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QC 1 (LEC) > CHAPTER 2- Methods of Analysis in Quantitative Pharmaceutical Chemistry > Flashcards

CHAPTER 2- Methods of Analysis in Quantitative Pharmaceutical Chemistry Flashcards

1
Q

The determination of the VOLUME OF SOLUTION of known concentration required to react with a given amount of the substance to be analyzed

A

Volumetric Analysis

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2
Q
  • Based on some specific physical or chemical property/ properties of the substance being analyzed
  • involve instrumental techniques such as chromatography, spectrophotometry, refractometry, polarimetry
A

Physicochemical Methods

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3
Q

The separation by extraction, precipitation, or other means of the constituent to be determined either in the natural state or in the
form of a definite compound the composition of which is known to the analyst, and the weighing of the resulting product

A

Gravimetric Analysis

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4
Q
  • Those which require a distinct type of technique such as alkaloidal assaying
A

Special Method

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5
Q
  • Done simultaneously
A

Replicates

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6
Q
  • Done at different time
A

Trials

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7
Q

9 Grades of Chemicals

A
  1. Reagent ACS
  2. Guaranteed Reagent (GR)
  3. Analytical Reagent (AR) Grade
  4. Primary Standard
  5. Purified
  6. Lab Grade
  7. USP Grade
  8. NF Grade
  9. Technical Grade
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8
Q

High quality chemical for laboratory use (American Chemical Society)

A

Reagent ASC

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9
Q

Suitable for use in analytical chemistry, products meet or exceed ACS requirement

A

Guaranteed Reagent (GR)

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10
Q

More or less similar to ACS

A

Analytical Reagent (AR) Grade

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11
Q

For titration

A

Primary Standard

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12
Q

Chemicals of good quality where there are no official standards; usually limited to inorganic chemicals.

A

Purified

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13
Q

A line of solvents suitable for histology methods and general laboratory application

A

Lab Grade

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14
Q

Chemicals manufactured under CGMP and meet requirements of USP

A

USP Grade

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15
Q

National Formulary

A

NF Grade

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16
Q

Suitable for general industrial use

A

Technical Grade

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17
Q

Undesirable characteristics of a product

A

Defects

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18
Q

3 Types of Defects

A
  1. According to measurability
  2. According to Seriousness/Gravity
  3. According to Nature
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19
Q

(2) According to measurability

A
  1. Attribute Defect
  2. Variable Defect
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20
Q

According to measurability
- Cannot be measured by any instrument (ex:
odor, cleanliness)

A

Attribute Defect

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21
Q

According to measurability
- measured by instruments (ex: weight,
thickness)

A

Variable Defect

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22
Q

(3) According to Seriousness/Gravity

A
  1. Critical Defect
  2. Major Defect
  3. Minor Defect
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23
Q

According to Seriousness/Gravity
- Endanger life or property, may render product nonfunctional
(ex: disintegration time)

A

Critical Defect

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24
Q

According to Seriousness/Gravity
- May render product useless
(ex: cracked bottle)

A

Major Defect

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25
Q

According to Seriousness/Gravity
- does not endanger life nor affect function
(ex: label)

A

Minor Defect

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26
Q

(3) According to Nature

A
  1. Ocular Defect
  2. Internal Defect
  3. Performance Defect
27
Q

According to Nature
- visible (foreign particulate)
- can be seen in the naked eye

A

Ocular Defect

28
Q

According to Nature
- not seen (subpotent)

A

Internal Defect

29
Q

According to Nature
- a defect in function
(ex: suppository that does not melt in body temperature)

A

Performance Defect

30
Q

4 Sources of Variation (4M’s)

A
  1. Material
  2. Machine
  3. Method
  4. Men
31
Q
  • Examine raw materials received
  • Conduct physical test for packaging materials
A

Materials Inspection Section

32
Q
  • Performs physical and chemical analysis
A

Analytical Laboratory

33
Q

-Performs microbiological, pharmacological, strerility and toxicity tests
- Conducts environmental monitoring

A

Biological Testing Laboratory

34
Q
  • Airborne Particulate Cleanliness Classes in Cleanrooms and Clean zones
  • Are maintained in areas of parenteral manufacturing
A

Parenterals - Class 100

35
Q
  • Research development
  • Validate procedures
  • Develop new assays
  • Develop and improve final product
A

Analytical Development/ Research & Development

36
Q
  • Maintain records
  • Investigate complaints
  • Maintain and develop SOP
A

Quality Coordination Office

37
Q

4 Control Functions

A
  1. Analysis Function
  2. Monitoring Function
  3. Record, Review and Release Function
  4. Audit Function
37
Q

Control Function
- To assure acceptability of product
- All materials are within specifications

A

Analysis Function

38
Q

Control Function
- In process testing
- Any deviation must be reported
- Environmental monitoring

A

Monitoring Function

39
Q

Control Function
- Batch Record; all records during course of producing quality controlled product

A

Record, Review and Release Function

40
Q

Control Function
- Audit Function

A

Audit Function

41
Q

Secure a representative samples; sampled from
different parts

A

Sampling

42
Q

Finite number of objects selected from a given population

A

Sample

43
Q

3 Inspection Methods

A
  1. Single Sampling
  2. Double Sampling
  3. Triple Sampling
44
Q

A decision is reached after one sampling

A

Single Sampling

45
Q

To avoid mix-ups

A

Sticker

46
Q

Yellow

A

Quarantine

47
Q

Red

A

Rejected

48
Q

Green

A

Approved

49
Q

(2) Printed & Packaging Materials

A
  1. Primary Packaging Components
  2. Secondary Packaging
50
Q

Direct contact with the product
Ex: Caps, capsules, bottles

A

Primary Packaging Components

51
Q

Do not come in direct contact
Ex: Labels, inserts and cartons

A

Secondary Packaging Components

52
Q
  • The date of retest is known as re-assay date
  • Monthly or prior to use - highly unstable
    materials
A

Re- assay Dates

53
Q

6 months - Vitamins, Flavors
12 months - Dyes
24 months - Excipients

A

Re- assay Dates

54
Q

Means specific amount produced in a unit time or according to a single manufacturing order during same cycle of manufacture

A

Batch

55
Q

A batch; or portion of a batch

A

Lot

56
Q

_____ and ______ are witheld from distribution until BATCH CERTIFICATE from FDA is received

A

Antibiotic and Insulin

57
Q

2 QC Charts

A
  1. Variable Chart
  2. Attribute Chart
58
Q
  • Use actual records of numerical measurement on a full continuous scale such as meter, grams, liter
    Ex: mean and R charts
A

Variable Chart

59
Q
  • Makes use of discrete data classifying the number of items conforming and falling
    Ex: P chart (control chart for
    fraction defective)
A

Attribute Chart

60
Q

Control Chart consists of:

A
  1. Control Solid Line
  2. Upper Control Limit (UCL)
  3. Lower Control Unit (LCL)
61
Q
  • Average
  • 2 horizontal parallel lines on either sides of the solid line which indicate limits
A

Control Solid Line

62
Q
  • Normally 3 standard deviation above the centerline
  • UCL = Mean + 3 (SD)
A

Upper Control Limit (UCL)

63
Q
  • Standard deviation below the center line
  • LCL = Mean - 3 (SD)
A

Lower Control Unit (LCL)

QC 1 (LEC) (6 decks)

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