---
title: "稳定性研究 — Lab Services | QbD Group"
description: "QbD Group 以符合 ICH 要求的严格稳定性研究与先进设施，确保您的产品达到最高质量标准。"
url: https://qbdgroup.com/zh-cn/services/lab-services/stability-studies
type: "Page"
language: zh-cn
publisher: "QbD Group"
citation: "QbD Group, \"稳定性研究 — Lab Services | QbD Group\", https://qbdgroup.com/zh-cn/services/lab-services/stability-studies"
---

# Stability Studies

Protect the integrity and shelf-life of your products

QbD Group ensures your products meet the highest quality standards through rigorous ICH-compliant stability studies with state-of-the-art facilities.

## What are stability studies?

Stability studies are **scientific investigations to determine how the quality of a product varies with time** under environmental factors such as temperature, humidity, light, and pH. These studies assess the product's physical, chemical, microbiological, and functional properties over its lifecycle.

Key aspects include:
- **ICH stability testing**: Long-term, intermediate, and accelerated studies.
- **Stress testing**: Examining product responses to extreme conditions.
- **In-use stability testing**: Evaluating stability during typical usage conditions.
- **Temperature cycle tests**: Freeze-thaw and transportation simulations.
- **Validation of stability-indicating methods**: Tracking product degradation accurately.

## Why are stability studies essential?

### Regulatory compliance

Ensures your product meets the strict requirements of health authorities.

### Shelf-life determination

Helps establish appropriate storage conditions and expiry dates.

### Product quality assurance

Confirms that your product remains stable under specified conditions.

### Risk mitigation

Identifies potential stability issues during development.

### Market confidence

Assure customers and stakeholders of your product's quality.

### Support for global markets

Enables compliance with international guidelines like ICH.

### Cost efficiency

Identify potential issues early to avoid costly recalls or rework.

### Data-driven decision making

Optimize formulation, packaging, and storage conditions based on stability data.

## How can we help?

We offer a complete suite of stability study services tailored to your needs. Our ICH-compliant stability storage facilities are equipped with advanced technology for 24/7 monitoring, access control, and alarm systems to ensure the integrity of your samples.

### ICH stability testing

Conduct long-term, intermediate, and accelerated testing following ICH guidelines.

### Stress testing

Assess stability under challenging conditions, including light, pH, humidity, and oxidation.

### In-use stability testing

Evaluate stability during typical use scenarios.

### Temperature cycle tests

Simulate freeze-thaw cycles and transportation stress.

### Stability-indicating method development & validation

Ensure accurate tracking of product degradation.

### Comprehensive study management

From protocol development to reporting, we provide end-to-end support.

## Our process

A structured approach to stability testing that ensures compliance and reliability.

### 1. Study design

Defining protocols based on ICH guidelines and product requirements.

### 2. Sample storage

Placing samples in ICH-compliant stability chambers with 24/7 monitoring.

### 3. Testing

Conducting scheduled analyses at defined time points.

### 4. Reporting

Delivering comprehensive stability reports for regulatory submissions.

为什么选择QbD Group

## 您值得信赖的合作伙伴

With QbD Group, you gain:

Deep expertise

decades of experience in stability testing across various industries.

State-of-the-art facilities

fully secured, ICH-compliant stability storage.

Tailored solutions

customized testing strategies aligned with your product's requirements.

Regulatory support

in-depth understanding of global regulatory standards.

End-to-end services

from study design to execution, we manage every step.

## 聊聊实验室服务

从方法验证到稳定性研究,我们的实验室专家随时为您的分析需求提供支持。

联系我们

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Source: https://qbdgroup.com/zh-cn/services/lab-services/stability-studies — © QbD Group. Quote freely with attribution and a link back.