PHARM 17 | Laboratory Finals | By: Wai

Pharmaceutical QC 2
ACTIVITY NO. 01 (LABORATORY): WEIGHT VARIATION
Intended Learning Outcomes Materials/Equipment
By the end of this activity, you must be able to: • Weighing balance
1. Test the variability of the weights of capsules and tablets • Forceps
having the same lot number.
• Weighing container
2. Compare with pharmacopeial standards/specifications.
• Mefenamic acid 500 mg capsule
3. Review the importance of weight variation as a quality
control test in drug production. • Sodium bicarbonate 325 mg tablet

Actual Experimentation and Problem Solving Procedure/Instruction

• Weight variation is part of pharmaceutical analysis A. CAPSULE

procedures used to measure product quality. 1. Weigh 20 intact capsules individually and record each
• The quality of each drug may differ from the standard weight.
requirement. 2. Add the weight of all capsules and compute the average.
• Using this analysis, simple deviations can be easily Limits for Capsules (Pharmacopeial Standards):
detected.
• Less than 300 mg → ±10%
• Quality control is an integral part of all modern industrial
processes. • 300 mg or more → ±7.5%
Acceptance Criteria:
Factors Causing Weight Variation:
• No more than 2 capsules may deviate from the average
• Incorrect weighing and transfer of materials and excipients
weight by more than the % deviation.
• Incorrect use of pipettes, burettes (volumetric errors)
• None should deviate by more than double the percentage.
• Improper calibration of instruments
• Degraded assay conditions
B. UNCOATED TABLETS • Aligns with regulatory authority standards (e.g., FDA).
1. Weigh 20 whole uncoated tablets individually. • Enables manufacturers to withhold and test faulty batches
before release.
2. Add all weights and determine average weight.
2. What is the impact of varying weights on product quality?
Limits according to U.S.P:
• Varying weights compromise drug quality and safety.
• Less than 130 mg → ±10%
• Risks non-compliance with standards and loss of patient
• 130 mg – 324 mg → ±7.5%
trust.
• More than 324 mg → ±5%
• May lead to ineffective treatment or harmful dosing.
To Compute for Limit:
• Emphasizes the importance of regulatory testing and
• Upper limit = average weight + (average weight × % error) quality assurance.

• Lower limit = average weight - (average weight × % error) 3. What are the internal and external factors that affect weight?

Acceptance Criteria: Internal Factors:

• No more than 2 tablets should deviate beyond the % error. • Powder Density Variations → inconsistent dosing
• None should deviate more than twice the allowable • Particle Size Distribution → uneven particles cause
percentage. segregation
• Flowability of Powder → poor flow = incomplete filling =
weight variation
Guide Questions and Answers
🌡 External Factors:
1. What is the importance of Weight Variation in Quality
Control? • Environmental Conditions (humidity, temperature) → affect
powder’s moisture & flow
• Ensures safety and uniformity of pharmaceutical products.
• Equipment Issues → uncalibrated/damaged tools cause
• Confirms each dose contains accurate and consistent
dosing inconsistencies
amount of the active ingredient.
• Prevents underdosing or overdosing—critical to patient
safety.
ACTIVITY NO. 02 (LABORATORY): TESTING TABLET 3. Weigh tablet sample accurately.
FRIABILITY, THICKNESS AND HARDNESS
4. Place tablets in the drum and rotate:
o 100 times at 25 rpm for 4 minutes.
Intended Learning Outcomes
5. Remove, dedust, and reweigh tablets.
By the end of this activity, you must be able to: 6. Evaluation:
1. Test the friability of the formulated tablet using the o Fail the test if any tablets are cracked, cleaved, or
friabilator. broken after tumbling.
2. Determine the weight loss of the tablets during the test. o If weight loss is excessive or unclear, repeat test
3. Evaluate compliance with the USP limits for friability. twice.
o Acceptable limit:
Mean weight loss ≤ 1.0% across three tests.
Materials/Equipment
o Equipment variants: Drums with dual scooping
• Friability Tester projections or multiple drums may be used.
• Hardness Tester
• Vernier Caliper B. THICKNESS TEST
• Formulated Tablet • Use a Vernier Caliper to measure the thickness of 10
tablets.

Procedure/Instructions • Tabulate the results.

A. FRIABILITY TEST
1. Tablet sample size: C. HARDNESS TEST

o If ≤ 650 mg, take a sample close to 6.5 g. • Use a Monsanto Tablet Hardness Tester.

o If > 650 mg, use 10 whole tablets. • Measure and record tablet hardness.

2. Dedust tablets before testing. • Express results in different hardness units.

Guide Questions and Answers 5. Why is uniform thickness important?
• Ensures:
1. What does the friability test measure?
• It assesses the mechanical strength of tablets and their o Consistent dosage
resistance to breaking or crumbling during handling,
packaging, and transport. o Aesthetic quality

2. What is the acceptable limit for % weight loss in friability test o Even drug distribution
(USP)? 6. What do thickness variations indicate?
• Not more than 1.0% • Manufacturing issues, such as:
3. Causes of excessive friability: o Inconsistent die fill
• Inadequate binder concentration o Uneven pressure during compression
• Over-drying of granules o May affect quality, functionality, and appearance
• Over-lubrication 7. Principle behind hardness test:
• Improper tablet design • Measures the force required to break a tablet to determine
• Insufficient compression force its stress resistance and structural integrity.

