Revision of the Specifications and Standards for Foods, Food Additives, Etc. 
 
The government of Japan will establish the specifications of Iso-α-bitter Acids, Higher Fatty 
Acid (Caprylic Acid), Higher Fatty Acid (Capric Acid), Higher Fatty Acid (Stearic Acid), Higher 
Fatty Acid (Palmitic Acid), Higher Fatty Acid (Behenic Acid), Higher Fatty Acid (Myristic Acid), 
Higher Fatty Acid (Lauric Acid) and Quicklime, and revise the specifications of Ethyl 
Acetoacetate. 
 
Summary 
Japan prohibits the sale, production, import, processing, usage, storage, or display of food 
additives that are not designated by the Minister of Health, Labour and Welfare (hereinafter 
referred to as “the Minister”) under Article 10 of the Food Sanitation Act (Act No. 233 of 1947; 
hereinafter referred to as “the Act”) for the purpose of marketing. In addition, when 
specifications or standards for food additives are stipulated in the Specifications and Standards 
for Foods, Food Additives, Etc. (Ministry of Health and Welfare Notification No. 370, 1959) 
pursuant to Article 11 of the Act, Japan prohibits the sale, production, import, processing, usage, 
storage, or display of food additives for the purpose of marketing of those food additives unless 
they meet the specifications or the standards. 
 
In response to a request from the Minister, the Committee on Food Additives of the Food 
Sanitation Council under the Pharmaceutical Affairs and Food Sanitation Council (hereinafter 
referred to as “the Committee”) has discussed the adequacy of the establishment of the 
specifications for Iso-α-bitter Acids, Higher Fatty Acid (Caprylic Acid), Higher Fatty Acid 
(Capric Acid), Higher Fatty Acid (Stearic Acid), Higher Fatty Acid (Palmitic Acid), Higher Fatty 
Acid (Behenic Acid), Higher Fatty Acid (Myristic Acid), Higher Fatty Acid (Lauric Acid) and 
Quicklime, and revision of the specifications of Ethyl Acetoacetate. The conclusion of the 
Committee is outlined below. 
 
Outline of conclusion  
The Minister should establish the specifications of Iso-α-bitter Acids, Higher Fatty Acid 
(Caprylic Acid), Higher Fatty Acid (Capric Acid), Higher Fatty Acid (Stearic Acid), Higher Fatty 
Acid (Palmitic Acid), Higher Fatty Acid (Behenic Acid), Higher Fatty Acid (Myristic Acid), 
Higher Fatty Acid (Lauric Acid) and Quicklime, and revise the specifications of Ethyl 
Acetoacetate pursuant to Article 11 of the Act (see Attachment for the details). 
  Attachment 
 
Iso-α-bitter Acids 
イソアルファー苦味酸 
 
Compositional Specifications (draft) 
Definition  Iso-α-bitter Acids are obtained by the flowers of the hops (Humulus lupulus L.). They 
consist mainly of isohumulones. 
Content  Iso-α-bitter Acids contain not less than 20.0% of iso-α-bitter acids. 
Description  Iso-α-bitter Acids occur as yellow-brown liquids. They have a characteristic odor and 
a strongly bitter taste. 
Identification 
Analyze the test solution and the standard solution prepared as directed in the Assay by liquid 
chromatography using operating conditions specified in the Assay. Three of the peaks from the test 
solution correspond to the retention times of main peaks from the standard solution, respectively. 
Purity 
(1) Lead  Not more than 2 μg/g as Pb (2.0 g, Method 1, Control Solution: Lead Standard Solution 
4.0 mL, Flame Method). 
(2) Arsenic  Not more than 1.5 μg/g as As (1.0 g, Method 4, Standard Color: Arsenic Standard 
Solution 3.0 mL, Apparatus B). 
Assay 
Test Solution  Weigh accurately about 0.1 g of the sample, and dissolve it in a 500 : 1 mixture 
of methanol/phosphoric acid TS (0.1 mol/L) to make exactly 100 mL. To exactly 10 mL of this solution, 
add a 500 : 1 mixture of methanol/phosphoric acid TS (0.1 mol/L) to make exactly 50 mL. If the 
solution is turbid, filter it through with a membrane filter (0.45 μm pore size). 
Standard Solution  Weigh accurately about 50 mg of iso-α-bitter acids for assay. Add a 500 : 1 
mixture of methanol/phosphoric acid TS (0.1 mol/L) to make exactly 100 mL. To exactly 10 mL of 
this solution, add a 500 : 1 mixture of methanol/phosphoric acid TS (0.1 mol/L) to make exactly 50 
mL. 
Procedure  Analyze 10-μL portions of the test solution and the standard solution by gas 
chromatography using the operating conditions given below. For the standard solution, three main 
peaks appear in the order of isocohumulone, isohumulone, and isoadhumulone. Sum up the peak 
areas of all the peaks between the retention times of isocohumulone and isoadhumulone in the test 
solution, and determine the content of iso-α-bitter acids by the formula: Content (%) of iso--bitter acids = a ×b × AA
M × AS×1000   
a = weight (mg) of iso-α-bitter acids for assay. 
b = content (%) of iso-α-bitter acids in iso-α-bitter acids for assay. 
AA = total area of all the peaks between the retention times of isocohumulone and 
isoadhumulone in the test solution. 
AS = total area of the three main peaks from the standard solution. 
M = weight (g) of the sample. 
 
