safety Standard Food Nutritional Fortifier D-Calcium Pantothenate (English Version)

Standard No.

GB 1903.53-2021

Language

Chinese, Available in English version

Release Date

2021

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB 1903.53-2021

Scope

This standard is applicable to the food nutrition fortifier D-calcium pantothenate obtained by the acylation reaction of β-alanine calcium and D-pantolactone. 2 Chemical name, molecular formula, structural formula and relative molecular mass

Introduction

In-depth analysis of chemical properties and technical indicators

The molecular formula of D-calcium pantothenate C₁₈H₃₂CaN₂O₁₀ shows its organic complex calcium characteristics, and the relative molecular mass of 476.54 is precisely controlled within the error range of ±3‰.

Indicator type	Key parameter	Inactive substance limit
Main component content	97.0-103.0%	Loss on drying≤5.0%
Special impurities	β-Alanine≤0.5%	Chloride≤200mg/kg
Heavy metal control	Lead≤0.5mg/kg, total arsenic≤0.5mg/kg

Note: Special attention should be paid to the requirement that the optical rotation [α]° should be in the range of +25.0 to +27.5. This parameter has a veto significance for product quality assessment.

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Interpretation of the innovation points of inspection technology

Key to quality control of chromatography

Chromatographic conditions	Column specifications	Heating requirements	Passivation standard
Mobile phase	C18(5μm)	35±0.5℃ temperature control	Pantothenic acid-sodium pantothenate separation ≥1.5
Injection volume	＞10μL sensitivity	Unopened acetonitrile	Pressure drift ≤1MPa/h

Emergency handling plan

• Peak lysis remediation process: adjust the pH of MHA buffer solution (±0.02 error)
• Baseline drift strong self-healing mode: activated borosilicate pretreatment to enhance column efficiency

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Standard execution distress scenario simulation

Abnormal parameters	Blocking mechanism	Verification path
Detected abnormal broadening of single peak	Enabled buffer salt secondary dehydration scheme	Turbidity decayed for up to five cycles
Deuterium lamp energy dropped suddenly	Switch space-segment segmentation principle	Clone transferase value self-consistent

*Key tips for biological environmental protection: Mercury lamp tubes need to be replaced regularly)

To prevent calibration superposition error aggregation, select Flakes-Free certified voltage regulator to ensure the integrity of the command and control system.