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Observe whether a tablet or capsule breaks down within a defined liquid, time and mechanical movement while keeping dosage-form conditions explicit
Read FDA’s final December 2009 Q4B Annex 5 through apparatus, basket rack, discs, medium, temperature, movement, dosage-form preparation, endpoint, staged testing, observations, investigations and lifecycle control.
Swallow a tablet and several things must happen before most drug molecules can dissolve: liquid enters, the structure weakens and the dosage form breaks apart. A disintegration test measures that physical breakdown under defined conditions.
FDA lists Q4B Annex 5, Disintegration Test General Chapter, as final guidance dated December 2009 and notes an FDA page update on 18 September 2017.
Did you know? Disintegration and dissolution are related but different. A tablet can break into small pieces and still release drug slowly if those pieces dissolve poorly.
For students, the moving basket-rack apparatus is a clear model of controlled variables: geometry, immersion, temperature, motion, time and a visual endpoint all have to agree.
Chapter index
Chapters 1–9: final December 2009 Q4B Annex 5
- 1. Annex 5 owns the pharmacopoeial disintegration intent
- 2. FDA lists Annex 5 as final guidance from December 2009
- 3. Disintegration measures physical breakdown under defined conditions
- 4. Dosage-form category determines the procedure
- 5. The basket-rack assembly creates repeatable movement
- 6. Discs are used only when the applicable method calls for them
- 7. The immersion medium controls wetting and structure change
- 8. Temperature keeps the physical process comparable
- 9. One dosage unit belongs in each tube
Chapters 10–17: tablets, capsules, apparatus, medium, temperature, endpoint and investigations
- 10. The clock begins at a defined procedural point
- 11. The endpoint is a defined observation rather than disappearance
- 12. Enteric or delayed-release products can require sequential media
- 13. Staged sampling rules preserve individual evidence
- 14. Acceptance uses the registered and pharmacopoeial requirement
- 15. An unusual result prompts a physical and procedural investigation
- 16. Lifecycle changes can shift disintegration behaviour
- 17. A complete Annex 5 receipt reconstructs the physical test
CHAPTER 1 OF 17 · Understand disintegration
1. Annex 5 owns the pharmacopoeial disintegration intent
The annex evaluates selected disintegration-test general chapters for use in ICH regions. It does not create one requirement for every dosage form or replace registered product specifications.
The scientific value of annex 5 owns the pharmacopoeial disintegration intent appears when the observation, method and quality decision remain connected. The annex evaluates selected disintegration-test general chapters for use in ICH regions. It does not create one requirement for every dosage form or replace registered product specifications. Keep this boundary visible: Disintegration does not measure dissolution or clinical performance directly.
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Build an evidence receipt for annex 5 owns the pharmacopoeial disintegration intent. Trace annex 5 owns the pharmacopoeial disintegration intent from dosage-form category through apparatus, medium, time and endpoint. Add the source version, equipment identity and acceptance rule. Keep this limit: Disintegration does not measure dissolution or clinical performance directly.
A strong science note separates observation from interpretation. Trace annex 5 owns the pharmacopoeial disintegration intent from dosage-form category through apparatus, medium, time and endpoint. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Trace annex 5 owns the pharmacopoeial disintegration intent from dosage-form category through apparatus, medium, time and endpoint. Keep this boundary visible: Disintegration does not measure dissolution or clinical performance directly.
CHAPTER 2 OF 17 · Understand disintegration
2. FDA lists Annex 5 as final guidance from December 2009
The official page identifies final status, docket FDA-2008-D-0399 and CDER and CBER as issuing offices. A method receipt records the annex, current pharmacopoeial text and regional implementation.
For fda lists annex 5 as final guidance from december 2009, a reliable result depends on both the material and the controlled measurement system. The official page identifies final status, docket FDA-2008-D-0399 and CDER and CBER as issuing offices. A method receipt records the annex, current pharmacopoeial text and regional implementation. Preserve this guardrail: Dosage-form category determines the applicable medium, discs and stages.
Try this
Challenge the assumptions behind fda lists annex 5 as final guidance from december 2009. Challenge geometry, discs, temperature and visual interpretation behind fda lists annex 5 as final guidance from december 2009. Test one realistic failure mode and record what changes. Respect this boundary: Dosage-form category determines the applicable medium, discs and stages.
