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PR3154 > IC12 - QA and Pharmacopeial Assay > Flashcards

IC12 - QA and Pharmacopeial Assay Flashcards

1
Q

What are the 5 key components of GMP?

A
  1. Pure starting materials
  2. Well maintained premises and equipment
  3. Competent personnel to operate processes
  4. Use of up-to-date technology
  5. Processes are documented
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2
Q

Who overlooks the quality for medicine?

A

International conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ICH)

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3
Q

ICH standardizes the validation of analytical procedures and indicates that validation is required for _______.

A
  1. Identification tests
  2. Quantitative tests for impurities
  3. Limits tests for impurities control
  4. Quantitative tests of API, drug products and selected components in the drug product
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4
Q

What are the 5 sources of impurities?

A
  1. Raw materials
  2. Manufacturing method
  3. Manufacturing Hazards
  4. Inadequate storage
  5. Atmospheric contaminants
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5
Q

What are the components in manufacturing methods that can cause impurities?

A
  1. Reagents employed in process
  2. Reagents added to remove other impurities
  3. Solvents
  4. Reaction vessels
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6
Q

What are the components in manufacturing hazards that can cause impurities?

A
  1. Particulate contamination
  2. Process errors
  3. Cross contamination
  4. Microbial contaminations
  5. Packing errors
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7
Q

What are the components in inadequate storage that can cause impurities?

A
  1. Filth
  2. Chemical instability
  3. Reaction with container materials
  4. Physical changes
  5. Temperature effects
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8
Q

Limit tests are _____ or ______.

A

Quantitative, Semi-quantitative

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9
Q

What is the purpose of limit tests?

A

Identify and control small quantities of impurity which may present in the drug substance

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10
Q

How is comparison method for limit tests done?

A

Compares test solution to standard solution containing a definite amount of impurity under the same time and condition.

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11
Q

What is the comparison test used for?

A

It is to determine amount of chlorides, sulfates, iron, and heavy metals

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12
Q

Name 3 types of identification tests.

A
  1. Infrared absorption
  2. Ultraviolet absorption
  3. Thin layer chromatography
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13
Q

What does the IR absorption tests for?

A

Stretching and bending of bonds in different functional groups of an analyte

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14
Q

What is the wavenumber of the fingerprint region of the IR spectrum?

A

600-1400 cm^-1

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15
Q

What is the use of a UV absorption test?

A

Determine absorptivity and/or absorbance ratio

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16
Q

When are the requirements of test sample in UV absorption test when compared to standard solution spectra?

A
  1. Maxima and minima at the same wavelength
  2. Absorptivities and/or absorbance ratios are within specified limits
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17
Q

How is the positive identity of test solution to that of standard reference determined in TLC?

A

Corresponding Rf value

18
Q

The 3 identification test are not _______ of each other.

A

independent

19
Q

What is the underlying principle of titrimetric analysis?

A

Chemically reacting an amount of known concentration standard reagent with an analyte such that the amount of the standard reagent used is used to estimate the purity of the analyte.

20
Q

What are the applications of titrimetric analysis for pharmaceuticals?

A
  1. Determine purity of API in dosage form
  2. Purity of raw material for medicinal product preparation
21
Q

List 3 advantages of titrimetric analysis.

A
  1. High degree of precision and accuracy
  2. Robust methods
  3. Can automate process and cheap to do
22
Q

List 3 limitations of the titrimetric analysis for pharmaceuticals.

A
  1. Method may not be selective
  2. Time consuming
  3. Large amount of sample and reagents
23
Q

What are primary standards?

A

Stable chemical and high purity compounds used for standardizing of standard solutions used in titrations

24
Q

What is the purpose of primary standards?

A

Determine correction factor

25
Q

What is used to standardize sodium hydroxide solution and acetous perchloric acid?

A

Potassium hydrogen phthalate

26
Q

What is used to standardize sodium thiosulfate solution?

A

Potassium iodate

27
Q

What is used to standardize HCl?

A

Anhydrous sodium carbonate

28
Q

What is used to standardize EDTA solution?

A

Zinc

29
Q

What is the correction factor used for?

A

To simplify calculations to allow use to know how much a given solution differs from nominal concentration

30
Q

How is the correction factor calculated?

A

Ratio of actual concentration divided by desired/nominal concentration

31
Q

What is indirect titration?

A

Addition of excess standard to weighed amount of analyte, followed by determination of excess unreacted standard.

32
Q

What is indirect titration used for?

A
  1. Volatile substance
  2. Insoluble substance
  3. Substance for which a quantitative reaction which proceed rapidly only in excess reagent
  4. Substance which require heating with with volumetric reagent
33
Q

Why is blank titration required for indirect titration?

A

Heating and cooling may cause apparent changes in strength. Having a blank titration will standardize conditions.

34
Q

When is argentometric titration used?

A

For volumetric determination provided complete precipitation can be determined.

35
Q

What are the 3 types of HPLC analyses?

A
  1. Calibration with external standard
  2. Single point calibration
  3. Calibration against internal standard
36
Q

What is a limitation of single point calibration?

A

Concentration prepared may fall outside calibration curve.

37
Q

How can the limitation of single point calibration be overcome?

A

Use concentration that is similar to standard

38
Q

List 4 requirements of internal standard.

A
  1. Closely related in structure to analyte
  2. Stable
  3. Chromatographically resolved from analyte and any excipients
  4. Elute close to analytes
39
Q

When is external calibration often used?

A
  1. Determination of API or dosage form in assay
  2. Clean experiment (e.g. little components)
40
Q

When is internal standard used?

A
  1. Biological fluid analysis or where system is complex
41
Q

Why is internal standard important in cleaning of matrix?

A

Determines the recoverability of internal standard. If internal standard is highly recovered, analyte will behave similarly.

PR3154 (16 decks)

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