USP Simulated Intestinal Fluid TS (SIF, pH 6.8) BZ575
Product Code: BZ575
Manufacturer: Biochemazone
Available Pack Sizes: 100 mL, 200 mL, 500 mL, 1 L (with pancreatin or without enzyme)
Custom Bulk Quantities Available
Product Overview
Biochemazone USP Simulated Intestinal Fluid TS BZ575 is prepared to the United States Pharmacopeia test solution “Intestinal Fluid, Simulated, TS”: a monobasic potassium phosphate buffer adjusted with sodium hydroxide to pH 6.8 ± 0.1, with pancreatin. It is the compendial medium for dissolution, disintegration and drug-release tests that call for simulated intestinal fluid.
Two versions are offered. With pancreatin follows the full USP TS composition (per litre: 6.8 g monobasic potassium phosphate, sodium hydroxide to pH 6.8 and 10.0 g pancreatin). Without enzyme is the same pH 6.8 phosphate buffer with the pancreatin left out, for methods that specify simulated intestinal fluid without enzyme and for buffer-stage testing of enteric-coated products.
Each batch is prepared with ISO 3696 compliant high-purity water under Biochemazone’s ISO 9001 / GMP quality system and checked for pH before release. For biorelevant media with bile salts see FaSSIF and FeSSIF.
Key Features & Benefits
✅ Prepared to USP TS – Composition of “Intestinal Fluid, Simulated, TS”
✅ pH 6.8 ± 0.1 – Checked on every batch
✅ Two Versions – With pancreatin (full TS) or without enzyme
✅ Flexible Storage – 2–30 °C for short-term use; enzyme version best kept at 2–8 °C
✅ ISO 3696 Grade Water – Prepared using high-purity laboratory water
✅ Ready-to-Use – No weighing or pH adjustment
✅ Consistent Batch-to-Batch – Reproducible medium for QC release testing
✅ Made in Canada – Manufactured under ISO 9001 / GMP quality systems
Applications
🧪 Compendial Dissolution & Disintegration
• Dissolution testing of tablets and capsules in SIF
• Buffer-stage testing of enteric-coated and delayed-release products
• Gelatin-capsule cross-linking investigations (with pancreatin)
💊 Formulation Development
• Release profiling of modified-release dosage forms
• Drug solubility and stability at intestinal pH
• Two-stage gastric-to-intestinal test sequences with SGF
🔬 Research
• In vitro digestion and digestibility assays
• Probiotic and supplement intestinal-survival studies
• Medical-device and material exposure to intestinal conditions
Usage Areas
- Pharmaceutical quality-control laboratories
- Formulation and analytical development laboratories
- Contract testing and research organisations
- Nutraceutical and supplement manufacturers
- Universities and food-safety laboratories
Typical Properties
- Appearance: Without enzyme – clear, colourless liquid; with pancreatin – slightly turbid, pale yellow liquid
- pH: 6.8 ± 0.1
- Composition (with pancreatin), per litre: 6.8 g monobasic potassium phosphate, sodium hydroxide to pH 6.8, 10.0 g pancreatin
- Composition (without enzyme): phosphate buffer only
- Water Grade: ISO 3696 purified water
Storage & Stability
- Storage Temperature: 2–30 °C
- Shelf Life: 1 year for unopened bottles
- Shipping: Room temperature
- Enzyme version (with pancreatin): best kept at 2–8 °C for prolonged storage and enzyme activity; storage at 2–30 °C is fine for short-term use
- Mix gently before use
Customization Options
- pH adjustment (for example pH 6.5 or 7.5)
- Pancreatin concentration to customer specification
- Sterile-filtered enzyme-free version
- Custom pack sizes and bulk / OEM supply
Ordering Information
BZ575 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 laboratory research and in vitro testing only. Not for human or animal use.
