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第二章 药物的杂质检查 PowerPoint PPT Presentation


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第二章 药物的杂质检查. 第一节 概述. 一、药物的纯度要求. 指药物纯净程度,反映了药物质量的优劣,含有杂质是影响药物纯度的主要因素。. 杂质( forin 、 impurities ) 是指: 1. 有毒副作用的物质 2. 本身无毒副作用,但影响药物的稳定性和疗效的物质 3. 本身无毒副作用,也不影响药物的稳定性和疗效,但影响药物的科学管理的物质. 二、杂质的来源与种类 (一)杂质的来源. ( 1 )原料、反应中间体及副产物. ( 2 )试剂、溶剂、催化剂类. 1. 生产过程中引入.

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第二章 药物的杂质检查

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forinimpurities

1.

2.

3.


1

2

1.

3


96131

A.

B.

C.

D.

E.


2.



1.


2.


99x851995

A.

B.

C.

D.

E.


GRARCP


  • .

    • A.

    • B.

    • C.

    • D.

    • E.


ppm



1.

Limit Test


2.


3.

pH



97712ml1ml1gAs0.0001

A. 0.20g B. 2.0g C0.020g

D. 1.0g E. 0.10g


c1 g/ml1106 g/ml

V2ml L0.0001%


9679C1.0g1ml0.01mgPbml

A. 0.2ml B. 0.4ml C2ml

D. 1ml E. 20ml


1.


1 2mm

2


2. 1g2%1g1%

3.

4.



25ml10m150ml


40m1

50ml10m140m1


1.0m150m15


1. NaCl 10gCl/ml50ml5080gClNaCl58ml

2. 50ml10ml


1AgCl

2

3


3.

4.

5. 5


6.

7.


1.

1

2


2.

1

2

3


3.

1

2

3


4.


  • 9582. B

    • A. B.

    • C. D.

    • E.


  • 1. 2000 10gCl/ml58mlD

    • A.

    • B.

    • C.

    • D.

    • E.


  • 2. ABCDE

    • A

    • B

    • C

    • D

    • E


  • 3. AB

    • A

    • B

    • C

    • D

  • E


    • 4. D

      • A.

      • B.

      • C.

      • D.

      • E.


    • 5. ABC

      • A.

      • B. (10ml/50ml)

      • C. 5

      • D.

      • E.



    1. K2SO40.1mg/ml50ml0.10.5mgK2SO415ml

    2. 50ml2ml


    3.

    4.

    5.



    • D

      • A.

      • B.

      • C.

      • D.

  • E.


  • ChP2000USP24

    1.


    2.

    25ml50ml4ml50mg


    35m130%3ml50ml50ml


    25ml4ml50mg35m130%3ml50ml


    1FeNH4(SO4)212H2OFe3+10g Fe3+/ml50ml1050gFe3+1.05.0ml

    3.


    250ml4ml

    3

    4Fe2+Fe3+


    5Fe2+Fe3+Fe2+Fe3+

    Fe2+Fe3+


    6


    4.

    1

    2700800

    3


    BP1998


    • 1. 2000A

      • A.

      • B.

      • C.

      • D

      • E.


    2. 2000AB

    A. Fe3+

    B.

    C.

    D

    E


    • 3. E

      • A.

      • B.

      • C.

      • D. 600700

      • E.


    • 4. D

      • A. Fe

      • B. Fe2+

      • C. Fe3+

      • D. Fe2+Fe3+

  • E.


  • 2000


    1.


    2.

    1Pb2+10g Pb2+/ml27ml1020gPb2+


    22ml pH3.5pH33.5

    3ChP1990


    3.

    1

    A.

    B.

    C.


    2Fe3+0.51.0gFe3+Fe2+


    3Fe3+HFeCl KCN


    4ZnSO4KCNZn2+


    1.

    500600


    2.



    1.


    2.

    1NaOH

    2


    25g


    USP23


    • 9778pHB

      • A. 1.5

      • B. 3.5

      • C7.5

      • D. 9.5

      • E. 11.5


    • 9584C

      • A.

      • B.

      • C.

      • D.

      • E.


    • 1. (2000)BC

      • A.

      • B.

      • C.

      • D.

    • E.


    • 2. C

      • A.

      • B. 10ml/50ml

      • C. pH3.5

      • D.

      • E.


    3. C

    A.

    B.

    C.

    D.