Operating conditions 
Detector: Ultraviolet spectrophotometer (wavelength: 270 nm). 
Column: A stainless steel tube (4.6 mm internal diameter and 25 cm length). 
Column packing material: 5-μm octadecylsilanized silica gel for liquid chromatography. 
Column temperature: 35C. 
Mobile phase: A 75 : 24 : 1 mixture of methanol/water/phosphoric acid. 
Flow rate: 1 mL/min. 
 
Reagents, Solutions, and Other Reference Materials 
Iso-α-bitter Acids for Assay  An international calibration standard (DCHA-Iso) with a known 
concentration, which is approved by the International Hop Standards Committee. It is a mixture of 
isohumulone, isoadhumulone, and isocohumulone and their isomers. Use the content (%) of the 
total iso-α-bitter acids as the content (%) of iso-α-bitter acids. 
Phosphoric Acid TS (0.1 mol/L)  Add water to 11.5 g of phosphoric acid to make 1000 mL. 
 
  Higher Fatty Acid (Caprylic Acid) 
高級脂肪酸（カプリル酸） 
 
Compositional Specifications (draft) 
 
Substance Name  Higher Fatty Acid (Caprylic Acid) 
Definition  Higher Fatty Acid (Caprylic Acid) is one of the higher fatty acids                                                                                                                             
(substances that are obtained by hydrolyzing animal or vegetable fats or oils or hydrogenated animal 
or vegetable fats or oils). It consists mainly of caprylic acid. 
Content  Higher Fatty Acid (Caprylic Acid) contains not less than 50.0% of caprylic acid (C8H16O2 
= 144.21). 
Description  Higher Fatty Acid (Caprylic Acid) occurs as a colorless to light yellow liquid or a white 
to bright grayish yellow paste. 
Identification  Analyze the test solution and the standard solution prepared as directed in the Assay 
by gas chromatography using the operating conditions specified in the Assay. The retention time of 
the main peak from the test solution corresponds to that of the peak of methyl caprylate from the 
standard solution. 
Iodine Value  Not more than 0.5. 
Purity  
(1) Acid value 380−395. 
(2) Lead  Not more than 2 μg/g as Pb (2.0 g, Method 1, Control Solution: Lead Standard Solution 
4.0 mL, Flame Method).  
(3) Arsenic  Not more than 3 μg/g as As (0.50 g, Method 3, Standard Color: Arsenic Standard 
Solution 3.0 mL, Apparatus B). 
Residue on Ignition  Not more than 0.1%. 
Assay   
Test Solution  Weigh 20 mg of Higher Fatty Acid (Caprylic Acid), and transfer it into a small 
conical flask fitted with a reflux condenser. Add 5 mL of boron trifluoride−methanol TS, shake, and 
heat for about 10 minutes until it dissolves. Add through the condenser 4 mL of hexane, and heat 
for 10 minutes. After cooling, add 20 mL of a saturate solution of sodium chloride, shake, and leave 
to stand to allow the solution to separate into two layers. Transfer 2 mL of the separated hexane 
layer into another flask through about 0.2 g of sodium sulfate previously washed with hexane. To 1 
mL of this solution, add hexane to make 10 mL, and shake. 
Standard Solution  Dissolve 10 mg of methyl caprylate by adding 5 mL of hexane. 
Procedure  Analyze 1-L portions of the test solution and the standard solution by gas chromatography using the operating conditions given below. Determine the peak area (AA) of methyl 
caprylate and the total peak area (AT) of all the fatty acid esters (total peak area of all peaks detected) 
in the test solution, and calculate the caprylic acid content in the fatty acid fraction of the sample by 
the following formula. Identification of methyl caprylate should be confirmed by comparing the 
retention time of the main peak from the test solution with that of methyl caprylate in the standard 
solution. The chromatography should be continued for 1.5 times the retention time of methyl 
caprylate, and the main solvent peak should be excluded from the measurement. 
             Content (%) of caprylic acid=  ×100 
Operating conditions 
Detector: Flame ionization detector. 
Column: A fused silica tube (0.25 mm internal diameter and 50 m length) coated with a 0.2-
m thick layer of 100% cyanopropylpolysiloxane for gas chromatography. 
Column temperature: 180°C. 
Injection port temperature: 250°C. 
Detector temperature: 250°C. 
Carrier gas: Helium. 
Flow rate: A constant rate of about 1.0 mL/min. 
    Injection method: Splitless. 
 
