STABILITY TESTING OF PHARMACEUTICALS
At nuvalore, we specialize in ICH and GMP-compliant stability testing of pharmaceuticals to ensure your drug product meets global regulatory standards from preclinical development through commercial launch. As a cornerstone of pharmaceutical quality, stability testing of pharmaceuticals plays a critical role in verifying that products remain safe, effective, and compliant throughout their intended shelf life. Our drug stability testing services are trusted by leading pharmaceutical and biotech companies, including those operating in FDA-inspected and EMA-compliant facilities. With a focus on accuracy, consistency, and regulatory alignment, our end-to-end stability programs support confident market release.
What Is Stability Testing of Pharmaceuticals and Why It Matters
Stability testing of pharmaceuticals is the process of evaluating how a drug product maintains its identity, strength, quality, and purity over time under the influence of environmental factors such as temperature, humidity, and light. This form of drug stability testing is critical for:
- Establish shelf life (expiration date)
- Recommend storage conditions (e.g., „Store at room temperature“)
- Ensuring product safety and efficacy
- Supporting regulatory submissions (FDA, EMA, WHO)
Our Stability Testing Capabilities
We provide comprehensive, ICH-compliant stability testing of pharmaceuticals to assess how these products perform under various storage and handling conditions. These studies support shelf-life determination, regulatory submissions, and overall product quality throughout its lifecycle.
| Type | Purpose | Conditions | Typcal Duration |
|---|---|---|---|
| Real-time Testing / Long-Term Testing | Testing at recommended long-term storage conditions | e.g., 25°C ± 2°C / 60% RH ± 5% | 12 to 60 months (12 or 24 months initially) |
| Accelerated Testing | Testing drugs under elevated temperature and humidity to predict long-term stability quickly | e.g., 40°C ± 2°C / 75% RH ± 5% | 6 months |
| Intermediate Testing | Testing conducted at moderately elevated conditions if the accelerated data is | e.g., 30°C ± 2°C / 65% RH ± 5% | 6 months |
| Stress Testing | Testing drugs under extreme conditions to intentionally cause degradation | Extreme heat, light, humidity, oxidation | Tage bis Wochen |
| In-Use Testing | Testing a drug remains safe, effective, and physically stable during the time it is administered or handled after opening, dilution, or preparation | Vials, reconstituted powders, IV bags, etc. | Varies |
*RH: Relative Humidity
GMP-Aligned, Globally Compliant
At nuvalore, we follow GMP guidelines to support global compliance. Our quality systems are designed for data integrity and regulatory confidence.
- Compliance with ICH guidelines and requirements set by regulatory authorities, including FDA and EMA.
- Electronic data capture with full audit trails
- Inspection-ready documentation and reporting
- Validated computer systems
Why Choose Us for Drug Stability Testing
We bring deep scientific rigor and regulatory insight to every drug stability testing program. Our clients rely on us for dependable, data-driven support across every phase of drug development. Here’s what sets us apart:
- We offer deep expertise in drug development and analytical quality control, built on decades of collective experience
- Equipped to perform comprehensive stability studies in accordance with regulatory standards
- Protocols customized to your product’s phase and regulatory path
- Seamless cross-functional collaboration (QA, Regulatory, CMC)
- On-time delivery and rapid report turnaround
Sample Workflow: From Protocol Design to Submission-Ready Report
1. Protocol Development
→ Strategically designed stability protocols aligned with ICH guidelines, customized to your product’s formulation, packaging, and regulatory path.
2. Sample Receipt & Controlled Storage
→ Immediate logging and placement into qualified stability chambers under GMP-controlled conditions to ensure sample integrity from day one.
3. Stability Testing at Defined Intervals
→ Execution of drug stability testing at ICH-specified timepoints, using validated, stability-indicating methods.
4. Data Analysis & Quality Review
→ Rigorous data evaluation, statistical analysis, and QA oversight to confirm regulatory compliance, accuracy, and consistency.
5. Comprehensive Report Delivery
→ We provide stability study reports with complete data sets and, when infrastructure is in place, can input results directly into the customer’s LIMS system.
Industries & Molecules We Support
We support a wide range of drug modalities and development stages, with stability programs tailored to the unique requirements of each product type and regulatory pathway.
- Biologics & Biosimilars
- Small Molecule APIs & Drug Products
- Injectables, Orals, Topicals
- Preclinical to Commercial Stage Products
- Support during Investigational New Drug (IND) and New Drug Application (NDA) submissions
Let’s Design a Stability Program That Works for You
Our experts are ready to create a custom protocol for stability testing of pharmaceuticals that aligns with your product’s characteristics, development stage, and regulatory objectives.
Frequently Asked Questions About Drug Stability Testing
Typical conditions include 25°C/60% RH (long-term), 30°C/65% RH (intermediate), and 40°C/75% RH (accelerated).
The duration depends on the type of study and regulatory requirements. Real-time studies typically span 12 to 36 months, while accelerated studies are completed in about 6 months. Stress testing may take only days to a few weeks, and in-use testing timelines vary based on the product’s intended use and handling.
Yes, our programs are scalable from clinical trial material to post-approval products.
Yes, all stability chambers are validated and continuously monitored with alarm and backup systems.
Ready to move your molecule forward with confidence?
nuvalore GmbH
Paul-Ehrlich-Str. 1
D – 69181 Leimen
Fon
+49 (6224) 179 966 0