A strong science note separates observation from interpretation. Challenge geometry, discs, temperature and visual interpretation behind fda lists annex 5 as final guidance from december 2009. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Challenge geometry, discs, temperature and visual interpretation behind fda lists annex 5 as final guidance from december 2009. Keep this boundary visible: Dosage-form category determines the applicable medium, discs and stages.
CHAPTER 3 OF 17 · Understand disintegration
3. Disintegration measures physical breakdown under defined conditions
The dosage unit is repeatedly immersed in a controlled liquid until no relevant firm core remains under the chapter’s endpoint. The result is operational and does not by itself measure dissolved drug or bioavailability.
A trustworthy account of disintegration measures physical breakdown under defined conditions keeps preparation, apparatus, timing, calculation and review in one traceable route. The dosage unit is repeatedly immersed in a controlled liquid until no relevant firm core remains under the chapter’s endpoint. The result is operational and does not by itself measure dissolved drug or bioavailability. Remember: A visual endpoint needs trained interpretation and contemporaneous observations.
Try this
Audit the laboratory route for disintegration measures physical breakdown under defined conditions. Reconstruct disintegration measures physical breakdown under defined conditions unit by unit instead of relying on an average time. Mark every handoff where identity, contamination, time or units could be lost. Preserve this caution: A visual endpoint needs trained interpretation and contemporaneous observations.
A strong science note separates observation from interpretation. Reconstruct disintegration measures physical breakdown under defined conditions unit by unit instead of relying on an average time. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Reconstruct disintegration measures physical breakdown under defined conditions unit by unit instead of relying on an average time. Keep this boundary visible: A visual endpoint needs trained interpretation and contemporaneous observations.
CHAPTER 4 OF 17 · Understand disintegration
4. Dosage-form category determines the procedure
Uncoated, film-coated, sugar-coated, enteric-coated, soluble, dispersible, capsule or other presentations can require different conditions or stages. The analyst confirms the category rather than choosing the fastest-looking method.
The scientific value of dosage-form category determines the procedure appears when the observation, method and quality decision remain connected. Uncoated, film-coated, sugar-coated, enteric-coated, soluble, dispersible, capsule or other presentations can require different conditions or stages. The analyst confirms the category rather than choosing the fastest-looking method. Keep this boundary visible: The registered specification and regional text still govern acceptance.
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Build an evidence receipt for dosage-form category determines the procedure. Reassess dosage-form category determines the procedure after a formulation, compression, coating, shell or storage change. Add the source version, equipment identity and acceptance rule. Keep this limit: The registered specification and regional text still govern acceptance.
A strong science note separates observation from interpretation. Reassess dosage-form category determines the procedure after a formulation, compression, coating, shell or storage change. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Reassess dosage-form category determines the procedure after a formulation, compression, coating, shell or storage change. Keep this boundary visible: The registered specification and regional text still govern acceptance.
CHAPTER 5 OF 17 · Control the apparatus
5. The basket-rack assembly creates repeatable movement
Tubes, mesh, dimensions, vertical travel and frequency follow the apparatus specification. Wear, bent components or obstruction can change mechanical stress. Equipment qualification keeps motion and geometry within the intended design.
For the basket-rack assembly creates repeatable movement, a reliable result depends on both the material and the controlled measurement system. Tubes, mesh, dimensions, vertical travel and frequency follow the apparatus specification. Wear, bent components or obstruction can change mechanical stress. Equipment qualification keeps motion and geometry within the intended design. Preserve this guardrail: Disintegration does not measure dissolution or clinical performance directly.
Try this
Challenge the assumptions behind the basket-rack assembly creates repeatable movement. Trace the basket-rack assembly creates repeatable movement from dosage-form category through apparatus, medium, time and endpoint. Test one realistic failure mode and record what changes. Respect this boundary: Disintegration does not measure dissolution or clinical performance directly.
A strong science note separates observation from interpretation. Trace the basket-rack assembly creates repeatable movement from dosage-form category through apparatus, medium, time and endpoint. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Trace the basket-rack assembly creates repeatable movement from dosage-form category through apparatus, medium, time and endpoint. Keep this boundary visible: Disintegration does not measure dissolution or clinical performance directly.
