クエチアピンフマル酸塩（日本薬局方記載条件）
Quetiapine fumarate (The Japanese Pharmacopoeia)

P130703AA) Assay: Standard solution*1(0.08 mg/mL Quetiapine fumarate)
System suitability
requirement

ResultTheoretical plate number(Quetiapine)

≧6000

15400

Tailing factor(Quetiapine)Tf≦2.01.07

Relative standard
deviation of the peak area(Quetiapine)

≦1.0%

0.05%

mAU
1250

1000

750

1500

250

1O

N0N
P130131E

100OHNHOOC･20 minS2B) Related substances i: Standard solution*1(0.002 mg/mL Quetiapine fumarate)

Quetiapine fumarate

mAU3020110System suitability
requirement

ResultTheoretical plate number(Quetiapine)

≧6000

15400

Tailing factor(Quetiapine)Tf≦2.01.06

Relative standard
deviation of the peak area(Quetiapine)

≦2.0%

0.13%

0P130131B

10Column: YMCbasic (5 µm, 20 nm)
250 X 4.6 mmI.D.
: phosphate buffer (pH 6.5)*2/methanol/acetonitrile (39/54/7)

Eluent2030 min02* Dissolve 2.6 g of (NH4)2HPO4 in 1000 mL of water, adjust pH 6.5 with H3PO4

Flow rate
Temperature: 0.85 mL/min (adjust the flow rate so that the retention time of quetiapine is about 15 min)
: 25℃

Detection: UV at 230 nm

Injection: 50 µL(The Japanese Pharmacopoeia 16th SupplementⅠ; Assay, Related substances i )1* All standard solutions were prepared from Quetiapine fumarate supplied as a reagent for laboratory use.

COOH

クエチアピンフマル酸塩（日本薬局方記載条件）
Quetiapine fumarate (The Japanese Pharmacopoeia)

P130201A

1ON

1Related substances ii: Standard solution*(0.002 mg/mL Quetiapine fumarate)

NOH

N

HOOC･COOH

SmAU
40

2Quetiapine fumarate
30

12010System suitability
requirement

ResultTheoretical plate number(Quetiapine)

≧3000

10900

Tailing factor(Quetiapine)Tf≦2.01.24

Relative standard
deviation of the peak area(Quetiapine)

≦2.0%

0.36%

010020Column: YMCbasic (5 µm, 20 nm)

Eluent

250 X 4.6 mmI.D.
: methanol/acetonitrile/(NH4)2HPO4 aq *2 (70/9/21)

30 min2* Dissolve 3.3 g of (NH4)2HPO4 in 1250 mL of water

Flow rate: 1.4 mL/min (adjust the flow rate so that the retention time of quetiapine is about 3.5 min)Temperature: 25℃

Detection: UV at 250 nm

Injection: 50 µL(The Japanese Pharmacopoeia 16th SupplementⅠ; Related substances ii)
1* Standard solution was prepared from Quetiapine fumarate supplied as a reagent for laboratory use.

クエチアピンフマル酸塩錠（日本薬局方記載条件）
Quetiapine fumarate tablets (The Japanese Pharmacopoeia)

P130703BA) Assay: Standard solution*1(0.18 mg/mL Quetiapine fumarate )System suitability
requirement

ResultTheoretical plate number(Quetiapine)

≧7000

15900

Tailing factor(Quetiapine)Tf≦1.5

1.07

Relative standard
deviation of the peak area(Quetiapine)≦1.0%

0.15%mAU
1500

11000

500

1N

0P130627G0NOHN

HOOC

min

20

10O･SCOOH2B) Related substances : Standard solution*(0.0015 mg/mL Quetiapine fumarate)

1

Quetiapine fumarate

mAU
System suitability
requirement

ResultTheoretical plate number(Quetiapine)

≧7000

15500

Tailing factor(Quetiapine)Tf≦1.5

1.05

Relative standard
deviation of the peak area(Quetiapine)

≦2.0%

0.56%

15

11050P130627D

020

1030minColumn: YMCbasic (5 µm, 20 nm)

Eluent

250 X 4.6 mmI.D.
: methanol/acetonitrile/(NH4)2HPO4 aq *2 (54/7/39)
2* Dissolve 3.3 g of (NH4)2HPO4 in 1250 mL of water

Flow rate
Temperature: 0.85 mL/min (adjust the flow rate so that the retention time of quetiapine is about 15 min)
: 25℃Detection: UV at 230 nm

Injection: 50 µL(The Japanese Pharmacopoeia 16th SupplementⅠ; Assay, Related substances)1* All standard solutions were prepared from Quetiapine fumarate supplied as a reagent for laboratory use.

クエチアピンフマル酸塩錠
Quetiapine fumarate fine tablets

P130808D

Dissolution: Standard solution*1(0.016 mg/mL Quetiapine fumarate)

1NNOOHN

HOOC･COOHS2mAU

Quetiapine fumarate

3002001100

System suitability
requirement

ResultTheoretical plate number(Quetiapine)

≧1400

3800

Tailling factor(Quetiapine)Tf≦1.5

1.15

Relative standard
deviation of the peak area(Quetiapine)

≦2.0%

0.10%

05010Column: YMCbasic (5 µm, 20 nm)

Eluent75 X 4.6 mmI.D.
: methanol/acetonitrile/(NH4)2HPO4 aq *2 (54/7/39)

min2* Dissolve 3.3 g of (NH4)2HPO4 in 1250 mL of water

Flow rate: 1.0 mL/min (adjust the flow rate so that the retention time of quetiapine is about 4 min)Temperature: 25℃

Detection: UV at 230 nm

Injection: 50 µL(Modified condition of The Japanese Pharmacopoeia 16th SupplementⅠ; Dissolution)
1* Standard solution was prepared from Quetiapine fumarate supplied as a reagent for laboratory use.

クエチアピンフマル酸塩細粒（日本薬局方記載条件）
Quetiapine fumarate fine granules (The Japanese Pharmacopoeia)
Assay: Standard solution*1(0.17 mg/mL Quetiapine fumarate)

P130627B

1NN

O
OH

N

HOOC･S

COOH

2mAU

Quetiapine fumarate

1500

11000500

System suitability
requirement

ResultTheoretical plate number(Quetiapine)≧7000

15900

Tailling factor(Quetiapine)Tf≦1.5

1.07

Relative standard
deviation of the peak area(Quetiapine)

≦1.0%

0.14%

010020Column: YMCbasic (5 µm, 20 nm)

Eluent

250 X 4.6 mmI.D.
: methanol/acetonitrile/(NH4)2HPO4 aq *2 (54/7/39)

min

2* Dissolve 3.3 g of (NH4)2HPO4 in 1250 mL of water

Flow rate: 0.85 mL/min (adjust the flow rate so that the retention time of quetiapine is about 15 min)Temperature: 25℃

Detection: UV at 230 nm

Injection: 50 µL(The Japanese Pharmacopoeia 16th SupplementⅠ; Assay)
1* Standard solution was prepared from Quetiapine fumarate supplied as a reagent for laboratory use.