JP Dissolution Test Fluids – 1st Fluid (pH 1.2) and 2nd Fluid (pH 6.8) BZ603
Product Code: BZ603
Manufacturer: Biochemazone
Available Pack Sizes: 1 L, 5 L, 10 L, 20 L
Custom Bulk Quantities Available
Product Overview
Biochemazone JP Dissolution Test Fluids BZ603 are the two standard media of the Japanese Pharmacopoeia (JP) dissolution and disintegration tests: the 1st Fluid for Dissolution Test (pH 1.2) and the 2nd Fluid for Dissolution Test (pH 6.8). They are used in Japan and across Asia for release testing, product comparisons and bioequivalence dissolution profiles.
The 1st Fluid is a sodium chloride and hydrochloric acid solution (2.0 g sodium chloride and 7.0 mL hydrochloric acid in 1000 mL) with a pH of about 1.2. The 2nd Fluid is a phosphate buffer at pH 6.8, prepared as the JP describes. Both are checked for pH on every batch and prepared with ISO 3696 compliant high-purity water under Biochemazone’s ISO 9001 / GMP quality system.
Because dissolution vessels use about 900 mL each, the fluids are supplied in 1 L bottles and 5, 10 and 20 L containers. Always confirm the requirements of the JP edition that applies to your product.
Key Features & Benefits
✅ Japanese Pharmacopoeia Media – 1st Fluid (pH 1.2) and 2nd Fluid (pH 6.8)
✅ pH Checked Every Batch – Recorded on the certificate
✅ Bulk Sizes – 1 L to 20 L for routine dissolution
✅ Degassing-Ready – Particle-free, filtered solution
✅ No Weighing or pH Adjustment – Saves analyst time
✅ ISO 3696 Grade Water – Prepared using high-purity laboratory water
✅ Consistent Batch-to-Batch – Reproducible dissolution results
✅ Made in Canada – Manufactured under ISO 9001 / GMP quality systems
Applications
💊 Dissolution & Disintegration
• JP dissolution tests at pH 1.2 and 6.8
• Disintegration tests using the JP fluids
• Enteric-coated product acid and buffer stages
🧪 Development & Registration
• Dissolution profiles for generic-product comparison
• Stability-study dissolution testing
• Method transfer between sites in Japan and Asia
🏭 Quality Control
• Routine batch-release testing
• Contract laboratory testing
Usage Areas
- Pharmaceutical QC laboratories in Japan, Korea and Asia
- Companies registering products in Japan
- Contract testing laboratories
- Generic-drug developers
- University pharmaceutics departments
Typical Properties
- Appearance: Clear, colourless liquid
- pH: 1st Fluid about 1.2; 2nd Fluid 6.8
- 1st Fluid composition: 2.0 g sodium chloride and 7.0 mL hydrochloric acid per 1000 mL
- 2nd Fluid composition: Phosphate buffer, pH 6.8
- Water Grade: ISO 3696 purified water; filtered
- Hazard: 1st Fluid is acidic – handle with gloves and eye protection
Storage & Stability
- Storage Temperature: 2–30 °C
- Shelf Life: 1 year for unopened bottles
- Shipping: Room temperature
- Degas before use as your dissolution method requires
Customization Options
- Other JP and USP buffer media
- Surfactant-containing media (for example with polysorbate 80 or SDS)
- Private-label and IBC bulk supply
Ordering Information
BZ603 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 testing only. Not for human or animal use.
