What is a Stability Study? (Simple Definition)
A pharmaceutical stability study is a series of tests performed on a drug substance (API) or drug product (finished formulation) to determine how its quality, safety, and efficacy change over time under the influence of environmental factors — primarily temperature, humidity, and light. The data generated is used to establish an approved shelf life (expiry date) and recommended storage conditions for labelling.
In simple terms: a stability study answers two critical questions every patient and regulator asks about a medicine:
- “How long does this medicine stay safe and effective?” → Establishes the shelf life / expiry date
- “How should this medicine be stored?” → Defines labelling storage conditions (e.g. “Store below 25°C”)
An unstable product can be dangerous. Degradation products may be toxic. A sub-potent product may fail to treat the patient. An over-potent product may cause toxicity. Without stability data, no medicine can receive regulatory approval anywhere in the world. ICH Q1A(R2) is the global standard that defines exactly how this testing must be done.
The ICH Q1 Stability Guideline Series
Stability testing in pharma is governed by a series of related ICH guidelines. Understanding the full picture helps you know which document to consult for each aspect of your study:
Guideline |
Title |
What It Covers |
|---|---|---|
ICH Q1A(R2)
|
Stability Testing of New Drug Substances and Products
|
The master guideline — storage conditions, timepoints, batch requirements, packaging, data evaluation. This is the primary reference for all stability studies.
|
ICH Q1B
|
Photostability Testing
|
Testing of drug substances and products for sensitivity to light. Defines light exposure levels (visible + UV).
|
ICH Q1C
|
Stability Testing for New Dosage Forms
|
When a new dosage form is developed from an already-approved drug substance.
|
ICH Q1D
|
Bracketing and Matrixing Designs
|
Reduced testing designs — test only extremes (bracketing) or a subset of all samples (matrixing) when scientifically justified.
|
ICH Q1E
|
Evaluation of Stability Data
|
Statistical approaches for data analysis and shelf life estimation — regression analysis, pooling of batches.
|
WHO TRS 953
|
WHO Stability Guidelines for APIs and FPPs
|
WHO version — used for generic submissions in developing markets and WHO prequalification.
|
ICH Climatic Zones — Which Zone Is Your Market?
ICH Q1A(R2) divides the world into four climatic zones based on the mean annual temperature and relative humidity of each region. The zone of your target market determines your long-term storage conditions.
🌤
21°C / 45% RH
Long-term conditions
Countries:
UK, Germany, Netherlands, Scandinavia, Northern Europe, Canada
🌤
25°C / 60% RH
Most common long-term condition
Countries:
USA, Japan, EU (most), Australia, South Africa, China
☀
30°C / 35% RH
Less commonly required
Countries:
Iran, Iraq, Sudan, dry regions of Africa & Middle East
🌧
30°C / 75% RH
Harshest long-term condition
Countries:
India, Pakistan, Bangladesh, Brazil, Nigeria, SE Asia, WHO submissions
Zone IVa (30°C/65% RH) was the original WHO tropical condition. Zone IVb (30°C/75% RH) was introduced in a 2015 WHO update and is now the required condition for most developing market submissions including India (CDSCO), Pakistan (DRAP), and WHO Prequalification. If you are targeting any tropical market, always use Zone IVb conditions to be safe.
All Storage Conditions — Long-Term, Accelerated & Intermediate
Primary data for shelf life — most submissions
Temperature
25°C ± 2°C
Humidity (RH)
60% ± 5%
Min. Duration
12 months (submission) / 24–36 months (approval)
Timepoints
0, 3, 6, 9, 12, 18, 24, 36 months
Purpose
Define shelf life in temperate/subtropical markets
Early prediction — detect problems fast
Temperature
40°C ± 2°C
Humidity (RH)
75% ± 5%
Duration
6 months minimum
Timepoints
0, 3, 6 months
Purpose
Early shelf life prediction; detect instability before long-term data available
Required if significant change at accelerated
Temperature
30°C ± 2°C
Humidity (RH)
65% ± 5%
Duration
6 months minimum (up to 12)
Timepoints
0, 6 months minimum
Purpose
Triggered when significant change occurs at 40°C/75% RH accelerated conditions
For India, Pakistan, Brazil, WHO submissions
Temperature
30°C ± 2°C
Humidity (RH)
75% ± 5%
Min. Duration
12 months (submission)
Timepoints
0, 3, 6, 9, 12, 18, 24 months
Purpose
Define shelf life for hot and humid tropical markets
Special Storage Conditions (Refrigerated & Frozen Products)
Product Type |
Long-Term Condition |
Accelerated Condition |
Key Note |
|---|---|---|---|
Refrigerated products (e.g. biologics, vaccines, suspensions)
|
5°C ± 3°C
|
25°C ± 2°C / 60% RH (6 months)
|
Significant change at accelerated → no intermediate; use long-term data only
|
Frozen products (e.g. frozen biologics, blood products)
|
-20°C ± 5°C
|
5°C ± 3°C (case by case)
|
No standard accelerated; study conducted on case-by-case basis
|
Below -20°C products
|
-70°C ± 10°C (typical)
|
Case by case
|
Timepoints and conditions defined in individual protocol
|
What Parameters to Test in a Stability Study
Not every test in the product specification needs to be run at every stability timepoint. ICH Q1A(R2) requires testing of parameters that are susceptible to change during storage and are likely to influence quality, safety, or efficacy.