Reagents, Solutions, and Other Reference Materials 
Methyl Caprylate  See Methyl Octanate. 
Methyl Octanate  C9H18O2  [111-11-5]  A colorless, clear liquid. 
Refractive index  n: 1.415−1.420. 
Density  0.874−0.880 g/mL (20°C). 
 
  Higher Fatty Acid (Capric Acid) 
高級脂肪酸（カプリン酸） 
 
Compositional Specifications (draft) 
 
Substance Name  Higher Fatty Acid (Capric Acid) 
Definition  Higher Fatty Acid (Capric Acid) is one of the higher fatty acids (substances that are 
obtained by hydrolyzing animal or vegetable fats or oils or hydrogenated animal or vegetable fats or 
oils ). It consists mainly of capric acid. 
Content  Higher Fatty Acid (Capric Acid) contains not less than 50.0% of capric acid (C10H20O2 = 
172.26). 
Description  Higher Fatty Acid (Capric Acid) occurs as white to bright grayish yellow flakes, powder, 
or granules or as a waxy lump. 
Identification  Analyze the test solution and the standard solution prepared as directed in the Assay 
by gas chromatography using the operating conditions specified in the Assay. The retention time of 
the main peak from the test solution corresponds to that of the peak of methyl caprate from the 
standard solution. 
Iodine Value  Not more than 0.5. 
Purity  
(1) Acid value 321−333. 
(2) Lead  Not more than 2 μg/g as Pb (2.0 g, Method 1, Control Solution: Lead Standard Solution 
4.0 mL, Flame Method). 
(3) Arsenic  Not more than 3 μg/g as As (0.50 g, Method 3, Standard Color: Arsenic Standard 
Solution 3.0 mL, Apparatus B). 
Residue on Ignition  Not more than 0.1%. 
Assay 
Test Solution  Weigh 20 mg of Higher Fatty Acid (Capric Acid), and transfer it into a small 
conical flask fitted with a reflux condenser. Add 5 mL of boron trifluoride−methanol TS, shake, and 
heat for about 10 minutes until it dissolves. Add through the condenser 4 mL of hexane, and heat 
for 10 minutes. After cooling, add 20 mL of a saturate solution of sodium chloride, shake, and leave 
to stand to allow the solution to separate into two layers. Transfer 2 mL of the separated hexane 
layer into another flask through about 0.2 g of sodium sulfate previously washed with hexane. To 1 
mL of this solution, add hexane to make 10 mL, and shake. 
Standard Solution  Dissolve 10 mg of methyl caprate by adding 5 mL of hexane. 
Procedure  Analyze 1-L portions of the test solution and the standard solution by gas chromatography using the operating conditions given below. Determine the peak area (AA) of methyl 
caprate and the total peak area (AT) of all the fatty acid esters (total peak area of all peaks detected) 
in the test solution, and calculate the capric acid content in the fatty acid fraction of the sample by 
the following formula. Identification of methyl caprate should be confirmed by comparing the 
retention time of the main peak from the test solution with that of methyl caprate in the standard 
solution. The chromatography should be continued for 1.5 times the retention time of methyl caprate, 
and the main solvent peak should be excluded from the measurement. 
             Content (%) of capric acid=  ×100 
Operating conditions 
Detector: Flame ionization detector. 
Column: A fused silica tube (0.25 mm internal diameter and 50 m length) coated with a 0.2-
m thick layer of 100% cyanopropylpolysiloxane for gas chromatography. 
Column temperature: 180°C. 
Injection port temperature: 250°C. 
Detector temperature: 250°C. 
Carrier gas: Helium. 
Flow rate: A constant rate of about 1.0 mL/min. 
Injection method: Splitless. 
 
Reagents, Solutions, and Other Reference Materials 
Methyl Caprate  See Methyl Decanoate. 
Methyl Decanoate  C11H22O2  [110-42-9]  A colorless, clear liquid. 
Refractive index  n: 1.424−1.427. 
Specific gravity  d: 0.872−0.876. 
 
