GB 1903.13-2016 English PDF (GB1903.13-2016)

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GB 1903.13-2016: Food additive -- Levocarnitine
GB 1903.13-2016
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National food safety standard - Food nutrient fortifier -
Levocarnitine (L-carnitine)
ISSUED ON: DECEMBER 23, 2016
IMPLEMENTED ON: JUNE 23, 2017
Issued by: National Health and Family Planning Commission of PRC;
National Medical Products Administration.
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Chemical name, structural formula, molecular formula, relative molecular
mass ... 4 
3 Technical requirements ... 4 
Appendix A Inspection method ... 6 
Appendix B Infrared spectrum... 8 
National food safety standard - Food nutrient fortifier -
Levocarnitine (L-carnitine)
1 Scope
This standard applies to the food nutrient fortifier Levocarnitine (L-carnitine),
which is made through chemical synthesis, using epichlorohydrin or ethyl 4-
chloroacetoacetate as raw material, OR through microbial fermentation, using
betaine as raw material.
2 Chemical name, structural formula, molecular
formula, relative molecular mass
2.1 Chemical name
(R)-3-carboxy-2-hydroxy-N,N,N-trimethylpropylammonium hydroxide inner salt
2.2 Structural formula
2.3 Molecular formula
C7H15NO3
2.4 Relative molecular mass
161.20 (according to 2011 international relative atomic mass)
3 Technical requirements
3.1 Sensory requirements
Sensory requirements shall meet the requirements of Table 1.
Appendix A
Inspection method
A.1 General provisions
For the reagents and water used in this standard, unless otherwise specified,
they all refer to the analytical reagents and the grade-3 water, which are
specified in GB/T 6682. The standard solutions used in the test, the standard
solutions for impurity determination, the preparations and products, are
prepared in accordance with GB/T 601, GB/T 602, GB/T 603, unless otherwise
specified. The solution used in the test refers to an aqueous solution, when it is
not specified which solvent is used to prepare it.
A.2 Identification test
Use the potassium bromide smear method, to determine the infrared absorption
spectrum, in accordance with GB/T 6040. The measured infrared spectrum
shall be consistent with the standard L-carnitine spectrum (see Figure B.1).
A.3 Determination of L-carnitine content (calculated on a dry basis)
A.3.1 Reagents and materials
A.3.1.1 Glacial acetic acid.
A.3.1.2 Standard titration solution of perchloric acid: c(HClO4) = 0.1 mol/L.
A.3.2 Instruments and equipment
Potentiometric titrator: Equipped with glass electrodes.
A.3.3 Analytical procedures
Weigh about 0.1 g (accurate to 0.0001 g) of the specimen, which had been
dried to constant weight. Add 20 mL of glacial acetic acid. Use perchloric acid
standard titration solution, to perform potentiometric titration. The titration result
is corrected by a blank test.
A.3.4 Result calculation
The mass fraction w1 of L-carnitine content (calculated on a dry basis) is
calculated according to formula (A.1):