This presentation is the property of its rightful owner.
Sponsored Links
1 / 167

第二章 药物的杂质检查 PowerPoint PPT Presentation


  • 65 Views
  • Uploaded on
  • Presentation posted in: General

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.

Download Presentation

第二章 药物的杂质检查

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


3552845


3552845


3552845

forinimpurities

1.

2.

3.


3552845

1

2

1.

3


3552845

96131

A.

B.

C.

D.

E.


3552845

2.


3552845


3552845

1.


3552845

2.


3552845

99x851995

A.

B.

C.

D.

E.


3552845

GRARCP


3552845

  • .

    • A.

    • B.

    • C.

    • D.

    • E.


3552845

ppm


3552845


3552845

1.

Limit Test


3552845

2.


3552845

3.

pH


3552845


3552845

97712ml1ml1gAs0.0001

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

D. 1.0g E. 0.10g


3552845

c1 g/ml1106 g/ml

V2ml L0.0001%


3552845

9679C1.0g1ml0.01mgPbml

A. 0.2ml B. 0.4ml C2ml

D. 1ml E. 20ml


3552845

1.


3552845

1 2mm

2


3552845

2. 1g2%1g1%

3.

4.


3552845


3552845

25ml10m150ml


3552845

40m1

50ml10m140m1


3552845

1.0m150m15


3552845

1. NaCl 10gCl/ml50ml5080gClNaCl58ml

2. 50ml10ml


3552845

1AgCl

2

3


3552845

3.

4.

5. 5


3552845

6.

7.


3552845

1.

1

2


3552845

2.

1

2

3


3552845

3.

1

2

3


3552845

4.


3552845

  • 9582. B

    • A. B.

    • C. D.

    • E.


3552845

  • 1. 2000 10gCl/ml58mlD

    • A.

    • B.

    • C.

    • D.

    • E.


3552845

  • 2. ABCDE

    • A

    • B

    • C

    • D

    • E


3552845

  • 3. AB

    • A

    • B

    • C

    • D

  • E


  • 3552845

    • 4. D

      • A.

      • B.

      • C.

      • D.

      • E.


    3552845

    • 5. ABC

      • A.

      • B. (10ml/50ml)

      • C. 5

      • D.

      • E.


    3552845


    3552845

    1. K2SO40.1mg/ml50ml0.10.5mgK2SO415ml

    2. 50ml2ml


    3552845

    3.

    4.

    5.


    3552845


    3552845

    • D

      • A.

      • B.

      • C.

      • D.

  • E.


  • 3552845

    ChP2000USP24

    1.


    3552845

    2.

    25ml50ml4ml50mg


    3552845

    35m130%3ml50ml50ml


    3552845

    25ml4ml50mg35m130%3ml50ml


    3552845

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

    3.


    3552845

    250ml4ml

    3

    4Fe2+Fe3+


    3552845

    5Fe2+Fe3+Fe2+Fe3+

    Fe2+Fe3+


    3552845

    6


    3552845

    4.

    1

    2700800

    3


    3552845

    BP1998


    3552845

    • 1. 2000A

      • A.

      • B.

      • C.

      • D

      • E.


    3552845

    2. 2000AB

    A. Fe3+

    B.

    C.

    D

    E


    3552845

    • 3. E

      • A.

      • B.

      • C.

      • D. 600700

      • E.


    3552845

    • 4. D

      • A. Fe

      • B. Fe2+

      • C. Fe3+

      • D. Fe2+Fe3+

  • E.


  • 3552845

    2000


    3552845

    1.


    3552845

    2.

    1Pb2+10g Pb2+/ml27ml1020gPb2+


    3552845

    22ml pH3.5pH33.5

    3ChP1990


    3552845

    3.

    1

    A.

    B.

    C.


    3552845

    2Fe3+0.51.0gFe3+Fe2+


    3552845

    3Fe3+HFeCl KCN


    3552845

    4ZnSO4KCNZn2+


    3552845

    1.

    500600


    3552845

    2.


    3552845


    3552845

    1.


    3552845

    2.

    1NaOH

    2


    3552845

    25g


    3552845

    USP23


    3552845

    • 9778pHB

      • A. 1.5

      • B. 3.5

      • C7.5

      • D. 9.5

      • E. 11.5


    3552845

    • 9584C

      • A.

      • B.

      • C.

      • D.

      • E.


    3552845

    • 1. (2000)BC

      • A.

      • B.

      • C.

      • D.

    • E.


    3552845

    • 2. C

      • A.

      • B. 10ml/50ml

      • C. pH3.5

      • D.

      • E.


    3552845

    3. C

    A.

    B.

    C.

    D.

    E.


    3552845

    4. ACD

    A. 500600,

    B. pH33.5

    C.

    D.

    E.


    3552845

    ChP2000BP1998


    3552845

    1.

    HgBr22ml


    3552845

    2.