  Higher Fatty Acid (Stearic Acid) 
高級脂肪酸（ステアリン酸） 
 
Compositional Specifications (draft) 
 
Substance Name  Higher Fatty Acid (Stearic Acid) 
Definition  Higher Fatty Acid (Stearic Acid) is one of the higher fatty acids (substances that are 
obtained by hydrolyzing animal or vegetable fats or oils or hydrogenated animal or vegetable fats or 
oils ) It consists mainly of stearic acid. 
Content  Higher Fatty Acid (stearic Acid) contains not less than 50.0% of stearic acid (C18H36O2 = 
284.48). 
Description  Higher Fatty Acid (Stearic Acid) occurs as white to bright grayish yellow flakes, 
powder, or granules or as a waxy lump. 
Identification  Analyze the test solution and the standard solution prepared as directed in the Assay 
by gas chromatography using the operating conditions specified in the Assay. The retention time of 
the main peak from the test solution corresponds to that of the peak of methyl stearate from the 
standard solution.  
Iodine Value  Not more than 4.0. 
Test Solution  Weigh accurately about 1 g of Higher Fatty Acid (Stearic Acid) into a 500-mL 
stoppered flask, and dissolve it in 20 mL of a 1 : 1 mixture of cyclohexane/chloroform. 
Procedure Proceed as directed under Iodine Value in the Fats and Related Substances Tests. 
Purity  
(1) Acid value  194−210. 
(2) Lead  Not more than 2 μg/g as Pb (2.0 g, Method 1, Control Solution: Lead Standard Solution 
4.0 mL, Flame Method).  
(3) Arsenic  Not more than 3 μg/g as As (0.50 g, Method 3, Standard Color: Arsenic Standard 
Solution 3.0 mL, Apparatus B). 
Residue on Ignition  Not more than 0.1%. 
Assay 
Test Solution  Weigh 20 mg of Higher Fatty Acid (Stearic Acid), and transfer it into a small 
conical flask fitted with a reflux condenser. Add 5 mL of boron trifluoride−methanol TS, shake, and 
heat for about 10 minutes until it dissolves. Add through the condenser 4 mL of hexane, and heat 
for 10 minutes. After cooling, add 20 mL of a saturate solution of sodium chloride, shake, and leave 
to stand to allow the solution to separate into two layers. Transfer 2 mL of the separated hexane 
layer into another flask through about 0.2 g of sodium sulfate previously washed with hexane. To 1 mL of this solution, add hexane to make 10 mL, and shake.  
Standard Solution  Dissolve 10 mg of methyl stearate by adding 5 mL of hexane.   
Procedure  Analyze 1-L portions of the test solution and the standard solution by gas 
chromatography using the operating conditions given below. Determine the peak area (AA) of methyl 
stearate and the total peak area (AT) of all the fatty acid esters (total peak area of all peaks detected) 
in the test solution, and calculate the stearic acid content in the fatty acid fraction of the sample by 
the following formula. Identification of methyl stearate should be confirmed by comparing the 
retention time of the main peak from the test solution with that of methyl stearate in the standard 
solution. The chromatography should be continued for 1.5 times the retention time of methyl 
stearate, and the main solvent peak should be excluded from the measurement. 
             Content (%) of stearic acid=  ×100 
Operating conditions 
Detector: Flame ionization detector. 
Column: A fused silica tube (0.25 mm internal diameter and 50 m length) coated with a 0.2-
m thick layer of 100% cyanopropylpolysiloxane for gas chromatography. 
Column temperature: 180°C. 
Injection port temperature: 250°C. 
Detector temperature: 250°C. 
Carrier gas: Helium. 
Flow rate: A constant rate of about 1.0 mL/min. 
Injection method: Splitless. 
  Higher Fatty Acid (Palmitic Acid) 
高級脂肪酸（パルミチン酸） 
 
Compositional Specifications (draft) 
 