CHAPTER 6 OF 17 · Control the apparatus
6. Discs are used only when the applicable method calls for them
A disc can keep a unit immersed and add mechanical interaction. Disc material, dimensions and free movement matter. Adding or omitting discs changes the challenge and must not be an analyst preference.
A trustworthy account of discs are used only when the applicable method calls for them keeps preparation, apparatus, timing, calculation and review in one traceable route. A disc can keep a unit immersed and add mechanical interaction. Disc material, dimensions and free movement matter. Adding or omitting discs changes the challenge and must not be an analyst preference. Remember: Dosage-form category determines the applicable medium, discs and stages.
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Audit the laboratory route for discs are used only when the applicable method calls for them. Challenge geometry, discs, temperature and visual interpretation behind discs are used only when the applicable method calls for them. Mark every handoff where identity, contamination, time or units could be lost. Preserve this caution: Dosage-form category determines the applicable medium, discs and stages.
A strong science note separates observation from interpretation. Challenge geometry, discs, temperature and visual interpretation behind discs are used only when the applicable method calls for them. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Challenge geometry, discs, temperature and visual interpretation behind discs are used only when the applicable method calls for them. Keep this boundary visible: Dosage-form category determines the applicable medium, discs and stages.
CHAPTER 7 OF 17 · Control the apparatus
7. The immersion medium controls wetting and structure change
Water, simulated gastric fluid, buffer or another specified liquid provides the chemical environment. Volume, identity, pH and freshness are controlled. A medium appropriate to one dosage-form stage may be wrong for another.
The scientific value of the immersion medium controls wetting and structure change appears when the observation, method and quality decision remain connected. Water, simulated gastric fluid, buffer or another specified liquid provides the chemical environment. Volume, identity, pH and freshness are controlled. A medium appropriate to one dosage-form stage may be wrong for another. Keep this boundary visible: A visual endpoint needs trained interpretation and contemporaneous observations.
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Build an evidence receipt for the immersion medium controls wetting and structure change. Reconstruct the immersion medium controls wetting and structure change unit by unit instead of relying on an average time. Add the source version, equipment identity and acceptance rule. Keep this limit: A visual endpoint needs trained interpretation and contemporaneous observations.
A strong science note separates observation from interpretation. Reconstruct the immersion medium controls wetting and structure change unit by unit instead of relying on an average time. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Reconstruct the immersion medium controls wetting and structure change unit by unit instead of relying on an average time. Keep this boundary visible: A visual endpoint needs trained interpretation and contemporaneous observations.
CHAPTER 8 OF 17 · Control the apparatus
8. Temperature keeps the physical process comparable
The liquid is maintained within the specified range using a qualified bath and calibrated measurement. Temperature affects gelatin, coatings, binders and liquid viscosity, so actual conditions stay in the raw record.
For temperature keeps the physical process comparable, a reliable result depends on both the material and the controlled measurement system. The liquid is maintained within the specified range using a qualified bath and calibrated measurement. Temperature affects gelatin, coatings, binders and liquid viscosity, so actual conditions stay in the raw record. Preserve this guardrail: The registered specification and regional text still govern acceptance.
Try this
Challenge the assumptions behind temperature keeps the physical process comparable. Reassess temperature keeps the physical process comparable after a formulation, compression, coating, shell or storage change. Test one realistic failure mode and record what changes. Respect this boundary: The registered specification and regional text still govern acceptance.
A strong science note separates observation from interpretation. Reassess temperature keeps the physical process comparable after a formulation, compression, coating, shell or storage change. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Reassess temperature keeps the physical process comparable after a formulation, compression, coating, shell or storage change. Keep this boundary visible: The registered specification and regional text still govern acceptance.
Units are placed without damage and identified to position. Floating, sticking, swelling and interaction with the mesh or disc are observed. Crowding or swapping positions would break the one-unit evidence route.
