GMP stability studies and sample storage for pharmaceutical products.
ICH-compliant stability testing, controlled storage and analytics at one site.
We test and store your pharmaceutical products under defined conditions — GMP-compliant, ICH-aligned and transparently documented.
Our services include long-term stability studies, accelerated stability testing, photostability testing and GMP sample storage for development, regulatory submissions and ongoing quality control.
A key advantage:
at CUP, storage and analytics can be performed at the same site.
This reduces interfaces, avoids additional transport steps and supports consistent stability data. We also handle demanding product groups such as controlled substances, radiopharmaceuticals and radioactive medicinal products under controlled conditions.
Stability studies.
Storage, pull points, and analytics at one site.
CUP stores samples under defined and controlled conditions. Available storage options include 25 °C / 60% RH, 30 °C / 65% RH, 30 °C / 75% RH, 40 °C / 75% RH, refrigerated storage, and frozen storage. The selected condition depends on the target market, climatic zone, product matrix, packaging, and stability protocol.
Long-term stability studies show how a product behaves over its intended shelf life. They provide the scientific basis for shelf-life definition, storage instructions, and product quality assessment. Depending on the stability protocol, pull points may be scheduled at 0, 3, 6, 9, 12, 18, 24, 36, 48, and 60 months.
Accelerated stability studies evaluate how sensitive a product is to increased stress. They help detect early trends and make risks such as degradation products, loss of potency, or physical changes visible at an earlier stage. A typical condition is 40 °C / 75% RH with defined pull points.
Intermediate stability studies are positioned between long-term and accelerated conditions. They may be useful when accelerated studies show changes or when additional data are required to evaluate product stability. At CUP, storage at 30 °C / 65% RH is available.
For light-sensitive products, photostability testing may be required. The product is exposed to defined light conditions and then analyzed according to the agreed testing plan. This helps assess whether light causes degradation, discoloration, or other quality-relevant changes.
For products with specific temperature requirements, CUP offers refrigerated and frozen storage. Long-term studies can be performed, for example, at 5 °C or -20 °C. Pull points are defined according to the stability protocol and the intended shelf life.
In-use stability studies simulate how a product behaves after opening or during use. The study setup depends strongly on the product, application, packaging, and handling process. We therefore align the study design, storage conditions, and pull points with you on a project-specific basis.
On-going stability studies are used to monitor consistent product quality throughout the product lifecycle. They are usually designed as long-term studies. Responsibility for the stability protocol remains with the client. CUP supports storage, timely pull points, and analytics if required.
CUP pulls samples according to the agreed stability protocol. When the protocol is available, pull points can be organized according to the defined time schedule. Alternatively, the client informs CUP in advance about upcoming pull points. This keeps timelines, sample quantities, and next steps clearly planned.
Depending on the project, CUP can analyze pulled samples directly on site. This reduces additional transport, saves time, and lowers the risk of inconsistent conditions. Relevant tests may include assay, degradation products, pH value, water content, appearance, particulate matter, or further product-specific parameters.
CUP can store non-radioactive kits and, if required, label and analyze them directly afterwards. This is particularly relevant when storage, handling, and analytics are closely connected. The result is robust stability data without the need to transport samples between multiple sites.
Before study start, storage conditions, temperature, humidity, packaging, sample position, testing period, pull intervals, sample quantities, and special handling requirements should be defined. Based on this information, CUP checks capacities, open questions, and possible analytics. This enables a structured and reliable project start.
Storage condition
and their typical use.
Frequently asked questions about stability testing.
Key information on stability studies, GMP storage, and regulatory requirements.
Stability storage refers to the controlled storage of pharmaceutical samples under defined conditions. Samples are pulled at specified time points and tested according to the stability protocol. This generates stability data for shelf life, storage conditions, transport and regulatory decisions.
A stability study describes the complete testing concept. Stability testing refers to the analytical testing of the samples. Stability storage means the controlled storage of samples until the defined pull points.
Common conditions include 25 °C / 60% RH, 30 °C / 65% RH, 30 °C / 75% RH and 40 °C / 75% RH. Depending on the product, refrigerated, frozen or special storage conditions may also be required. The specific conditions depend on the product, target market, climatic zone, packaging system and regulatory strategy.
Yes. CUP supports stability studies and GMP storage for demanding product groups such as controlled substances, radiopharmaceuticals and radioactive medicinal products. Storage and analytics can be performed at the same site where required by the study protocol.
Yes. At CUP, stability storage and analytical testing can be performed at the same site. This reduces interfaces, avoids additional transport steps and supports consistent stability data.
Yes. CUP performs photostability testing. The product is exposed to light according to ICH Q1B and then analyzed according to the agreed testing protocol.
Photostability data are particularly important when drug substances, formulations, or packaging systems may be sensitive to light. The results support decisions on packaging, storage, labeling, and transport.
You receive documented stability data for the parameters defined in the testing protocol. Depending on the product, these may include assay, degradation products, pH value, water content, appearance, particulate matter, viscosity, or other product-specific quality attributes.
These data support the definition of shelf life, storage conditions, and transport conditions. They can also be used for trend analysis, quality evaluation, risk management, regulatory documentation, and lifecycle decisions.
Plan your stability study with confidence.
From sample storage to analytics at the same site.
Together, we clarify what your study needs.
Would you like to store samples, coordinate pull points, or combine storage with analytical testing? We review the requirements with you and support the next planning step.