Substance Name  Higher Fatty Acid (Palmitic Acid) 
Definition  Higher Fatty Acid (Palmitic Acid) is one of the higher fatty acids (substances that are 
obtained by hydrolyzing animal or vegetable fats or oils or hydrogenated animal or vegetable fats or 
oils). It consists mainly of palmitic acid.  
Content  Higher Fatty Acid (Palmitic Acid) contains not less than 50.0% of palmitic acid (C16H32O2 
= 256.42). 
Description  Higher Fatty Acid (Palmitic Acid) occurs as white to bright grayish yellow flakes, 
powder, or granules or as a waxy lump.  
Identification  Analyze the test solution and the standard solution prepared as directed in the Assay 
by gas chromatography using the operating conditions specified in the Assay. The retention time of 
the main peak from the test solution corresponds to that of the peak of methyl palmitate from the 
standard solution.  
Iodine Value  Not more than 2.0. 
Test Solution  Weigh accurately about 1 g of Higher Fatty Acid (Palmitic Acid) into a 500-mL 
stoppered flask, and dissolve it in 20 mL of a 1 : 1 mixture of cyclohexane/chloroform. 
Procedure  Proceed as directed under Iodine Value in the Fats and Related Substances Tests. 
Purity  
(1) Acid value 212−222. 
(2) Lead  Not more than 2 μg/g as Pb (2.0 g, Method 1, Control Solution: Lead Standard Solution 
4.0 mL, Flame Method).  
(3) Arsenic  Not more than 3 μg/g as As (0.50 g, Method 3, Standard Color: Arsenic Standard 
Solution 3.0 mL, Apparatus B). 
Residue on Ignition  Not more than 0.1%. 
Assay 
Test Solution  Weigh 20 mg of Higher Fatty Acid (Palmitic Acid), and transfer it into a small 
conical flask fitted with a reflux condenser. Add 5 mL of boron trifluoride−methanol TS, shake, and 
heat for about 10 minutes until it dissolves. Add through the condenser 4 mL of hexane, and heat 
for 10 minutes. After cooling, add 20 mL of a saturate solution of sodium chloride, shake, and leave 
to stand to allow the solution to separate into two layers. Transfer 2 mL of the separated hexane 
layer into another flask through about 0.2 g of sodium sulfate previously washed with hexane. To 1 mL of this solution, add hexane to make 10 mL, and shake. 
Standard Solution  Dissolve 10 mg of methyl palmitate by adding 5 mL of hexane. 
Procedure  Analyze 1-L portions of the test solution and the standard solution by gas 
chromatography using the operating conditions given below. Determine the peak area (AA) of methyl 
palmitate and the total peak area (AT) of all the fatty acid esters (total peak area of all peaks 
detected) in the test solution, and calculate the palmitic acid content in the fatty acid fraction of the 
sample by the following formula. Identification of methyl palmitate should be confirmed by 
comparing the retention time of the main peak from the test solution with that of methyl palmitate 
in the standard solution. The chromatography should be continued for 1.5 times the retention time 
of methyl palmitate, and the main solvent peak should be excluded from the measurement. 
             Content (%) of palmitic acid=  ×100 
Operating conditions 
Detector: Flame ionization detector. 
Column: A fused silica tube (0.25 mm internal diameter and 50 m length) coated with a 0.2-
m thick layer of 100% cyanopropylpolysiloxane for gas chromatography. 
Column temperature: 180°C. 
Injection port temperature: 250°C. 
Detector temperature: 250°C. 
Carrier gas: Helium. 
Flow rate: A constant rate of about 1.0 mL/min. 
Injection method: Splitless. 
 
  Higher Fatty Acid (Behenic Acid) 
高級脂肪酸（ベヘニン酸） 
 
Compositional Specifications (draft) 
 
Substance Name   Higher Fatty Acid (Behenic Acid) 
Definition  Higher Fatty Acid (Behenic Acid) is one of the higher fatty acids (substances that are 
obtained by hydrolyzing animal or vegetable fats or oils or hydrogenated animal or vegetable fats or 
oils). It consists mainly of behenic acid.  
Content  Higher Fatty Acid (Behenic Acid) contains not less than 50.0% of behenic acid (C22H44O2 
= 340.58). 
Description  Higher Fatty Acid (Behenic Acid) occurs as white to bright grayish yellow flakes, 
powder, or granules or as a waxy lump. 
Identification  Analyze the test solution and the standard solution prepared as directed in the 
Assay by gas chromatography using the operating conditions specified in the Assay. The retention 
time of the main peak from the test solution corresponds to that of the peak of methyl behenate from 
the standard solution.  
Iodine Value  Not more than 3.0. 
Test Solution  Weigh accurately about 1 g of Higher Fatty Acid (Behenic Acid) into a 500-mL 
stoppered flask, and dissolve it in 20 mL of a 1 : 1 mixture of cyclohexane/chloroform. 
Procedure  Proceed as directed under Iodine Value in the Fats and Related Substances Tests. 
Purity  
(1) Acid value 160−175. 
(2) Lead  Not more than 2 μg/g as Pb (2.0 g, Method 1, Control Solution: Lead Standard Solution 
4.0 mL, Flame Method).  
(3) Arsenic  Not more than 3 μg/g as As (0.50 g, Method 3, Standard Color: Arsenic Standard 
Solution 3.0 mL, Apparatus B). 
Residue on Ignition  Not more than 0.1%. 
Assay 
Test Solution  Weigh 20 mg of Higher Fatty Acid (Behenic Acid), and transfer it into a small 
conical flask fitted with a reflux condenser. Add 5 mL of boron trifluoride−methanol TS, shake, and 
heat for about 10 minutes until it dissolves. Add through the condenser 4 mL of hexane, and heat 
for 10 minutes. After cooling, add 20 mL of a saturate solution of sodium chloride, shake, and leave 
to stand to allow the solution to separate into two layers. Transfer 2 mL of the separated hexane 
layer into another flask through about 0.2 g of sodium sulfate previously washed with hexane. To 1 mL of this solution, add hexane to make 10 mL, and shake. 
Standard Solution  Dissolve 10 mg of methyl behenate by adding 5 mL of hexane.   
Procedure  Analyze 1-L portions of the test solution and the standard solution by gas 
chromatography using the operating conditions given below. Determine the peak area (AA) of methyl 
behenate and the total peak area (AT) of all the fatty acid esters (total peak area of all peaks detected) 
in the test solution, and calculate the behenic acid content in the fatty acid fraction of the sample by 
the following formula. Identification of methyl behenate should be confirmed by comparing the 
retention time of the main peak from the test solution with that of methyl behenate in the standard 
solution. The chromatography should be continued for 1.5 times the retention time of methyl 
behenate, and the main solvent peak should be excluded from the measurement. 
             Content (%) of behenic acid=  ×100 
Operating conditions 
Detector: Flame ionization detector. 
Column: A fused silica tube (0.25 mm internal diameter and 50 m length) coated with a 0.2-
m thick layer of 100% cyanopropylpolysiloxane for gas chromatography. 
Column temperature: 180°C. 
Injection port temperature: 250°C. 
Detector temperature: 250°C. 
Carrier gas: Helium. 
Flow rate: A constant rate of about 1.0 mL/min. 
    Injection method: Splitless. 
 