A trustworthy account of one dosage unit belongs in each tube keeps preparation, apparatus, timing, calculation and review in one traceable route. Units are placed without damage and identified to position. Floating, sticking, swelling and interaction with the mesh or disc are observed. Crowding or swapping positions would break the one-unit evidence route. Remember: Disintegration does not measure dissolution or clinical performance directly.
Try this
Audit the laboratory route for one dosage unit belongs in each tube. Trace one dosage unit belongs in each tube from dosage-form category through apparatus, medium, time and endpoint. Mark every handoff where identity, contamination, time or units could be lost. Preserve this caution: Disintegration does not measure dissolution or clinical performance directly.
A strong science note separates observation from interpretation. Trace one dosage unit belongs in each tube from dosage-form category through apparatus, medium, time and endpoint. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Trace one dosage unit belongs in each tube from dosage-form category through apparatus, medium, time and endpoint. Keep this boundary visible: Disintegration does not measure dissolution or clinical performance directly.
CHAPTER 10 OF 17 · Observe the endpoint
10. The clock begins at a defined procedural point
Start time, immersion, apparatus movement and observation follow the procedure. Actual elapsed time is recorded. An imprecise start or delayed observation can matter when the result sits near the limit.
The scientific value of the clock begins at a defined procedural point appears when the observation, method and quality decision remain connected. Start time, immersion, apparatus movement and observation follow the procedure. Actual elapsed time is recorded. An imprecise start or delayed observation can matter when the result sits near the limit. Keep this boundary visible: Dosage-form category determines the applicable medium, discs and stages.
Try this
Build an evidence receipt for the clock begins at a defined procedural point. Challenge geometry, discs, temperature and visual interpretation behind the clock begins at a defined procedural point. Add the source version, equipment identity and acceptance rule. Keep this limit: Dosage-form category determines the applicable medium, discs and stages.
A strong science note separates observation from interpretation. Challenge geometry, discs, temperature and visual interpretation behind the clock begins at a defined procedural point. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Challenge geometry, discs, temperature and visual interpretation behind the clock begins at a defined procedural point. Keep this boundary visible: Dosage-form category determines the applicable medium, discs and stages.
CHAPTER 11 OF 17 · Observe the endpoint
11. The endpoint is a defined observation rather than disappearance
Fragments of insoluble coating or capsule shell may remain under permitted conditions, while a palpable firm core may mean incomplete disintegration. Analysts train against the chapter definition and record unusual appearance.
For the endpoint is a defined observation rather than disappearance, a reliable result depends on both the material and the controlled measurement system. Fragments of insoluble coating or capsule shell may remain under permitted conditions, while a palpable firm core may mean incomplete disintegration. Analysts train against the chapter definition and record unusual appearance. Preserve this guardrail: A visual endpoint needs trained interpretation and contemporaneous observations.
Try this
Challenge the assumptions behind the endpoint is a defined observation rather than disappearance. Reconstruct the endpoint is a defined observation rather than disappearance unit by unit instead of relying on an average time. Test one realistic failure mode and record what changes. Respect this boundary: A visual endpoint needs trained interpretation and contemporaneous observations.
A strong science note separates observation from interpretation. Reconstruct the endpoint is a defined observation rather than disappearance unit by unit instead of relying on an average time. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Reconstruct the endpoint is a defined observation rather than disappearance unit by unit instead of relying on an average time. Keep this boundary visible: A visual endpoint needs trained interpretation and contemporaneous observations.
CHAPTER 12 OF 17 · Observe the endpoint
12. Enteric or delayed-release products can require sequential media
An acid stage can demonstrate resistance before transfer to a buffer stage that permits disintegration. Time, transfer and observations remain separate. Passing the second stage cannot erase failure in the first.
A trustworthy account of enteric or delayed-release products can require sequential media keeps preparation, apparatus, timing, calculation and review in one traceable route. An acid stage can demonstrate resistance before transfer to a buffer stage that permits disintegration. Time, transfer and observations remain separate. Passing the second stage cannot erase failure in the first. Remember: The registered specification and regional text still govern acceptance.
Try this
Audit the laboratory route for enteric or delayed-release products can require sequential media. Reassess enteric or delayed-release products can require sequential media after a formulation, compression, coating, shell or storage change. Mark every handoff where identity, contamination, time or units could be lost. Preserve this caution: The registered specification and regional text still govern acceptance.