    12ml

    2


    3552845

    3.

    11gAs/ml

    25ml

    3


    3552845

    A. As5+As3+

    B. I2I-I-Zn2+

    C.


    3552845

    D. Sb100 gSb

    460mg6080mm

    5


    3552845

    6

    4.

    1HNO3


    3552845

    2Fe3+Fe2+

    3


    3552845

    4SbSb100g


    3552845

    Ag-DDC

    ChP(2000)USP24


    3552845

    Ag-DDC

    AgDDC510nm


    3552845

    HDDCUSP24ChP2000

    Sb500g


    3552845

    ChP2000

    Sb


    3552845

    BP1998


    3552845

    • 9882. D

      • A.

      • B.

      • C.

      • D.

      • E.


    3552845

    • 9779. C

      • A. I2

      • B. AsH3

      • C. H2S

      • D. HBr

      • E. SbH3


    3552845

    • 99x75C

      • A.

      • B.

      • C.

      • D.

      • E.


    3552845

    • 95140. SnC12ACD

      • A. As5+As3+

      • B. H2S

      • C. I2

      • D.

      • E.


    3552845

    9583. AgDDCAgDDCE

    A.

    B.

    C.

    D.

    E.


    3552845

    98137. 1995BE

    A. H2S

    B. AsH3

    C.

    D.

    E.


    3552845

    96[106110]99x[126130]

    A. Gutzeit

    B.

    C. AB D. AB

    96106C

    961072m1C

    96108A

    96109B

    96110D


    3552845

    [15]

    A.

    B.

    C. D.

    E.

    1. A

    2. A

    3. A

    4. B

    5. C


    3552845

    6. AgDDCC

    A. HDDC

    B. Ag

    C. Ag

    D. Ag(DDC)

    E. AsAg3


    3552845

    7. ChP2000B

    A.

    B.

    C.

    D. AgDDC

    E.


    3552845

    8. BCDE

    APb2+

    BSnCl2

    CKI

    DZn

    E


    3552845

    9. Ag-DDCABCDE

    AAs5+As3+

    BAsH3

    CSbH3

    DZn-Sn

    EAsH3


    3552845

    10. C

    A. 1ml

    B. 5ml

    C. 2ml

    D.

    E.


    3552845

    11. (B)

    A.

    B.

    C. 10ml/50ml

    D. 10ml/50ml

    E. ()


    3552845

    • 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)


    3552845

    • 97[106110]

      • A. B.

      • C. D.

      • E.

    • 97106E

    • 97107D

    • 97108B

    • 97109C

    • 97110A


    3552845

    • 98[96100]

      • A. B. C.

      • D. E.

  • 9896D

  • 9897C

  • 9898E

  • 9899Ag-DDCB

  • 98100B


  • 3552845

    • [15]

      • A. B. C.

      • D. E.

        • 1. A

        • 2. B

        • 3. B

        • 4. E

        • 5. D


    3552845

    ChP(2000)


    3552845


    3552845


    3552845


    3552845

    H2SO4

    H2SO4


    3552845

    1

    2


    3552845

    3


    3552845

    1.


    3552845

    2.


    3552845

    1.0010

    5


    3552845

    3. 0.5

    4.


    3552845

    ()

    1.

    + H2SO4700800

    0.1%0.2%


    3552845

    2.


    3552845

    3.

    1


    3552845

    2

    3500600

    4


    3552845

    1. C

    A. 500600

    B. 600700

    C. 700800

    D. 8001000

    E. 10001200


    3552845

    2. A

    A. 500600

    B. 600700

    C. 700800

    D. 8001000

    E. 10001200


    3552845

    • 3. E

      • A. 1

      • B. 0.51

      • C. 0.40.5

      • D. 0.20.3

      • E. 0.10.2


    3552845

    4. C

    A.

    B.

    C.

    D.

    E.


    3552845


    3552845

    105

    1h


    3552845

    .5h

    P2O5


    3552845

    2.67kPa20mmHg


    3552845

    [15]

    A B

    C D

    1. D

    2. D

    3. C

    4. (B)

    5. A


    3552845

    6. BCDE

    A500600

    B

    C

    D

    E


    3552845

    7. ABCD

    A. 5mm

    B. 105

    C.

    D.

    E. 3


    3552845


    3552845


    3552845

    1. TGA

    (m)(T)(t)


    3552845

    m


    3552845


    3552845

    2. DTA

    T()


    3552845

    (T)T(CRCs)


    3552845

    T


    3552845


    3552845

    3. DSC

    ()


    3552845


    3552845

    1.


    3552845

    2.

    0.250.18mm


    3552845

    80170


    3552845

    11000

    21.5


    3552845

    35510


    3552845

    3.


    3552845


    3552845


    3552845

    1.

    2.

    3.

    4.


    3552845

    1.

    2.

    3.

    4.


    3552845


  • Login