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QC 2 LEC > M3L1 > Flashcards

M3L1 Flashcards

1
Q

is a process of MEASURING and ANALYZING the properties of drug products before, during and after the manufacturing process

A

DRUG PRODUCTS TESTING

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2
Q

COMPEDIAL REQUIREMENTS FOR SOLID DOSAGE FORMS

testing of Pharmaceutical product involves ____, ____, and some ____ evalutaion or tests

A

chemical, physical, and microbiological

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3
Q

according to WHO, ____ refers to the SUM of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product

A

QUALITY CONTROL

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4
Q

____ involves TESTING OF UNITS and determining if they are within the specifications for the final product

A

QUALITY CONTROL

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5
Q

the purpose of the testing is to determine any NEEDS for CORRECTIVE ACTIONS in the manufacturing process to uncover defects from the decisions whether to ALLOW or DENY product release

A

QUALITY CONTROL

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6
Q

PURPOSE of quality control

A

determine any needs for corrective actions
allow or deny product release

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7
Q

____ improves the OVERALL QUALITY of the drug and helps companies MEET CONSUMER DEMANDS for better product

A

GOOD QUALITY CONTROL

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8
Q

Quality control tests for TABLETS

6

A

weight variation
content uniformity
disintegration
dissolution
friability
hardness & thickness

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9
Q
  • is used to ensure that each tablet contains the PROPER AMOUNT of drug
  • involves the determination of individual weights of the samples tested and computation for the average weight
A

WEIGHT VARIATION

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10
Q

CRITERIA

WEIGHT VARIATION

A
  • NMT 2 tablets should differ by more than the % weight variation
  • NO TABLET differs by more than double the % weight variation

TWO CRITERIA MUST BE SATISFIED

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11
Q
  • it is intended to establish within limits that a product has UNIFORM AMOUNT of an active ingredient in a batch
  • it is done to determine UNIFORMITY in dosage units for samples whose active ingredient is LESS THAN 50mg
A

CONTENT UNIFORMITY TEST

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12
Q

CONTENT UNIFORMITY TEST is done to determine uniformity in dosage units for samples whose active ingredient is ____ (weight)

A

LESS than 50mg

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13
Q

CRITERIA

CONTENT UNIFORMITY TEST:
STAGE 1: 10 SAMPLES

A

85% - 115%
no sample excess the specifications

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14
Q

CRITERIA

CONTENT UNIFORMITY TEST:

A
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15
Q

CRITERIA

CONTENT UNIFORMITY TEST:
STAGE 1: 1 sample EXCEEDS the specification

A

75 - 125%
repeat the test with additional 20 samples

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16
Q

CRITERIA

CONTENT UNIFORMITY TEST:
STAGE 2: additional 20 samples

A

85 - 115%
NONE of the sample exceed out the specification

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17
Q
  • involves MECHANICAL BREAK UP of compressed tablet into smaller granules upon ingestion
  • a qualitative test that measures the TIME required, under a gicen set of conditions, for a group of solid dosage forms to disintegrate.
  • this test is conducted to determine whether tablets or capsules disintegrate within the prescribed time when places in a liquid medium under experimental conditions
A

DISINTEGRATION

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18
Q

a state in which any residue of the unit except fragments of insoluble coatings and capsule shells remaining on the screen of the test apparatus or adehring to the lower surface of the disk, if used, is a SOFT MASS HAVING NO PALPABLY FIRM CORE

A

COMPLETE DISINTERGRATION

19
Q

DISINTEGRATION APPARATUS A

  • 6 open-ended transparent tubes
  • 10-mesh wire cloth at the bottom
  • discs
  • 1000mL low form beaker
  • a thermostatic arrangement for heating the fluid
  • a device for RAISING and LOWERING the basket
A

BASKET-RACK ASSEMBLY

20
Q

DISINTEGRATION APPARATUS

BASKET RACK ASSEMBLY:
____ open-ended transparent tubes

21
Q

DISINTEGRATION APPARATUS

BASKET RACK ASSEMBLY:
____-mesh WIRE CLOTH at the bottom

22
Q

DISINTEGRATION APPARATUS

BASKET RACK ASSEMBLY:
____mL low form beaker

23
Q

DISINTEGRATION APPARATUS

  • composed of 3 open-ended tubes
  • used for testing LARGE tablets and capsules, usually for VETERINARY USE
  • use of sinkers – only when specified in the monograph
A

APPARATUS B

24
Q

DISINTEGRATION APPARATUS

APPARATUS B:
composed of ____ open-ended tubes

25
Q

DISINTEGRATION APPARATUS

APPARATUS B:
used for testing ____ tablets and capsules

A

LARGE

usually for VETERINARY USE

26
Q

DISINTEGRATION APPARATUS MEDIA

all are maintaned at a temperature of ____

27
Q

DISINTEGRATION APPARATUS MEDIA

A

Distilled Water
Stimulated Gastric Fluid TS
Stimulated Intestinal Fluid TS

28
Q

DISINTEGRATION APPARATUS MEDIA

STIMULATED GASTRIC FLUID TS

A

NaCl
PEPSIN
HCl

29
Q

DISINTEGRATION APPARATUS MEDIA

pH:
STIMULATED GASTRIC FLUID TS

30
Q

DISINTEGRATION APPARATUS MEDIA

STIMULATED INTESTINAL FLUID TS

A

monobasic potassium phosphate
NaOH
PANCREATIN

31
Q

DISINTEGRATION APPARATUS MEDIA

pH:
STIMULATED INTESTINAL FLUID TS

32
Q

DURATION OF TESTING

UNCOATED tablets

33
Q

DURATION OF TESTING

FILM coated tablets

34
Q

DURATION OF TESTING

BUCCAL tablets

35
Q

DURATION OF TESTING

SUGAR coated tablets

36
Q

DURATION OF TESTING

ENTERIC coated tablets

A

60mins in phosphate buffer (pH 6.8)

37
Q

DURATION OF TESTING

DISPERSIBLE / SOLUBLE tablets

38
Q

DURATION OF TESTING

EFFERVESCENT tablets

39
Q

DURATION OF TESTING

HARD GELATIN capsules

40
Q

DURATION OF TESTING

ENTERIC capsules

A

60mins in phosphate buffer (pH 6.8)

41
Q

pH:
PHOSPHATE BUFFER

42
Q

DURATION OF TESTING

SOFT GELATIN capsules

QC 2 LEC (7 decks)

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