Test Parameter |
Guideline Ref |
T=0 |
3M |
6M |
9M |
12M |
18M |
24M |
36M |
|---|---|---|---|---|---|---|---|---|---|
Appearance / Description
|
ICH Q6A
|
✓
|
✓
|
✓
|
✓
|
✓
|
✓
|
✓
|
✓
|
Assay (% Label Claim)
|
ICH Q2(R1) / USP
|
✓
|
✓
|
✓
|
✓
|
✓
|
✓
|
✓
|
✓
|
Related Substances / Degradants
|
ICH Q3B / Q6A
|
✓
|
✓
|
✓
|
✓
|
✓
|
✓
|
✓
|
✓
|
Water Content (Karl Fischer)
|
USP <921>
|
✓
|
*
|
✓
|
*
|
✓
|
✓
|
✓
|
✓
|
Dissolution / Disintegration
|
USP <711> / <701>
|
✓
|
*
|
✓
|
*
|
✓
|
✓
|
✓
|
✓
|
Hardness / Friability (solid)
|
USP <1217> / <1216>
|
✓
|
–
|
✓
|
–
|
✓
|
*
|
✓
|
✓
|
pH (liquid / semi-solid)
|
USP <791>
|
✓
|
✓
|
✓
|
✓
|
✓
|
✓
|
✓
|
✓
|
Particulate Matter (injectables)
|
USP <788>
|
✓
|
*
|
✓
|
*
|
✓
|
✓
|
✓
|
✓
|
Sterility (sterile products)
|
USP <71>
|
✓
|
–
|
✓
|
–
|
✓
|
–
|
✓
|
✓
|
Microbial Limits / Bioburden
|
USP <61> / <62>
|
✓
|
–
|
✓
|
–
|
✓
|
–
|
✓
|
✓
|
Reconstitution Time (if applicable)
|
Product specific
|
✓
|
*
|
✓
|
*
|
✓
|
✓
|
✓
|
✓
|
✓ = Required at this timepoint | * = Perform if data at previous timepoint shows concern | – = Not required (but may be performed optionally)
How Many Batches Are Required?
ICH Q1A(R2) specifies minimum batch requirements for stability submissions. These requirements exist to ensure the stability data represents the variability of commercial manufacturing.
Study Type |
Minimum Batches |
Batch Size Requirement |
Notes |
|---|---|---|---|
New Drug Substance (API)
|
3 batches
|
Pilot scale or larger (≥ 1/10th commercial or 10kg, whichever is larger)
|
From same manufacturing process and representative of commercial scale
|
New Drug Product
|
3 batches
|
Pilot scale (≥ 1/10th of commercial batch or 100,000 units, whichever is larger)
|
2 of 3 batches should be at least pilot scale; manufactured to represent commercial process
|
Abbreviated NDA / Generic
|
3 batches (long-term) 1 batch (accelerated)
|
As above
|
FDA may accept 1 batch at accelerated for initial submission with commitment to complete 3
|
Post-Approval Changes (SUPAC)
|
1–3 batches
|
Depends on level of change
|
Level I change may need 1 batch; Level III change requires 3 batches as for new drug product
|
The stability batches must be truly representative of the commercial manufacturing process. Using specially optimised "golden" batches that perform better than typical commercial production is not acceptable. Regulators specifically look for evidence that batches were manufactured using the commercial process, equipment, and scale.