• Use of certain excipients (e.g., microcrystalline cellulose) 8. Units used to measure tablet hardness:

4. How is tablet thickness measured? • Kilogram-force (kgf)

• Using: • Newton (N)

o Vernier Caliper (most common) • Pound-force (lbf)

o Micrometer • Kilopond (kp)

o Thickness Gauge • Strong-Cobb (SC) (older unit)

• To measure: Place tablet between jaws and read scale 9. Acceptable hardness range for uncoated tablets:
(manual or digital). • 4 to 10 kg
10. Importance of tablet hardness: Definitions:
• Ensures tablets can withstand: Term Definition Key Function / Use
o Manufacturing stress
A device that tests the Measures weight
Friability
o Packaging mechanical strength of tablets loss due to chipping
Tester
by simulating handling stress. or abrasion.
o Transport
• Influences: Hardness An instrument that measures the Determines tablet
Tester force required to break a tablet. crushing strength.
o Disintegration
A precision measuring tool with
o Dissolution rate Measures tablet
a main and vernier scale for
Vernier Caliper thickness or
o Drug release and bioavailability accurate dimensional
diameter in mm.
measurements.

A compressed solid dosage form Provides precise

Summary of Acceptable Limits (USP) Formulated
containing active ingredients dosing and
Tablet
Test Acceptable Limit and excipients. controlled release.

Friability ≤ 1.0% weight loss

Hardness 4–10 kg (for uncoated)

Thickness Must be uniform and consistent

MULTIPLE CHOICE QUESTIONS 5. If a tablet weighs more than 324 mg, what is the allowed %
error?
Choose the best answer for each item.
A. ±5%
ACTIVITY 01: Weight Variation (Items 1–25) B. ±7.5%
C. ±10%
1. What is the primary purpose of the weight variation test? D. ±12.5%
A. To measure friability
B. To test tablet flavor 6. Which equipment is not required for the weight variation test?
C. To assess dosage uniformity A. Forceps
D. To calculate tablet thickness B. Hardness tester
C. Weighing balance
2. How many capsules or tablets are used in the weight variation D. Weighing container
test?
A. 10 7. How do you calculate the average weight of tablets?
B. 15 A. Total weight ÷ 10
C. 20 B. Total weight ÷ 20
D. 25 C. Total weight ÷ 5
D. Total weight ÷ number of broken tablets
3. What is the percentage deviation limit for capsules weighing
less than 300 mg? 8. What is the purpose of comparing individual weights with
A. 5% upper and lower limits?
B. 7.5% A. To identify excipients
C. 10% B. To confirm packaging standards
D. 15% C. To assess uniformity
D. To ensure dissolution
4. What pharmacopeia standard is followed for the tablet weight
variation test? 9. Which of the following is an internal factor affecting weight
A. JP variation?
B. BP A. Humidity
C. USP B. Temperature
D. IP C. Powder density variation
D. Equipment calibration
10. One factor that could lead to incorrect weights is: C. Causes segregation
A. Over-coating D. Affects color
B. Inaccurate pipette use
16. What does the term flowability affect in tablet manufacturing?
C. Proper storage
A. Tablet coating
D. Extended shelf-life
B. Filling consistency
11. A capsule weighing 500 mg must follow what percentage C. Hardness
deviation limit? D. pH
A. 5%
17. External factors affecting weight variation include:
B. 7.5%
A. Flow properties
C. 10%
B. Particle size
D. 12.5%
C. Humidity and temperature
12. What should be done if a batch fails weight variation testing? D. Compression speed
A. Distribute immediately
18. Poor powder density control can cause:
B. Adjust the packaging
A. Consistent dose
C. Retest or reject the batch
B. Uniform hardness
D. Add more active ingredient
C. Irregular weight
13. Which of the following is a reason why weight variation is D. Faster dissolution
important?
19. Regulatory bodies like FDA require weight variation tests to:
A. To increase tablet shelf life
A. Enhance packaging
B. To ensure correct dosage
B. Assure efficacy and safety
C. To improve tablet taste
C. Add flavors
D. To reduce cost
D. Promote branding
14. Which capsule is considered non-compliant?
20. A drug failing weight variation tests poses risk of:
A. One that deviates by 1%
A. Allergies
B. One that deviates twice the allowed percentage
B. Incorrect dosing
C. One within ±7.5%
C. Bitter taste
D. One that is broken
D. Delayed shipment
15. The effect of particle size distribution is:
A. Enhances flavor
B. Promotes capping
21. If 3 out of 20 tablets exceed the weight variation limit, the ACTIVITY 02: Friability, Thickness, and Hardness (Items 26–50)
batch is:
26. What is the friability test used to measure?
A. Accepted
A. Color uniformity
B. Failed
B. Moisture content
C. Released
C. Mechanical strength
D. Modified
D. Coating thickness
22. The upper limit of tablet weight is calculated using:
27. Which instrument is used in friability testing?
A. Mean – deviation
A. Calorimeter
B. Average weight – %error
B. Spectrometer
C. Average weight + (avg × %error)
C. Friabilator
D. Average weight × 2
D. Thermometer
23. Which dosage form is commonly used in the weight variation
28. The acceptable weight loss in friability test is:
test?
A. Not more than 2.0%
A. Suppository
B. Not more than 1.0%
B. Capsule
C. Not more than 0.5%
C. Syrup
D. Not more than 1.5%
D. Ointment
29. Tablets are rotated in the friabilator for how many revolutions?
24. Over-lubrication during manufacturing can lead to:
A. 10
A. Consistent dose
B. 50
B. Variation in weight
C. 100
C. Better color
D. 150
D. Slower drying
30. What must be done before and after the friability test?
25. The weight variation test ensures:
A. Freeze the tablets
A. Faster absorption
B. Weigh individually
B. Tablet beauty
C. Dedust the tablets
C. Uniform active ingredient
D. Color-code the tablets
D. Larger tablet size
31. When is the friability test repeated? 37. A Monsanto tester is used for:
A. Always A. Coating tablets
B. If tablets are coated B. Weighing capsules
C. If weight loss exceeds limits C. Measuring hardness
D. If tablets are chewable D. Filtering excipients
32. Which instrument measures tablet thickness? 38. Tablet hardness influences:
A. Friabilator A. Color
B. Hardness tester B. Shelf life
C. Vernier caliper C. Disintegration and dissolution
D. Burette D. Binder strength
33. Tablet thickness affects: 39. Excessive friability results in:
A. Smell A. Strong tablets
B. Disintegration B. Shiny appearance
C. Weight C. Crumbled tablets
D. Aesthetics and dosage D. Increased coating
34. An inconsistent tablet thickness may indicate: 40. Which is not a cause of high friability?
A. Proper drying A. Over-drying
B. Uneven compression B. Weak binder
C. Too much coating C. High compression
D. Short expiry D. Over-lubrication
35. The principle behind the hardness test is: 41. Units of tablet hardness include all EXCEPT:
A. Temperature testing A. N (Newton)
B. Color intensity B. kgf
C. Breaking force C. mg/L
D. Lubrication D. lbf
36. Acceptable hardness range for uncoated tablets is: 42. Tablets with low hardness are prone to:
A. 1–3 kg A. Dissolution
B. 4–10 kg B. Breakage
C. 11–20 kg C. Coating
D. 2–6 kg D. Fragmentation
43. Why is friability testing crucial? 49. Friability testing simulates:
A. For appearance A. Storage temperature
B. For shipping durability B. Human swallowing
C. For moisture retention C. Handling and transport stress
D. For odor control D. In vivo metabolism
44. The most common tool for measuring thickness is: 50. Which step is done after friability rotation?
A. Friabilator A. Coating
B. Spectrophotometer B. Dedusting and re-weighing
C. Vernier caliper C. Mixing
D. Tablet press D. Packaging
45. Thickness is usually recorded in:
A. Degrees
B. Milliliters ANSWER KEY
C. Millimeters Activity 01: Weight Variation (1–25)
D. Seconds
1. C – To assess dosage uniformity
46. Which of the following is a formulated tablet?
A. Pure API 2. C – 20
B. Powder mix 3. C – 10%
C. Compressed solid dosage form
D. Capsule shell 4. C – USP