    E.


    4. ACD

    A. 500600,

    B. pH33.5

    C.

    D.

    E.


    ChP2000BP1998


    1.

    HgBr22ml


    2.

    12ml

    2


    3.

    11gAs/ml

    25ml

    3


    A. As5+As3+

    B. I2I-I-Zn2+

    C.


    D. Sb100 gSb

    460mg6080mm

    5


    6

    4.

    1HNO3


    2Fe3+Fe2+

    3


    4SbSb100g


    Ag-DDC

    ChP(2000)USP24


    Ag-DDC

    AgDDC510nm


    HDDCUSP24ChP2000

    Sb500g


    ChP2000

    Sb


    BP1998


    • 9882. D

      • A.

      • B.

      • C.

      • D.

      • E.


    • 9779. C

      • A. I2

      • B. AsH3

      • C. H2S

      • D. HBr

      • E. SbH3


    • 99x75C

      • A.

      • B.

      • C.

      • D.

      • E.


    • 95140. SnC12ACD

      • A. As5+As3+

      • B. H2S

      • C. I2

      • D.

      • E.


    9583. AgDDCAgDDCE

    A.

    B.

    C.

    D.

    E.


    98137. 1995BE

    A. H2S

    B. AsH3

    C.

    D.

    E.


    96[106110]99x[126130]

    A. Gutzeit

    B.

    C. AB D. AB

    96106C

    961072m1C

    96108A

    96109B

    96110D


    [15]

    A.

    B.

    C. D.

    E.

    1. A

    2. A

    3. A

    4. B

    5. C


    6. AgDDCC

    A. HDDC

    B. Ag

    C. Ag

    D. Ag(DDC)

    E. AsAg3


    7. ChP2000B

    A.

    B.

    C.

    D. AgDDC

    E.


    8. BCDE

    APb2+

    BSnCl2

    CKI

    DZn

    E


    9. Ag-DDCABCDE

    AAs5+As3+

    BAsH3

    CSbH3

    DZn-Sn

    EAsH3


    10. C

    A. 1ml

    B. 5ml

    C. 2ml

    D.

    E.


    11. (B)

    A.

    B.

    C. 10ml/50ml

    D. 10ml/50ml

    E. ()


    • 96[96100]

      • A. 0.002mg B. 0.010.02mg

      • C. 0.010.05mg D. 0.050.08mg

      • E. 0.10.5mg

    • 9696. 50ml(E)

    • 9697. 50ml(C)

    • 9698. 35ml(B)

    • 9699. (A)

    • 96100. 50ml(D)


    • 97[106110]

      • A. B.

      • C. D.

      • E.

    • 97106E

    • 97107D

    • 97108B

    • 97109C

    • 97110A


    • 98[96100]

      • A. B. C.

      • D. E.

  • 9896D

  • 9897C

  • 9898E

  • 9899Ag-DDCB

  • 98100B


    • [15]

      • A. B. C.

      • D. E.

        • 1. A

        • 2. B

        • 3. B

        • 4. E

        • 5. D


    ChP(2000)





    H2SO4

    H2SO4


    1

    2


    3


    1.


    2.


    1.0010

    5


    3. 0.5

    4.


    ()

    1.

    + H2SO4700800

    0.1%0.2%


    2.


    3.

    1


    2

    3500600

    4


    1. C

    A. 500600

    B. 600700

    C. 700800

    D. 8001000

    E. 10001200


    2. A

    A. 500600

    B. 600700

    C. 700800

    D. 8001000

    E. 10001200


    • 3. E

      • A. 1

      • B. 0.51

      • C. 0.40.5

      • D. 0.20.3

      • E. 0.10.2


    4. C

    A.

    B.

    C.

    D.

    E.



    105

    1h


    .5h

    P2O5


    2.67kPa20mmHg


    [15]

    A B

    C D

    1. D

    2. D

    3. C

    4. (B)

    5. A


    6. BCDE

    A500600

    B

    C

    D

    E


    7. ABCD

    A. 5mm

    B. 105

    C.

    D.

    E. 3




    1. TGA

    (m)(T)(t)


    m



    2. DTA

    T()


    (T)T(CRCs)


    T



    3. DSC

    ()



    1.


    2.

    0.250.18mm


    80170


    11000

    21.5


    35510


    3.




    1.

    2.

    3.

    4.


    1.

    2.

    3.

    4.



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