Container Closure System — Critical for Stability
Stability studies must be conducted in the same container closure system proposed for marketing. The packaging material directly affects how temperature and moisture interact with the product.
Packaging Type |
Moisture Barrier |
Stability Impact |
Special Requirement |
|---|---|---|---|
HDPE bottle + desiccant
|
High
|
Low humidity sensitivity expected
|
Test with and without desiccant if both are options
|
Aluminium-Aluminium blister (Alu/Alu)
|
Highest
|
Minimum moisture/light impact
|
Standard for moisture-sensitive tablets
|
PVC/Aluminium blister (PVC/Alu)
|
Moderate
|
Some moisture permeation possible
|
May need additional moisture studies for hygroscopic products
|
Glass vial + rubber stopper (sterile)
|
High for moisture; container integrity critical
|
Must test container integrity and particulate
|
Container closure integrity test (USP <1207>) required
|
Tubes (semi-solids)
|
Variable by material
|
Test at inverted and upright orientation
|
Drug-container interaction study may be needed
|
Significant Change Criteria — When to Take Action
ICH Q1A(R2) defines significant change as any result that falls outside these boundaries at accelerated conditions (40°C/75% RH). If significant change occurs at accelerated conditions, the intermediate condition (30°C/65% RH) must be studied.
Parameter |
Significant Change Definition (ICH Q1A(R2)) |
Action Required |
|---|---|---|
Assay
|
A 5% change in assay from the initial (T=0) value
|
Initiate intermediate study; evaluate impact on shelf life; consider CAPA
|
Degradation Products
|
Any specified degradation product exceeding its acceptance criterion (specification limit)
|
Evaluate toxicological significance (ICH Q3B thresholds); regulatory notification may be required
|
Physical Attributes
|
Failure to meet the acceptance criteria for appearance, colour change, phase separation, cracking, caking, or hardness
|
Investigate root cause; evaluate if change impacts patient usability or safety
|
pH
|
pH falls outside the approved specification limits
|
Investigate formulation stability; evaluate impact on drug absorption and product safety
|
Dissolution / Disintegration
|
A 12-point drop in dissolution (e.g. Q drops from ≥85% to ≤73%) OR failure to meet disintegration time specification
|
Critical — impacts bioavailability. Full investigation; regulatory notification required if marketed product affected
|
Particulate Matter (injectables)
|
Failure to comply with compendial limits (USP <788> / <789>)
|
Critical safety concern. Immediate investigation; batch quarantine; consider recall if distributed
|
Sterility
|
Failure of sterility test (USP <71>)
|
Most serious outcome. Immediate regulatory notification; batch recall; full CAPA investigation
|
Photostability Testing (ICH Q1B)
All drug substances and drug products must be evaluated for sensitivity to light as part of the stability programme. ICH Q1B defines two testing approaches:
Standard approach — single exposure to defined light
Visible light exposure
≥ 1.2 million lux·hours
UV light exposure
≥ 200 W·hr/m²
Sample presentation
Exposed vs. foil-wrapped control
Testing conditions
Cool white fluorescent + near UV lamps
Suitable for most finished products. Exposes product directly to defined light intensity and compares with protected control.
Compare exposed vs. protected control
- Appearance / colour change
- Assay — % degradation from initial
- Degradation products — any new photodegradants?
- pH (liquids and semi-solids)
- Clarity / turbidity (solutions)
Labelling outcome:
If photosensitive, label must state
“Protect from light” or “Store in original container.”
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Stress Testing (Forced Degradation Studies)
Forced degradation (stress testing) is conducted during development to understand the degradation pathways of the drug substance and inform the formulation, packaging, and analytical method development. It is not the same as formal stability testing — it uses more extreme conditions to deliberately degrade the drug.