47. What is the main risk of under-hard tablets? 5. A – ±5%

A. Too thick 6. B – Hardness tester
B. Poor color
C. Breaking during packaging 7. B – Total weight ÷ 20
D. Overdosing
8. C – To assess uniformity
48. The vernier caliper can measure:
9. C – Powder density variation
A. Tablet flavor
B. Tablet coating 10. A – Over-coating
C. Tablet diameter and thickness
11. A – 5%
D. Tablet odor
 12. C – Retest or reject the batch 32. C – Vernier caliper
13. B – To ensure correct dosage 33. D – Aesthetics and dosage
14. B – One that deviates twice the allowed percentage 34. B – Uneven compression
15. C – Causes segregation 35. C – Breaking force
16. B – Filling consistency 36. B – 4–10 kg
17. C – Humidity and temperature 37. C – Measuring hardness
18. C – Irregular weight 38. C – Disintegration and dissolution
19. B – Assure efficacy and safety 39. C – Crumbled tablets
20. B – Incorrect dosing 40. C – High compression
21. B – Failed 41. C – mg/L
22. C – Average weight + (avg × %error) 42. B – Breakage
23. B – Capsule 43. B – For shipping durability
24. B – Variation in weight 44. C – Vernier caliper
25. C – Uniform active ingredient 45. C – Millimeters
46. C – Compressed solid dosage form
Activity 02: Friability, Thickness, and Hardness (26–50) 47. C – Breaking during packaging
26. C – Mechanical strength 48. C – Tablet diameter and thickness
27. C – Friabilator 49. C – Handling and transport stress
28. B – Not more than 1.0% 50. B – Dedusting and re-weighing
29. C – 100
30. C – Dedust the tablets
31. C – If weight loss exceeds limits