Reagents, Solutions, and Other Reference Materials 
Methyl Behenate  See Methyl Docosanoate. 
Methyl Docosanoate  C23H46O2  [929-77-1]  A colorless crystalline powder. 
Melting point  53−56°C. 
 
  Higher Fatty Acid (Myristic Acid) 
高級脂肪酸（ミリスチン酸） 
 
Compositional Specifications (draft) 
 
Substance Name  Higher Fatty Acid (Myristic Acid) 
Definition  Higher Fatty Acid (Myristic Acid) is one of the higher fatty acids (substances that are 
obtained by hydrolyzing animal or vegetable fats or oils or hydrogenated animal or vegetable fats or 
oils). It consists mainly of myristic acid.  
Content  Higher Fatty Acid (Myristic Acid) contains not less than 50.0% of myristic acid (C14H28O2 
= 228.38). 
Description  Higher Fatty Acid (Myristic Acid) occurs as white to bright grayish yellow flakes, 
powder, or granules or as a waxy lump.  
Identification  Analyze the test solution and the standard solution prepared as directed in the Assay 
by gas chromatography using the operating conditions specified in the Assay. The retention time of 
the main peak from the test solution corresponds to that of the peak of methyl myristate from the 
standard solution.  
Iodine Value  Not more than 1.0. 
Purity  
(1) Acid value 240−250. 
(2) Lead  Not more than 2 μg/g as Pb (2.0 g, Method 1, Control Solution: Lead Standard Solution 
4.0 mL, Flame Method).  
(3) Arsenic  Not more than 3 μg/g as As (0.50 g, Method 3, Standard Color: Arsenic Standard 
Solution 3.0 mL, Apparatus B). 
Residue on Ignition  Not more than 0.1%.  
Assay   
Test Solution  Weigh 20 mg of Higher Fatty Acid (Myristic Acid), and transfer it into a small 
conical flask fitted with a reflux condenser. Add 5 mL of boron trifluoride−methanol TS, shake, and 
heat for about 10 minutes until it dissolves. Add through the condenser 4 mL of hexane, and heat 
for 10 minutes. After cooling, add 20 mL of a saturate solution of sodium chloride, shake, and leave 
to stand to allow the solution to separate into two layers. Transfer 2 mL of the separated hexane 
layer into another flask through about 0.2 g of sodium sulfate previously washed with hexane. To 1 
mL of this solution, add hexane to make 10 mL, and shake.  
Standard Solution  Dissolve 10 mg of methyl myristate by adding 5 mL of hexane.   
Procedure  Analyze 1-L portions of the test solution and the standard solution by gas chromatography using the operating conditions given below. Determine the peak area (AA) of methyl 
myristate and the total peak area (AT) of all the fatty acid esters (total peak area of all peaks 
detected) in the test solution, and calculate the myristic acid content in the fatty acid fraction of the 
sample by the following formula. Identification of methyl myristate should be confirmed by 
comparing the retention time of the main peak from the test solution with that of methyl myristate 
in the standard solution. The chromatography should be continued for 1.5 times the retention time 
of methyl myristate, and the main solvent peak should be excluded from the measurement. 
             Content (%) of myristic acid=  ×100 
Operating conditions 
Detector: Flame ionization detector. 
Column: A fused silica tube (0.25 mm internal diameter and 50 m length) coated with a 0.2-
m thick layer of 100% cyanopropylpolysiloxane for gas chromatography. 
Column temperature: 180°C. 
Injection port temperature: 250°C. 
Detector temperature: 250°C. 
Carrier gas: Helium. 
Flow rate: A constant rate of about 1.0 mL/min. 
    Injection method: Splitless. 
 