Conditions: 50°C, 60°C, 70°C (dry heat)
Duration: 1–4 weeks
- Identifies thermally-induced degradation
- Helps set stability chamber temperatures
- Predicts shelf life at lower temperatures
Acid: 0.1N – 1N HCl, ambient or 60°C
Base: 0.1N – 1N NaOH, ambient or 60°C
Neutral: Water, 60°C
- Ester, amide, and lactam hydrolysis
- Reveals pH-sensitive degradation
- Informs buffering strategy
Conditions: 3–5% H₂O₂ solution
Or: exposure to O₂ atmosphere
- Identifies oxidation-prone groups
- Informs need for antioxidants
- Sets limits for oxygen-sensitive packaging
Conditions: ICH Q1B light chamber or sunlamp
Expose for 1–5× ICH Q1B dose
- Identifies photodegradation pathways
- Informs packaging (amber glass, foil blister)
- Sets monitoring wavelengths for HPLC
Conditions: 90% RH at 25°C or 40°C
Duration: 2–4 weeks (open dish)
- Hygroscopicity assessment
- Impact of moisture on solid dosage forms
- Informs desiccant / packaging selection
For: Liquid formulations, biologics
Cycles: 3–5 cycles (-20°C 25°C)
- Protein aggregation (biologics)
- Emulsion/suspension stability
- Crystal formation in solutions
Stress testing results are NOT included in regulatory shelf life calculations. They are development tools to understand degradation chemistry and validate your analytical methods. Formal stability data (long-term and accelerated in ICH-specified conditions) is what determines the approved shelf life.
Bracketing & Matrixing — Reduced Study Designs (ICH Q1D)
Testing every combination of strength, pack size, and container type at every timepoint can be extremely costly. ICH Q1D allows reduced testing designs when scientifically justified.
ICH Q1D §2.1 — Test only extremes
Only the extreme strengths and pack sizes are placed on full stability. Intermediate strengths/sizes are assumed to be covered by the extremes.
Example: Product available in 25mg, 50mg, 75mg, and 100mg tablets. Only 25mg and 100mg are placed on stability. The 50mg and 75mg are assumed to be covered by the bracket.
Justified when: Strengths differ only in tablet weight (not formulation composition) and use the same manufacturing process.
ICH Q1D §2.2 — Reduced timepoints per batch
Only a defined subset of all samples is tested at each timepoint. Different samples are tested at different timepoints so all are evaluated across the study but not at every point.
Example: 3 batches, 8 timepoints. Matrixing design assigns only 2 of 3 batches to be tested at each intermediate timepoint, while all 3 are always tested at T=0, 12M, and 24M.
Not suitable for: Products with known instability or products where there is high batch-to-batch variability.
Shelf Life Estimation — How to Calculate Expiry Date
The shelf life (expiry date) is determined from the long-term stability data using statistical analysis as defined in ICH Q1E. The goal is to find the time point at which the 95% lower confidence interval of the assay regression line intersects the lower specification limit.
Shelf Life Estimation — ICH Q1E Linear Regression Approach
Step 1: Plot assay (% label claim) against time (months) for each batch
Step 2: Test whether the batches can be pooled (analysis of covariance; ICH Q1E uses a 0.25 significance level)
– Slopes and intercepts not significantly different → pool all batches
– Slopes equal, intercepts different → common slope, separate intercepts; shelf life from the worst batch
– Slopes different → estimate shelf life for each batch and use the shortest
Step 3: Fit the regression line
y = a + b×t
y = assay (%), t = time (months), a = intercept, b = slope
Step 4: Calculate the 95% one-sided lower confidence limit (for an attribute that decreases)
LCL(t) = ŷ(t) − t(0.05, n−2) × s × √[1/n + (t − t̄)²/Sxx]
s = residual standard deviation of the regression
Step 5: Shelf life = time at which LCL(t) meets the lower specification limit (e.g. 90.0%)
Example result: LCL reaches 90.0% at month 26
→ Proposed shelf life = 24 months (round down to a completed time point; extrapolation beyond the real-time data is limited by ICH Q1E)
At NDA/ANDA submission: You typically have 12 months of long-term data and 6 months of accelerated data. FDA allows up to a 2× extrapolation of real-time data if accelerated data shows no significant change — so 12 months real-time may support a provisional 24-month shelf life.
Full approval: Requires 24 months of long-term data for a 24-month shelf life; 36 months for a 36-month shelf life. Post-approval commitments to continue the study are standard.