A strong science note separates observation from interpretation. Reassess enteric or delayed-release products can require sequential media after a formulation, compression, coating, shell or storage change. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Reassess enteric or delayed-release products can require sequential media after a formulation, compression, coating, shell or storage change. Keep this boundary visible: The registered specification and regional text still govern acceptance.
CHAPTER 13 OF 17 · Use the result wisely
13. Staged sampling rules preserve individual evidence
The pharmacopoeial procedure defines the initial number of units and any additional testing. Extra units are tested only under those rules, not because the first result was inconvenient. Every unit and stage remains traceable.
The scientific value of staged sampling rules preserve individual evidence appears when the observation, method and quality decision remain connected. The pharmacopoeial procedure defines the initial number of units and any additional testing. Extra units are tested only under those rules, not because the first result was inconvenient. Every unit and stage remains traceable. Keep this boundary visible: Disintegration does not measure dissolution or clinical performance directly.
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Build an evidence receipt for staged sampling rules preserve individual evidence. Trace staged sampling rules preserve individual evidence from dosage-form category through apparatus, medium, time and endpoint. Add the source version, equipment identity and acceptance rule. Keep this limit: Disintegration does not measure dissolution or clinical performance directly.
A strong science note separates observation from interpretation. Trace staged sampling rules preserve individual evidence from dosage-form category through apparatus, medium, time and endpoint. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Trace staged sampling rules preserve individual evidence from dosage-form category through apparatus, medium, time and endpoint. Keep this boundary visible: Disintegration does not measure dissolution or clinical performance directly.
CHAPTER 14 OF 17 · Use the result wisely
14. Acceptance uses the registered and pharmacopoeial requirement
Observed completion times and unit outcomes are compared with the applicable criterion. Reporting an average can hide a nonconforming unit when the rule is based on individual performance.
For acceptance uses the registered and pharmacopoeial requirement, a reliable result depends on both the material and the controlled measurement system. Observed completion times and unit outcomes are compared with the applicable criterion. Reporting an average can hide a nonconforming unit when the rule is based on individual performance. Preserve this guardrail: Dosage-form category determines the applicable medium, discs and stages.
Try this
Challenge the assumptions behind acceptance uses the registered and pharmacopoeial requirement. Challenge geometry, discs, temperature and visual interpretation behind acceptance uses the registered and pharmacopoeial requirement. Test one realistic failure mode and record what changes. Respect this boundary: Dosage-form category determines the applicable medium, discs and stages.
A strong science note separates observation from interpretation. Challenge geometry, discs, temperature and visual interpretation behind acceptance uses the registered and pharmacopoeial requirement. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Challenge geometry, discs, temperature and visual interpretation behind acceptance uses the registered and pharmacopoeial requirement. Keep this boundary visible: Dosage-form category determines the applicable medium, discs and stages.
CHAPTER 15 OF 17 · Use the result wisely
15. An unusual result prompts a physical and procedural investigation
Analysts preserve timing, unit position, apparatus data, medium, temperature and dosage-form observations. Potential causes include compression, coating, shell cross-linking, storage, moisture, formulation, equipment or procedural error.
A trustworthy account of an unusual result prompts a physical and procedural investigation keeps preparation, apparatus, timing, calculation and review in one traceable route. Analysts preserve timing, unit position, apparatus data, medium, temperature and dosage-form observations. Potential causes include compression, coating, shell cross-linking, storage, moisture, formulation, equipment or procedural error. Remember: A visual endpoint needs trained interpretation and contemporaneous observations.
Try this
Audit the laboratory route for an unusual result prompts a physical and procedural investigation. Reconstruct an unusual result prompts a physical and procedural investigation unit by unit instead of relying on an average time. Mark every handoff where identity, contamination, time or units could be lost. Preserve this caution: A visual endpoint needs trained interpretation and contemporaneous observations.
A strong science note separates observation from interpretation. Reconstruct an unusual result prompts a physical and procedural investigation unit by unit instead of relying on an average time. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Reconstruct an unusual result prompts a physical and procedural investigation unit by unit instead of relying on an average time. Keep this boundary visible: A visual endpoint needs trained interpretation and contemporaneous observations.
