ニトロソアミン類
Nitrosamines

AB210322B

mAU
302065421031001231.

4562.

N

783.

OO

O
NNN
N

N-Nitroso-N-methyl-4-aminobutyric acid(NMBA)

4.

5.

OO

NN

N

N

N-Nitrosodiisopropylamine(NDIPA)

N-Nitrosodibutylamine(NDBA)

OColumn: YMC-Triart C18 (1.9 μm, 12 nm)
100 X 2.0 mmI.D.

Eluent: A) water/formic acid (100/0.1)
B) methanol/formic acid (100/0.05)
0-95%B (0-10 min)Flow rate: 0.2 mL/min

Temperature: 40℃

Detection: UV at 245 nm

Injection: 40 µL (10 ng/mL)O

N-Nitrosodiethylamine(NDEA)

6.

N

N-Nitrosoisopropylethylamine(NIPEA)NOH

N-Nitrosodimethylamine(NDMA)

N

min#9

ポラプレジンク （日本薬局方記載条件）
Polaprezinc (The Japanese Pharmacopoeia)(A) Standard solution*2 (0.2 mg/mL L-Carnosine)

AB210510A

O

1.

mAU
600

NOH
NH

NH2500400

L-Histidine

300
2200

2.

O

1000N

AB210427C
05

1015minNHO(B) System performance test solution*2(0.25 mg/mL L-Histidine, 0.2 mg/mL L-Carnosine)
mAU
600

OH
NH

NH2L-Carnosine

1System suitability
requirement

Result500

Elution order

1, 2

1, 2400

Resolution (1,2)≧1219300

Relative standard
deviation of the peakarea (n=6)(L-Carnosine)

≦1.0%

0.2%

2200
1000 AB210426E05Column

1015min: YMC-Triart C18 (5 μm, 12 nm)
150 X 4.6 mmI.D.

Eluent: phosphate buffer (pH 3.5)*1 containing 2.22 g/L sodium 1-octanesulfonate/acetonitrile (90/10)*1Dissolve 1.4 g of KH2PO4 in 1000 mL of water, adjust pH 3.5 with 1% H3PO4.

Flow rate: 1.35 mL/min (adjust the flow rate so that the retention time of L-Carnosine is about 15 min)Temperature: 45℃

Detection: UV at 210 nm

Injection: 10 µL(The Japanese Pharmacopoeia 17th 2nd supplement; Assay (1) Polaprezinc)*2All system performance test and standard solutions were prepared from L-Carnosine supplied as a reagent
for laboratory use.

ポラプレジンク顆粒 （日本薬局方記載条件）
Polaprezinc Granules (The Japanese Pharmacopoeia)

Standard solution*2(0.25 mg/mL 4-Aminoacetophenone,0.4 mg/mL L-Carnosine)

mAU
300

AB210427A

System suitability
requirement

ResultElution order

1, 21, 2Resolution (1,2)≧612Relative standard
deviation of the ratioof the peak area (n=6)(L-Carnosine to I.S.)

≦1.0%

0.1%

11.

O

200
H2N

24-Aminoacetophenone (I.S.)

100
2.

O

N0OH
NHNH

O

NH2L-Carnosine

0Column

51015min: YMC-Triart C18 (5 μm, 12 nm)
150 X 4.6 mmI.D.

Eluent: phosphate buffer (pH 3.5)*1 containing 2.22 g/L sodium 1-octanesulfonate/acetonitrile (90/10)*1Dissolve 1.4 g of KH2PO4 in 1000 mL of water, adjust pH 3.5 with 1% H3PO4.

Flow rate: 1.35 mL/min (adjust the flow rate so that the retention time of L-Carnosine is about 15 min)Temperature: 45℃Detection: UV at 210 nm

Injection: 5 µL(The Japanese Pharmacopoeia 17th 2nd supplement; Assay)*2Standard solution was prepared from L-Carnosine supplied as a reagent for laboratory use.

ナファモスタットおよび代謝物
Nafamostat and its metabolites

AA210326A

mV
200

3
1150

2

100

50002
H2N

1.

4NH

6min

3.

HN･HCl

H2NNHOH3C S OHHNOHOO

p-Guanidinobenzoic acid hydrochloride
OH2.
H2N･HCl

6-Amidino-2-naphthol hydrochlorideEluent

Flow rate
Temperature
Detection
InjectionO

Nafamostat mesilate

NHColumn2O: YMC-Triart C18 (1.9 μm, 12 nm)
50 X 2.1 mmI.D.
: A) water/formic acid (100/0.1)
B) methanol/formic acid (100/0.1)
5-35%B (0-6 min), 35%B (6-8 min): 0.21 mL/min: 40C: UV at 260 nm: 2 μL (0.016 ~ 0.033 mg/mL)

NH2NH