Physical stability is of paramount importance for developing therapeutic drugs. It must be understood as degradation or inactive products lead to loss of efficacy and may cause side effects or even toxicities. Creative Biolabs provides a full range of stability evaluation services that adhere to International Conference on Harmonization (ICH) guidelines Q1A and Q1B, covering requirements for climate zones I to IV.

The purpose of stability testing is to provide evidence on how the efficiency and integrity of a drug substance or drug product (including its packaging) vary with time under the influence of a variety of physical, chemical or microbiological changes, such as temperature, PH, humidity, light, and radiations. The process ensures a pharmaceutical product is safe and efficient, irrespective of different environmental conditions in the world. Moreover, our stability testing service establishes the shelf life, storage conditions, and retest periods for active pharmaceutical ingredient (API) or finished pharmaceutical product (FPP).

Pharmaceutical Stability Testing Figure 1 Parallel degradation pathways for pralidoxime leading to cyanide formation under basic pH conditions. (Yoshioka and Stella 2002)

Creative Biolabs conducts several stability studies and downstream analytical tests. Our capabilities include:

  • Accelerated stress studies and forced degradation studies
  • Photostability testing
  • Stability storage
  • Degradation products testing

Accelerated Stress Studies and Forced Degradation Studies

The purpose of these two programs is intended to identify the likely degradation products which further helps in determining the intrinsic stability of the molecule, establishing degradation pathways, and validating the stability indicating procedures. The conditions used in forced degradation are more severe than those in accelerated degradation. We have the flexibility to set up the standard and non-standard temperature/humidity conditions upon request, as well as freeze/thaw cycle studies.

Photostability Testing

Photostability testing is an important part of stability testing to ensure that your drug products will hold up when exposing to the sun and UV rays. Testing products are placed under controlled light sources (lamps having output similar to standard daylight or white fluorescent lamps and near-W fluorescent lamps) with broad spectrum output. Testing samples are compared with control samples to determine if significant changes occur. Creative Biolabs also offers forced degradation studies under a variety of lighting conditions.

Stability Storage

ICH divides the world into five climatic zones based on a combination of temperature and relative humidity. This division ensures that the climatic differences in various regions of the world are taken into consideration for stability studies. Creative Biolabs conducts long-term stability studies subjecting to all of the five ICH climatic zone conditions. We provide storage units with validated conditions of temperature, humidity, and light. Moreover, a validated computerized system is provided for the continuous monitoring with cumulative reports.

Degradation Products Testing

To identify, track, and quantify degradation products, Creative Biolabs provides analytical and synthetic services. We are able to establish degradation pathways of drug substances, elucidate the structure of degradation products, synthesis of degradation products, and reveal the degradation mechanisms to support ongoing stability assessments.

With an extensive portfolio of services, Creative Biolabs has the equipment and expertise to support clients throughout the stability testing process and beyond. For more detailed information, please feel free to contact us or directly sent us an inquiry.

Reference

  1. Yoshioka S and Stella V J (2002) “Stability of Drugs and Dosage Forms.” Publisher: Springer US. DOI:10.1007/b114443
  2. Blessy M, Patel R D, Prajapati P N et al. (2014) “Development of forced degradation and stability indicating studies of drugs—A review” Journal of Pharmaceutical Analysis 4(3):159-165

Related Services:

Online Inquiry

Name:
*Phone:
*E-mail Address:
*Service & Products Interested:
Project Description:
*Verification Code:
Please input "biolabs"(case insensitive) as verification code.

Contact Us

USA
45-1 Ramsey Road, Shirley, NY 11967, USA
Tel: 1-631-381-2994
Fax: 1-631-207-8356
Email:
Europe
Tel: 44-207-097-1828
Email:

Follow us on:
Copyright ©2011 - 2020 Creative Biolabs.