Step-by-Step: How to Design & Execute a Stability Study
1
Write the Stability Protocol
Must be QA-approved before any samples are placed on stability
Every stability study begins with a written, QA-approved protocol. It must define:
- Product name, strength, dosage form, batch numbers, and manufacturing date
- Study type: long-term, accelerated, intermediate, photostability, stress
- Storage conditions: temperature, humidity, and tolerances
- Container closure system to be used on study
- Number of samples per timepoint and orientation (upright / inverted)
- Testing schedule with exact timepoints and allowable pull windows
- Test parameters and specification limits for each parameter
- Analytical methods to be used (reference to validated SOPs)
- Significant change criteria and action plan
- Statistical method for shelf life calculation (reference to ICH Q1E)
2
Qualify Stability Chambers
Equipment qualification is mandatory before placing samples
All stability chambers must be qualified (IQ/OQ/PQ) and continuously monitored. Key requirements:
- Temperature and humidity sensors calibrated and within specification
- Temperature mapping study performed (demonstrates uniformity throughout chamber)
- Continuous temperature/humidity data logging with alarm system
- Excursion procedure defined: what to do if temperature or humidity falls outside limits
- Back-up chamber or procedure for power failure events
- Chamber capacity calculated to avoid overcrowding (poor air circulation affects conditions)
3
Prepare & Label Stability Samples
Labelling must include all information needed to pull and test correctly
Stability samples are placed in the container closure system exactly as intended for market. Label each sample container with:
- Product name and strength
- Batch number
- Study condition (e.g. "40°C / 75% RH — Accelerated")
- Storage orientation if specified (upright / inverted)
- Planned pull date for each timepoint
- Stability study reference number
Maintain a Stability Sample Inventory Log tracking all samples placed, remaining quantities, and pull dates.
4
Pull Samples at Each Timepoint
Pull within the allowed time window — not early, not late
ICH Q1A(R2) defines allowable pull windows around each nominal timepoint to account for weekends, holidays, and laboratory scheduling:
Nominal Timepoint |
Acceptable Pull Window |
|---|---|
3 months
|
3 months ± 7 days
|
6 months
|
6 months ± 7 days
|
9 months
|
9 months ± 7 days
|
12 months
|
12 months ± 14 days
|
18 months
|
18 months ± 30 days
|
24 months and beyond
|
Nominal ± 30 days
|
Never pull early to be convenient. If a pull falls outside the allowed window without documented justification, the data may be considered unacceptable by regulators. Plan your pull schedule at the start of the study and put calendar reminders for every timepoint.
Test & Record Results
All testing per validated analytical methods — ALCOA+ at all times
Test pulled samples per all parameters defined in the protocol. Results must be:
- Recorded contemporaneously with date, time, and analyst signature
- Entered into the stability data management system or electronic lab notebook
- Checked against acceptance criteria immediately — any OOS triggers investigation
- Any trend approaching a specification limit flagged as OOT for investigation
- QC supervisor review of each timepoint data before release
Evaluate Data & Write Stability Report
Statistical analysis per ICH Q1E; complete report with QA approval
At the end of the study (or at key submission milestones), compile all data into a formal Stability Report. It must include:
- Summary table of all results at all timepoints for all conditions and batches
- Trend plots (assay, impurities, dissolution) for each batch and condition
- Statistical analysis: regression analysis, poolability assessment (ANOVA), LCL calculations
- Significant change assessment with conclusion
- Shelf life and storage condition recommendations with scientific justification
- Proposed label statement (e.g. "Store below 25°C. Use within 24 months of manufacture.")