CHAPTER 16 OF 17 · Use the result wisely
16. Lifecycle changes can shift disintegration behaviour
Excipient, granulation, compression, coating, capsule shell, packaging, humidity or storage changes can alter wetting and breakup. Change control connects the test to formulation and process understanding.
The scientific value of lifecycle changes can shift disintegration behaviour appears when the observation, method and quality decision remain connected. Excipient, granulation, compression, coating, capsule shell, packaging, humidity or storage changes can alter wetting and breakup. Change control connects the test to formulation and process understanding. Keep this boundary visible: The registered specification and regional text still govern acceptance.
Try this
Build an evidence receipt for lifecycle changes can shift disintegration behaviour. Reassess lifecycle changes can shift disintegration behaviour after a formulation, compression, coating, shell or storage change. Add the source version, equipment identity and acceptance rule. Keep this limit: The registered specification and regional text still govern acceptance.
A strong science note separates observation from interpretation. Reassess lifecycle changes can shift disintegration behaviour after a formulation, compression, coating, shell or storage change. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Reassess lifecycle changes can shift disintegration behaviour after a formulation, compression, coating, shell or storage change. Keep this boundary visible: The registered specification and regional text still govern acceptance.
CHAPTER 17 OF 17 · Use the result wisely
17. A complete Annex 5 receipt reconstructs the physical test
The record includes annex and chapter versions, product and batch, dosage-form category, units and positions, apparatus and qualification, discs, medium and pH, temperature, movement, start and endpoint times, observations, staged testing, criterion, deviations, investigation and review.
For a complete annex 5 receipt reconstructs the physical test, a reliable result depends on both the material and the controlled measurement system. The record includes annex and chapter versions, product and batch, dosage-form category, units and positions, apparatus and qualification, discs, medium and pH, temperature, movement, start and endpoint times, observations, staged testing, criterion, deviations, investigation and review. Preserve this guardrail: Disintegration does not measure dissolution or clinical performance directly.
Try this
Challenge the assumptions behind a complete annex 5 receipt reconstructs the physical test. Trace a complete annex 5 receipt reconstructs the physical test from dosage-form category through apparatus, medium, time and endpoint. Test one realistic failure mode and record what changes. Respect this boundary: Disintegration does not measure dissolution or clinical performance directly.
A strong science note separates observation from interpretation. Trace a complete annex 5 receipt reconstructs the physical test from dosage-form category through apparatus, medium, time and endpoint. Record the source, version or date, population or device context, method, result and one uncertainty. If the official record does not show a field, write “not shown” instead of filling the gap from memory.
Evidence checkpoint
Trace a complete annex 5 receipt reconstructs the physical test from dosage-form category through apparatus, medium, time and endpoint. Keep this boundary visible: Disintegration does not measure dissolution or clinical performance directly.
Disintegration evidence map
| Question | Evidence to capture | Boundary to retain |
|---|---|---|
| What is tested? | Defined dosage-form category and units | Choose the correct procedure |
| What is the challenge? | Basket rack, medium, discs and temperature | Control mechanics and chemistry |
| What is observed? | Time and defined physical endpoint | Train visual judgement |
| How is it used? | Individual-unit acceptance and investigation | Do not equate with dissolution |
Science learning becomes useful when a student can show where a claim came from, why it applies and where it stops. Continue with the eduKate Science Learning Hub, compare choices in the Education Hub, and connect these habits to career pathways built from subject capabilities.
Annex 5 makes a familiar event—tablets breaking apart—scientifically repeatable. When apparatus, liquid, clock and endpoint are disciplined, a simple observation becomes useful evidence about dosage-form consistency.
Primary sources and verification date
Source status checked 26 October 2026. FDA guidance describes the agency’s current thinking and does not replace applicable statutes, regulations or product-specific communication with FDA.
- FDA: Q4B Annex 5 Disintegration Test — Final guidance, December 2009; FDA page updated 18 September 2017; checked 26 October 2026.
- ICH: Quality Guidelines — Official Q4B annex index and harmonisation context.
- FDA: Q4B Core Guidance — Final Q4B process guidance, February 2008.