What types of stability studies does Pharmaffiliates offer?

Pharmaffiliates provides R&D stability, QC release studies, accelerated, long-term, photostability, comparator studies and stability-indicating analytical methods for APIs and finished dosage forms.

Do you offer stability studies for APIs, formulations and finished pharmaceutical products?

Yes, we perform stability studies for APIs, pharmaceutical formulations and finished dosage forms as per customer requirement.

Which guidelines does Pharmaffiliates follow for stability studies?

All stability studies are performed as per ICH guidelines including ICH Q1A to Q1F requirements and international regulatory expectations.

Can Pharmaffiliates develop stability-indicating methods before running long-term studies?

Yes, Pharmaffiliates develops stability-indicating analytical methods to ensure accurate evaluation of degradation, impurities and product shelf-life.

Are these studies acceptable for regulatory submissions and shelf-life assignment?

Yes, stability data generated at Pharmaffiliates is suitable for regulatory submissions, product release and shelf-life determination.

What information is required to start a stability study?

You need to provide the product type, dosage form, packaging details, storage requirements, expected conditions and any known stability concerns for proper protocol design.

What happens if the product fails stability or shows degradation?

If stability failure occurs, Pharmaffiliates supports degradation profiling, identifies root cause, and suggests formulation or storage modifications based on the study outcome.

How long does a stability study take?

Timelines depend on study type such as accelerated, long-term or photostability. A schedule is shared after evaluating product requirements.

Stability Studies | Drug Stability & Shelf-Life Testing

Fundamental criteria for the approval and acceptance of any drug product, stability investigations of pharmaceutical formulations are vital for assessing their efficacy and safety over the whole shelf life. Pharmaffiliates caters its clients with

R&D preliminary studies
Quality control stability studies and release testing
Comparator studies
Photostability studies

Stability tests at Pharmaffiliates are run according to ICH Q1A–Q1F standards. Applied on a broad spectrum of APIs and pharmaceutical items throughout stability testing, our Analytical Research Department creates strong stability-indicating techniques.

To guarantee data integrity and regulatory alignment, all run under standard operating procedures and totally compliant with 21 CFR Part 11, we use fully qualified stability equipment including walk-in chambers, stability ovens, and sophisticated analytical tools.

Related FAQs

Pharmaffiliates offers a broad range of stability services including R&D preliminary studies, quality-control stability studies and release testing, comparator studies, and photostability studies. :contentReference[oaicite:1]{index=1}

Stability studies can be carried out for APIs (drug substances), finished drug products, and associated pharmaceutical formulations — whichever are submitted by the client. :contentReference[oaicite:2]{index=2}

Studies are conducted in accordance with international standards — following ICH Q1A–Q1F Guidelines for stability testing and conditions. :contentReference[oaicite:4]{index=4}

The company uses fully qualified stability equipment such as stability ovens, walk-in chambers, and advanced analytical instruments. The labs are operated under standard operating procedures and are compliant with 21 CFR Part 11 for data integrity. :contentReference[oaicite:5]{index=5}

You will receive a full stability study report including stability-indicating method details, sampled data over time (e.g. assay, degradation products, physical/chemical changes), storage conditions, and any observations required for regulatory submission. :contentReference[oaicite:6]{index=6}

Yes — Pharmaffiliates’ Analytical Research Department develops stability-indicating analytical methods which are then used for stability testing of APIs and drug products. :contentReference[oaicite:7]{index=7}

Yes — the stability studies performed follow ICH guidelines and produce data accepted by regulatory authorities for shelf-life assignment, batch release, and long-term product quality assurance. :contentReference[oaicite:8]{index=8}

Timelines vary depending on study type (e.g. R&D preliminary, accelerated, long-term, photostability), product type, and storage conditions — exact duration and schedule will be defined in the protocol after assessing the product requirements.

You should provide the product type (API or formulation), packaging/container details, the dosage form (tablet, capsule, injectable, etc.), proposed storage conditions, any known stability concerns, and expected shelf-life specification or target market stability requirements. This helps Pharmaffiliates design the appropriate stability protocol.

If the product fails stability criteria, Pharmaffiliates can assist in identifying degradation pathways, re-optimizing formulation or packaging, or recommending suitable storage conditions — ensuring you get actionable data to remediate stability issues.