Reagents, Solutions, and Other Reference Materials 
Methyl Myristate  See Methyl Tetradecanoate. 
Methyl Tetradecanoate  C15H30O2  [124-10-7]  A colorless, transparent liquid. 
Refractive index  n: 1.434−1.438. 
Specific gravity  d: 0.853−0.873. 
 
  Higher Fatty Acid (Lauric Acid) 
高級脂肪酸（ラウリン酸） 
 
Compositional Specifications (draft) 
 
Substance Name   Higher Fatty Acid (Lauric Acid) 
Definition  Higher Fatty Acid (Lauric Acid) is one of the higher fatty acids (substances that are 
obtained by hydrolyzing animal or vegetable fats or oils or hydrogenated animal or vegetable fats or 
oils). It consists mainly of lauric acid.  
Content  Higher Fatty Acid (Lauric Acid) contains not less than 50.0% of lauric acid (C12H24O2 = 
200.32). 
Description  Higher Fatty Acid (Lauric Acid) occurs as white to bright grayish yellow flakes, powder, 
or granules or as a waxy lump.  
Identification  Analyze the test solution and the standard solution prepared as directed in the Assay 
by gas chromatography using the operating conditions specified in the Assay. The retention time of 
the main peak from the test solution corresponds to that of the peak of methyl laurate from the 
standard solution.  
Iodine Value  Not more than 1.0. 
Purity  
(1) Acid value 275−285. 
(2) Lead  Not more than 2 μg/g as Pb (2.0 g, Method 1, Control Solution: Lead Standard Solution 
4.0 mL, Flame Method).  
(3) Arsenic  Not more than 3 μg/g as As (0.50 g, Method 3, Standard Color: Arsenic Standard 
Solution 3.0 mL, Apparatus B). 
Residue on Ignition  Not more than 0.1%.  
Assay   
Test Solution  Weigh 20 mg of Higher Fatty Acid (Lauric Acid), and transfer it into a small 
conical flask fitted with a reflux condenser. Add 5 mL of boron trifluoride−methanol TS, shake, and 
heat for about 10 minutes until it dissolves. Add through the condenser 4 mL of hexane, and heat 
for 10 minutes. After cooling, add 20 mL of a saturate solution of sodium chloride, shake, and leave 
to stand to allow the solution to separate into two layers. Transfer 2 mL of the separated hexane 
layer into another flask through about 0.2 g of sodium sulfate previously washed with hexane. To 1 
mL of this solution, add hexane to make 10 mL, and shake.  
Standard Solution  Dissolve 10 mg of methyl laurate by adding 5 mL of hexane.   
Procedure  Analyze 1-L portions of the test solution and the standard solution by gas chromatography using the operating conditions given below. Determine the peak area (AA) of methyl 
laurate and the total peak area (AT) of all the fatty acid esters (total peak area of all peaks detected) 
in the test solution, and calculate the lauric acid content in the fatty acid fraction of the sample by 
the following formula. Identification of methyl laurate should be confirmed by comparing the 
retention time of the main peak from the test solution with that of methyl laurate in the standard 
solution. The chromatography should be continued for 1.5 times the retention time of methyl laurate, 
and the main solvent peak should be excluded from the measurement. 
             Content (%) of lauric acid=  ×100 
Operating conditions 
Detector: Flame ionization detector. 
Column: A fused silica tube (0.25 mm internal diameter and 50 m length) coated with a 0.2-
m thick layer of 100% cyanopropylpolysiloxane for gas chromatography. 
Column temperature: 180°C. 
Injection port temperature: 250°C. 
Detector temperature: 250°C. 
Carrier gas: Helium. 
Flow rate: A constant rate of about 1.0 mL/min. 
Injection method: Splitless. 
 
