Servicios
Stabilities
Stability evaluation to ensure quality, shelf life, and regulatory compliance for your products.
Design, execution, and control of stability studies under regulatory guidelines, with analytical support and regulatory compliance.
Stability that supports quality
We develop stability studies that allow us to evaluate product performance over time, ensuring safety, efficacy, and regulatory compliance. We assist our clients from study design through to results interpretation.
Study design
Comprehensive project management
Climate chamber rental
Development of indicative methods
Validation of indicative methods
We provide support in all or any of the following stages of the life cycle of an analytical method (together or separately)
1. Study design
Preparation of stability protocols and programs, including the selection of the container-closure system, according to ICH Q1A (R2) and NOM-073-SSA1-2015 guidelines.
2. Study management
We coordinate the complete execution of the study: schedule, analysis, documentation, and client communication.
We perform analyses at the times defined by the stability protocol, depending on the indicative stability method.
3. Climate chamber rental
Availability of chambers under controlled conditions for different climate zones, according to the requirements of the study.
Not applicable to products requiring refrigeration or freezing.
4. Development of indicative methods
Design of analytical methods specific to each molecule, considering degradation susceptibility.
5. Validation of IE method
We validate stability-indicating methods to ensure that they detect relevant degradation products or impurities.
Applicable Industries
Regulatory Framework
Stability studies are carried out according to national and international regulatory guidelines, including ICH Q1A (R2) and NOM-073-SSA1-2015, ensuring compliance and validity of results.
We support our clients throughout the entire stability process, from study design to results interpretation, ensuring execution aligned with their technical and regulatory objectives.
Do you need to evaluate your product's stability?
We help you design, execute, and analyze stability studies to ensure quality, compliance, and shelf life.