- Objective
- Scope
- Responsibility
- Selection of Batches for Stability
- Sampling
- Stability Conditions
- Charging & Withdrawal of Samples
- Product Details
- Stability Attributes & Specifications
- Acceptance Criteria
- Stability Testing Schedule
- Stability Commitments
- Documentation & Reporting
- Conclusion
- References
- Revision History
- Annexures
Quality Assurance: |
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Quality Control: |
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- Sample required for one complete analysis for each time point.
- Total quantity for all time points
- One additional pack for any unforeseen event like OOS.
- Placebo sample for each time point analysis.
- The sampling required for Stability Studies is to be drawn by IPQA Chemist on Packing Line. The samples to be taken should be in market equivalent containers i.e. In case it will be packed in Alu-Alu blister in a printed carton.
- The sample quantity will be calculated to 1 pack extra in addition to the packs required for a single analysis.
- The samples will be drawn by IPQA Chemists & then handed over to the QC department.
- This will be recorded.
- Long Term Stability Studies at 25 ± 2°C / 60 ± 5% RH.
- Accelerated Stability Studies at 40 ± 2°C / 75 ± 5% RH.
- Zone IVb. Long Term Stability at 30 ± 2°C / 75 ± 5% RH.
- The samples will be charged after putting the sticker labels on each pack.
- The samples will have to be charged in the Stability chambers within 5 days of completion of the Initial Analysis.
- As per the Calendar, the samples are withdrawn within 5 days of the due date of analysis for Long Term Stability Studies and Long Term Stability Studies for Zone IVb and 3 days of the due date of analysis for Accelerated Stability Studies.
- The analysis of the samples will have to be done within 15 days from the due date of analysis.
- In case of any deviation, this will be documented with justification & with approval from QA.
CONTENTS: | Each uncoated tablet contains: | ||
SHELF LIFE: | 24 months |
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DOSAGE FORM: | Tablet | ||
MANUFACTURED AT: | PharmaGuide Ltd. | ||
TYPE OF STABILITY STUDIES | Accelerated Stability Studies | 40 ± 2°C 75 ± 5 % RH. | 6 months |
Long-Term Stability Studies | 25 ± 2°C 60 ± 5 % RH. | 36 months | |
Zone IVb. Long Term Stability | 30 ± 2°C 75 ± 5 % RH. | 36 months |
Sr. No. | Tests | Specifications |
1 | Description | White to off-white, round, flat, uncoated tablet, plain on both sides. |
2 | Identification
| In the Assay, the principal peak in the chromatogram obtained with the test solution has the same retention time as the principal peak in the chromatogram obtained with the reference solution |
3 | Disintegration | NMT 15 minutes |
4 | Dissolution | NLT 75 % in 45 min |
5 | Assay | Between 95% to 105% |
6 | Uniformity of dosage units | XXX |
7 | Related substances | XXX |
- The Product is considered to be stable if it passes all the criteria for the Specifications mentioned above or if there is no significant change.
- Significant change means:
- 5% change in assay form initial value or failure to meet the acceptance criteria 90% to 110% of the labeled amount.
- Related substances fail to meet the acceptance criteria.
- Fails to meet microbial purity.
- Failure to meet the acceptance criteria for other parameters like Description, DT, Dissolution, Assay, Chromatographic Purity & Microbial Purity & any other characteristics.
| Accelerated | Long Term Stability Zone IVb. | ||||||||
Tests |
Initial | 3 M | 6 M | 3 M | 6 M | 9 M | 12 M | 18 M | 24 M | 36 M |
Description |
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Identification |
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Disintegration |
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Dissolution |
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Assay |
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Uniformity of dosage units |
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Related Substances |
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Microbial Purity |
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