- QA review and approval signature
10 Common Stability Study Mistakes
# |
Mistake |
Why It Matters |
The Correct Approach |
|---|---|---|---|
1
|
Starting stability before protocol approval
|
Data may be rejected by regulators; no approved baseline defined
|
Protocol must be QA-approved before first sample is placed on study
|
2
|
Using non-representative "golden" batches
|
FDA considers this data unreliable; does not represent commercial product
|
Use batches manufactured by the exact commercial process at pilot scale minimum
|
3
|
Pulling samples outside the time window
|
Data may be invalid; regulators check pull dates against certificates
|
Plan pull schedule in advance; document any justified deviations
|
4
|
Chamber excursion not investigated
|
Data from excursion period is compromised; shelf life calculations affected
|
All excursions must be documented, investigated, and their impact on data assessed
|
5
|
Confusing stress testing with formal stability
|
Using stress data to claim shelf life is scientifically invalid
|
Stress testing is for development only; shelf life is based on ICH Q1A conditions
|
6
|
Ignoring OOT results
|
A trend toward failure is as important as an actual failure — it predicts future OOS
|
Define OOT criteria in protocol; investigate and document all OOT observations
|
7
|
Not testing in commercial packaging
|
Packaging change after validation means stability data may not be applicable
|
Always test in the same packaging proposed for marketing
|
8
|
Assigning shelf life longer than supported by data
|
FDA/EMA extrapolation rules are strict; overstating shelf life is a serious violation
|
Shelf life = time supported by real data + allowed extrapolation per ICH Q1A(R2)
|
9
|
Missing intermediate study after accelerated failure
|
Required by ICH Q1A(R2); failure to add it is a regulatory deficiency
|
Define in protocol that intermediate study will be initiated if significant change occurs at accelerated
|
10
|
No statistical analysis in stability report
|
ICH Q1E requires regression analysis and LCL calculation; visual inspection alone is not acceptable
|
Use validated statistical software (SAS, Minitab, R) for shelf life calculation per ICH Q1E
|
Frequently Asked Questions
A full stability study for a 24-month shelf life claim runs for at least 24 months in long-term conditions (Zone I/II: 25°C/60% RH). However, pharmaceutical companies initiate stability studies during development, long before regulatory submission. At the time of NDA/ANDA submission, a minimum of 12 months of long-term data and 6 months of accelerated data is required. The study continues after approval under a post-approval commitment until the full proposed shelf life duration is covered.
Accelerated stability data (40°C/75% RH, 6 months) can be used to support extrapolation of long-term data, but not to replace it. Per ICH Q1A(R2), if there is no significant change at accelerated conditions AND the long-term trend is consistent, regulators may accept extrapolation up to twice the duration of the available long-term data. For example, 12 months of long-term data with no accelerated failure could support a provisional 24-month shelf life claim. However, continuation of the long-term study to confirm the full shelf life is required as a post-approval commitment.
Shelf life (expiry date) applies to drug products (finished formulations). It is the period during which the product is expected to remain within its approved specification when stored under defined conditions. Retest date applies to drug substances (APIs). It is the date after which the drug substance should be re-examined to ensure it is still suitable for use, rather than a hard expiry. After the retest date, the material can still be used if re-tested and found to comply with the specification — the substance has not necessarily “expired.”
An OOS result during a stability study requires a full OOS investigation following the same procedure as a release OOS (FDA OOS Guidance 2006). If the OOS is confirmed (not a laboratory error), the batch must be evaluated. If the OOS occurred before the end of the assigned shelf life, the shelf life must be reduced or, in serious cases, a product recall may be required if the batch is already in the market. The stability protocol should already define the action plan for an OOS at each condition and timepoint.
Yes. Generic drug products (ANDAs) require the same type and quality of stability data as new drug products. The FDA requires at minimum 12 months long-term and 6 months accelerated data at submission for ANDAs. The storage conditions must match the proposed labelling claim and the market intended (Zone IVb for tropical markets). Shortened or reduced studies without proper scientific justification (bracketing/matrixing per ICH Q1D) are not acceptable.
Key Regulatory References
Reference |
What It Covers |
|---|---|
ICH Q1A(R2) — Stability Testing of New Drug Substances and Products
|
Master guideline — storage conditions, timepoints, batch requirements, significant change criteria, data evaluation for new molecular entities
|
ICH Q1B — Photostability Testing
|
Light exposure requirements for drug substances and products; defines visible and UV light levels and sample presentation
|
ICH Q1C — New Dosage Forms
|
Stability requirements when a new dosage form is derived from an existing, approved drug substance
|
ICH Q1D — Bracketing and Matrixing
|
Reduced stability study designs — conditions and scientific justification requirements
|
ICH Q1E — Evaluation of Stability Data
|
Statistical methods for shelf life estimation — regression analysis, poolability testing, confidence interval approach
|
WHO TRS 953 — WHO Stability Guidelines for APIs and FPPs
|
WHO version of stability guidance — required for WHO prequalification and many developing market submissions including Zone IVb conditions
|
FDA Guidance — Q1A(R2) Stability Testing
|
FDA implementation guidance for ICH Q1A(R2) in the US regulatory context; includes FDA-specific expectations for NDA/ANDA submissions
|
21 CFR 211.137
|
US legal requirement for expiration dating — requires stability data to support all expiry dates assigned to drug products
|
USP <1150> — Pharmaceutical Stability
|
USP guidance chapter — provides additional context and examples for pharmaceutical stability programmes
|
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