STABILITY STUDY PROTOCOL

Lisinopril dihydrate equivalent to Lisinopril 10mg

Hydrochlorothiazide                                           12.5mg

The quality of drug product is likely to be influenced during storage. There are various factors involved, such as temperature, humidity, primary packing etc. for influencing drug product quality. Therefore it is necessary to evaluate the influence of these factors on product quality, establish the shelf life or evaluate storage conditions of the Drug Product (for new products). The stability is also carried out to ascertain that the existing products are stable till the end of their shelf life when studied as per defined schedule/interval & stability conditions.

The stability studies will be carried out to ensure the stability of the product till the end of its shelf life.

Preparation & Approval of Stability Protocol – QA

Sampling – IPQA Chemists

Charging & Withdrawal of Samples – QС Chemist

Monitoring Temperature & Humidity Conditions of Stability Chambers – QС Chemist

Analysis of Stability Samples – QC Chemist

Documentation & Reporting – Head QC

OOS Results if any – Head QC & Head of QA

Review of Data, Documentation & Reports & Conclusion – Head of QA

Head of QA

Sample quantity of any subjected batch contains samples for following requirements:

·         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 samples to be taken should be in market equivalent container i.e

In case of Lisinopril and Hydrochlorothiazide tablets 10+12.5 mg : 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 single analysis.

The samples will be drawn by IPQA Chemists & then handed over to QC department. This will be recorded.

Long Term Stability Studies at 25 + 2⁰C / 60 + 5 % RH.

Accelerated Stability Studies at 40 + 2⁰C / 75 + 5 % RH.

Zone IVb. Long Term Stability at 30 + 2⁰C / 75 + 5 % RH.

In case of breakdown / non functioning of any stability chamber; the samples will be shifted to the spare stability chamber after setting it to the required stability conditions.

The samples will have to be charged in the Stability chambers within 5 days of completion of 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As per the Calendar the samples are withdrawn within 5 days of the due date of analysis for Long Term Stability Studies and Long Term Stability Studies for Zone IVb and 3 days of the due date of analysis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.

The Product is packed in Alu-PVC/PVdC Blister is packed in cartons.

Significant change means:

a.       A 5% change in assay form initial value or failure to meet the acceptance criteria 90 % to 110 % of labeled amount.

b.      Related substances fail to meet the acceptance criteria.

c.       Fails to meet the microbial purity.

d.      Failure to meet the acceptance criteria for other parameters likes Description, DT, Dissolution, Assay, Chromatographic Purity & Microbial Purity & any other characteristics.

All the analytical Raw data carried out for stability will be retained in QC along with COA made for each sample from each station.