  Quicklime 
生石灰 
 
Compositional Specifications (draft) 
Definition  Quicklime is obtained by calcinating limestones. It consists mainly of calcium oxide. 
Content  Quicklime, when ignited, contains not less than 93.0% of calcium oxide (CaO = 56.08). 
Description  Quicklime occurs as white to grayish-white lumps, granules, or powder. 
Identification 
(1) Moisten 1 g of Quicklime with water. It generates heat. Then add 5 mL of water. The 
resulting suspension is alkali. 
(2) To 1 g of Quicklime, add 20 mL of water and 6 mL of acetic acid (1 in 3), and filter. The 
filtrate responds to all the tests for Calcium Salt as described in the Quantitative Tests. 
Purity 
(1) Hydrochloric acid-insoluble substances  Not more than 1.0%. 
Weigh accurately a crucible-type glass filter (1G4), previously dried at 105°C for 30 minutes 
and cooled in a desiccator. Weigh 5.0 g of Quicklime, add 100 mL of water, then add hydrochloric 
acid dropwise while shaking until the sample no longer dissolves, and boil. After cooling, add 
hydrochloric acid to acidify if necessary. Filter through with the previously weighed glass filter. 
Wash the residue well on the filter with water until the washings are free of chloride. Dry the 
residue with the filter at 105°C for 1 hours. Allow to cool in a desiccator, and weigh accurately. 
(2) Carbonate  Weigh 2.0 g of Quicklime, add 50 mL of water, shake thoroughly, and add 
25 mL of diluted hydrochloric acid (1 in 4). It does not effervesce vigorously. 
(3) Lead  Not more than 5 μg/g as Pb (0.80 g, Method 5, Control Solution: Lead Standard 
Solution 4.0 mL, Flame Method). 
Sample Solution  Weigh the specified amount of Quicklime into a crucible. Heat it 
gradually to carbonize, and ignite at 500°C with a lid. Add 20 mL of diluted hydrochloric acid (1 
in 4) to the residue, cover with a watch glass, and boil calmly for 15 minutes. After cooling, add 
30 mL of water. If the sample does not dissolve, evaporate to dryness, add 20 mL of diluted 
hydrochloric acid (1 in 4) to the residue, and boil calmly for 5 minutes. After cooling, add 30 mL 
of water.   
In Method 5 of the Lead Limit Test, use 50 mL of a solution of diammonium hydrogen citrate 
(1 in 2) and 1 mL of bromothymol blue TS as the indicator instead of thymol blue TS, and then 
add ammonia solution until the color of the solution changes from yellow to yellow-green. 
(4) Alkali metals and magnesium  Not more than 6.0%. Weigh accurately about 0.5 g of Quicklime, add 30 mL of water and 15 mL of diluted 
hydrochloric acid (1 in 4) to dissolve it. Heat the solution, and boil for 1 minute. Immediately 
add 40 mL of a solution of oxalic acid dihydrate (3 in 50), agitate, and add 2 drops of methyl red 
TS, then add ammonia solution dropwise until the solution exhibits a yellow color to precipitate 
the calcium. Heat this solution on a water bath for 1 hour, cool, and add water to make 100 mL. 
Mix well, and filter. Transfer 50 mL of the filtrate into a platinum crucible, previously ignited 
at 800°C for 30 minutes, cooled in a desiccator, and weighed accurately. Add 0.5 mL of sulfuric 
acid, evaporate to dryness, ignite at 800°C to constant weight, and weigh the crucible to 
determine the weight of the residue. 
(5) Barium Not more than 300 μg /g as Ba. 
Test Solution  Weigh 1.50 g of Quicklime, and add water to make it muddy. Add 20 mL of 
diluted hydrochloric acid (1 in 4) to dissolve it, and add water to make 30 mL. Filter the solution, 
and use 20 mL of the filtrate as the test solution. 
Procedure  To the test solution, add 2 g of sodium acetate, 1 mL of diluted acetic acid (1 in 
20), and 0.5 mL of potassium chromate solution (1 in 20), and allow to stand for 15 minutes. The 
solution is not more turbid than a control solution prepared as follows: To 0.30 mL of Barium 
Standard Solution, add water to make 20 mL, and then treated in the same manner as for the 
test solution. 
(6) Arsenic  Not more than 3 μg/g as As (0.50 g, Standard Color: Arsenic Standard Solution 
3.0 mL, Apparatus B). 
Test Solution  Dissolve the specified amount of Quicklime in 8 mL of diluted hydrochloric 
acid (1 in 4). 
Loss on Ignition  Not more than 10.0% (800°C, constant weight). 
Assay  Weigh accurately about 1.5 g of Quicklime, previously ignited, add 30 mL of diluted 
hydrochloric acid (1 in 4) to dissolve, and add water to make exactly 250 mL. Use the resulting 
solution as the test solution. Proceed as directed under Method 1 in Calcium Salt Determination. 
Each mL of 0.05 mol/L disodium dihydrogen ethylenediaminetetraacetate = 2.804 mg of CaO. 
 
  Ethyl Acetoacetate 
アセト酢酸エチル 
 
 
The compositional specifications for Ethyl Acetoacetate will be revised as follows: 
 
 
Reagents, Solutions, and Other Reference Materials 
Bromocresol Purple  C21H16Br2O5S [K8841, Special Grade] [115-40-2] 
Bromocresol Purple TS  Dissolve 50 mg of bromocresol purple in 100 mL of ethanol (95). Filter if 
necessary. Revised regulation Current regulation 
Purity  
Acid value  Not more than 5.0 (Flavoring 
Substances Tests). To confirm the endpoint 
with an indicator, use bromocresol purple 
TS. The endpoint is when the color of the 
solution changes from yellow to bluish 
purple. Purity 
Acid value  Not more than 5.0  
(Flavoring Substances Tests).