FaSSGF: Fasted State Simulated Gastric Fluid (pH 1.6, with Pepsin, Sterile-Filtered) BZ379
Product Code: BZ379
Manufacturer: Biochemazone
Available Pack Sizes: 100 mL, 200 mL, 500 mL, 1 L
Custom Bulk Quantities Available
Product Overview
Biochemazone FaSSGF – Fasted State Simulated Gastric Fluid BZ379 is a ready-to-use biorelevant gastric medium that reproduces the composition and pH 1.6 of human gastric fluid in the fasted state. It is prepared on the FaSSGF model – sodium chloride and dilute hydrochloric acid with low, fasted-state levels of bile salt (sodium taurocholate) and lecithin and the gastric enzyme pepsin – and is sterilised by 0.2 µm filtration, so it can be used directly in dissolution, disintegration and stability studies.
Compared with simple compendial media such as USP Simulated Gastric Fluid (pH 1.2), the trace bile salt / lecithin content and pepsin of FaSSGF give a more predictive picture of the wetting, solubility and release behaviour of poorly soluble drugs, lipid-based formulations and gelatin capsules in the empty stomach. Prepared with ISO 3696 compliant high-purity water under Biochemazone’s ISO 9001 / GMP quality system, each batch is standardised for pH and composition so that dissolution profiles are reproducible between runs and laboratories. An enzyme-free version, a preservative-free version and a Powder Version Kit (2-year shelf life, reconstituted fresh before use) are available on request.
BZ379 is used in pharmaceutical development for biorelevant dissolution of tablets, capsules, pellets and softgels, for the gastric stage of two-stage (FaSSGF → FaSSIF) and transfer dissolution models, for stability, precipitation and food-effect screening, for excipient and enteric-coating evaluation, in nutraceutical and probiotic acid-tolerance studies, and in academic research and teaching on gastric physiology. Companion media – FeSSGF fed-state gastric fluid, FaSSIF / FeSSIF intestinal fluids, USP SGF, rat and canine gastric fluids – are also available.
Key Features & Benefits
✅ Fasted-State pH 1.6 – Representative of the resting human stomach; more physiological than pH 1.2 compendial media
✅ FaSSGF Composition – Sodium chloride, hydrochloric acid, fasted-state sodium taurocholate and lecithin, pepsin
✅ Pepsin Included – Enzyme-active medium for gelatin capsules and protein-containing dosage forms (enzyme-free version on request)
✅ Sterile-Filtered (0.2 µm) – Ready to use; suitable for extended incubation and microbial-sensitive studies
✅ ISO 3696 Grade Water – Prepared using high-purity laboratory water standards
✅ Reproducible & Standardized – Consistent batch-to-batch composition for comparative dissolution work
✅ Made in Canada – Manufactured under ISO 9001 / GMP quality systems
Applications
💊 Biorelevant Dissolution Testing
• Tablets, capsules, pellets, softgels and dripping pills in the fasted stomach
• Gastric stage of two-stage and transfer models (FaSSGF → FaSSIF / FeSSIF)
• IVIVC and biopharmaceutics classification support
🧪 Formulation & Stability Studies
• Solubility, wetting and precipitation of poorly soluble APIs
• Acid stability of drugs, prodrugs and lipid-based formulations
• Enteric coating, disintegration and capsule-shell performance
🦠 Nutraceuticals, Probiotics & Food
• Acid-tolerance and survival of probiotic strains
• Release of supplements and functional ingredients
• In vitro gastric digestion models
🎓 Research & Education
• Gastric physiology and drug-absorption research
• Teaching dissolution and biorelevant-media concepts
• Method development and inter-laboratory comparison
Typical Properties
- Appearance: Clear, colourless solution
• pH: 1.6 ± 0.1 at 25 °C
• Composition: Sodium chloride and hydrochloric acid with fasted-state concentrations of sodium taurocholate and lecithin, plus pepsin, in purified water (FaSSGF model)
• Enzyme: Pepsin (enzyme-free version on request)
• Sterility: 0.2 µm sterile-filtered
• Water Grade: ISO 3696 purified water
• Format: Ready-to-use liquid; Powder Version Kit on request
Storage, Shelf Life & Transportation
- Storage Temperature: 2–30 °C, protected from light; transportation at room temperature
• Shelf Life: 1 year (unopened)
• Enzyme Activity: Contains pepsin – best kept at 2–8 °C for prolonged storage and full enzyme activity; 2–30 °C is fine for short-term use and shipping. Avoid repeated freeze–thaw
• Preservative-Free Version: Available on request
• Powder Version Kit: 2-year shelf life, easy to reconstitute, suitable for culture-related applications – recommended when a preservative is not required
• After Opening: Handle aseptically; close tightly after use, do not return unused material to the container and use within the test series
Customization Options
- Customization available on request:
• Enzyme-free FaSSGF or alternative pepsin activity
• pH, bile salt / lecithin level and osmolality adjustment
• Fed-state (FeSSGF), species-specific (rat, canine) and paediatric versions
• Preservative-free version, Powder Version Kit, custom pack sizes and bulk supply
Frequently Asked Questions
What is the difference between FaSSGF and USP Simulated Gastric Fluid?
USP SGF is a simple pH 1.2 sodium chloride / HCl medium (with or without pepsin). FaSSGF is set at the fasted-state pH 1.6 and contains low, physiological levels of bile salt and lecithin as well as pepsin, which makes it more predictive for poorly soluble and lipid-based formulations.
How should the pepsin-containing medium be stored?
Store at 2–30 °C for routine use; for prolonged storage and full enzyme activity keep at 2–8 °C and avoid repeated freezing and thawing. The Powder Version Kit (2-year shelf life) is recommended when fresh medium without preservative is preferred.
Ordering Information
BZ379 is available in standard laboratory sizes or OEM/bulk supply formats.
📄 MSDS, Technical Datasheet, and Certificate of Analysis (CoA) available upon request
📧 Email: info@biochemazone.com
🌐 Website: www.biochemazone.com
⚠️ For research, education, and in vitro testing only. Not for human or animal use.
