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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
According to Seriousness/Gravity - does not endanger life nor affect function (ex: label)
Minor Defect
26
(3) According to Nature
1. Ocular Defect 2. Internal Defect 3. Performance Defect
27
According to Nature - visible (foreign particulate) - can be seen in the naked eye
Ocular Defect
28
According to Nature - not seen (subpotent)
Internal Defect
29
According to Nature - a defect in function (ex: suppository that does not melt in body temperature)
Performance Defect
30
4 Sources of Variation (4M's)
1. Material 2. Machine 3. Method 4. Men
31
- Examine raw materials received - Conduct physical test for packaging materials
Materials Inspection Section
32
- Performs physical and chemical analysis
Analytical Laboratory
33
-Performs microbiological, pharmacological, strerility and toxicity tests - Conducts environmental monitoring
Biological Testing Laboratory
34
- Airborne Particulate Cleanliness Classes in Cleanrooms and Clean zones - Are maintained in areas of parenteral manufacturing
Parenterals - Class 100
35
- Research development - Validate procedures - Develop new assays - Develop and improve final product
Analytical Development/ Research & Development
36
- Maintain records - Investigate complaints - Maintain and develop SOP
Quality Coordination Office
37
4 Control Functions
1. Analysis Function 2. Monitoring Function 3. Record, Review and Release Function 4. Audit Function
37
Control Function - To assure acceptability of product - All materials are within specifications
Analysis Function
38
Control Function - In process testing - Any deviation must be reported - Environmental monitoring
Monitoring Function
39
Control Function - Batch Record; all records during course of producing quality controlled product
Record, Review and Release Function
40
Control Function - Audit Function
Audit Function
41
Secure a representative samples; sampled from different parts
Sampling
42
Finite number of objects selected from a given population
Sample
43
3 Inspection Methods
1. Single Sampling 2. Double Sampling 3. Triple Sampling
44
A decision is reached after one sampling
Single Sampling
45
To avoid mix-ups
Sticker
46
Yellow
Quarantine
47
Red
Rejected
48
Green
Approved
49
(2) Printed & Packaging Materials
1. Primary Packaging Components 2. Secondary Packaging
50
Direct contact with the product Ex: Caps, capsules, bottles
Primary Packaging Components
51
Do not come in direct contact Ex: Labels, inserts and cartons
Secondary Packaging Components
52
- The date of retest is known as re-assay date - Monthly or prior to use - highly unstable materials
Re- assay Dates
53
6 months - Vitamins, Flavors 12 months - Dyes 24 months - Excipients
Re- assay Dates
54
Means specific amount produced in a unit time or according to a single manufacturing order during same cycle of manufacture
Batch
55
A batch; or portion of a batch
Lot
56
_____ and ______ are witheld from distribution until BATCH CERTIFICATE from FDA is received
Antibiotic and Insulin
57
2 QC Charts
1. Variable Chart 2. Attribute Chart
58
- Use actual records of numerical measurement on a full continuous scale such as meter, grams, liter Ex: mean and R charts
Variable Chart
59
- Makes use of discrete data classifying the number of items conforming and falling Ex: P chart (control chart for fraction defective)
Attribute Chart
60
Control Chart consists of:
1. Control Solid Line 2. Upper Control Limit (UCL) 3. Lower Control Unit (LCL)
61
- Average - 2 horizontal parallel lines on either sides of the solid line which indicate limits
Control Solid Line
62
- Normally 3 standard deviation above the centerline - UCL = Mean + 3 (SD)
Upper Control Limit (UCL)
63
- Standard deviation below the center line - LCL = Mean - 3 (SD)
Lower Control Unit (LCL)

QC 1 (LEC) (6 decks)

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