We use USP Purified Water across our manufacturing processes.
Up to 10 kg.
Yes. We support both real-time and accelerated stability studies on-site.
Our analytical capabilities include:
- Fourier Transform Infrared Spectroscopy (FTIR)
- High Performance Liquid Chromatography (HPLC)
- pH testing
- Brookfield viscosity
- Karl Fischer titration
- Conductivity
- Available Free Chlorine (AFC)
- Wet chemistry methods
Run rates vary depending on product type, viscosity, and packaging format. Please contact us for specific details.
Turnaround time depends on product complexity and production requirements. Please reach out for an accurate timeline.
From 1 cps to 1,400,000 cps.
Typically, 5,000 units for most sizes.
6-gallon, 45-gallon, 175-gallon, 500-gallon, and 2,000-gallon tanks.
Our operations comply with applicable regulatory and quality standards. Please contact us for specific certification details.
Yes, we support OTC product manufacturing.
We support fills as small as 4 mL tubes and 10 mL bottles.
Up to 1-gallon jugs. Larger sizes can be accommodated with adjusted run rates.
Yes. We maintain a robust formulation library with readily available options.
Our 100,000 sq. ft. facility includes:
- Class 7 and Class 8 clean rooms
- 12,000 sq. ft. converting and packaging space
- 5,000 sq. ft. USP liquid compounding and filling
- 5,000 sq. ft. 503B pharmaceutical compounding
- 600 sq. ft. chemistry lab
- 1,000 sq. ft. collagen compounding area
- 250 sq. ft. microbiology lab
Strukmyer Labs is FDA Drug and Device registered, ISO 13485:2016 certified, DEA and FDA registered for 503B drug compounding, and cGMP compliant. We operate Controlled Manufacturing Environments (CME) with ISO Class 7 and Class 8 clean rooms for pharmaceutical compounding, converting, packaging, and filling of liquids, powders, creams, and gels
Pharmaceutical stability testing determines how long a drug substance or product remains safe and effective under defined storage conditions through controlled storage and periodic testing.
Accelerated stability testing uses elevated temperatures to speed up product degradation and help predict long-term stability. This approach is generally not suitable for biological products due to more complex degradation pathways.
Samples are stored under controlled conditions and tested at defined intervals using selected release-specification assays. Testing is more frequent initially and decreases over time as stability data is established, ensuring efficiency while maintaining product integrity and safety throughout its shelf life.
The International Council for Harmonisation (ICH) provides globally accepted guidelines for stability testing. Our team follows applicable guidelines, including ICH Q1A(R2) and ICH Q5C, and implements bracketing and matrix designs in accordance with ICH Q1D where appropriate.
You can reach us via the contact form on our website or by calling our customer service hotline.
Monday through Friday, 9:00 AM – 5:00 PM CST.
We are based in Dallas, Texas, serving clients across the United States.
We strive to respond to all inquiries within 24 business hours.
Low pH environments may:
- Promote angiogenesis
- Increase tissue oxygenation (Bohr effect)
- Inhibit protease activity
- Reduce the growth of pathogens