Bilirubin Powder
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Product Introduction
Bilirubin Powder for Precision IVD Applications
Bilirubin Powder is a critical component in modern diagnostic systems, designed to ensure accuracy in jaundice detection calibrators and liver function tests. At sxytorganic.com, we produce USP/EP-grade powder with ≥99% purity, optimized for IVD applications requiring unmatched batch-to-batch consistency. Whether you’re formulating blood analyzer controls or calibrating jaundice detection calibrators, our product delivers reliable performance under strict regulatory standards.
Why Choose Our Bilirubin Powder?
Uncompromised Purity & Consistency
- USP/EP/CP Compliance: Meets global pharmacopeia standards, ensuring adherence to rigorous quality benchmarks set by the U.S. Pharmacopeia, European Pharmacopoeia, and Chinese Pharmacopoeia. This alignment guarantees consistent purity, potency, and safety across international markets, eliminating regulatory barriers for pharmaceutical formulations, nutraceuticals, and diagnostic reagents, making it suitable for global distribution in regions with strict pharmacopeial requirements.
- HPLC-Verified: ≤0.1% heavy metals, endotoxins ≤0.1 EU/mg, validated through high-performance liquid chromatography to confirm ultra-low impurity levels. These stringent specifications exceed industry standards, ensuring safety in parenteral drugs, neonatal supplements, and sensitive cell culture applications where heavy metals or endotoxins could trigger toxicity or skew experimental results.
- Light-Protected Packaging: Prevents degradation during storage/shipping with amber glass vials and UV-blocking foil wraps that shield sensitive compounds from photodegradation. This packaging maintains stability even during prolonged transit or exposure to fluorescent lighting in labs, preserving potency in light-sensitive products like vitamin formulations, diagnostic enzymes, or pharmaceutical intermediates.
Tailored for Diagnostic Accuracy
Our bilirubin powder ensures:
- Precise calibration of jaundice detection calibrators: Ensures accuracy within ±2% of target bilirubin levels, validated against NIST-traceable standards to align with clinical thresholds (2–20 mg/dL). This precision is critical for neonatal jaundice screening, where misreading can lead to under/over-treatment, and adult liver function tests, guaranteeing reliable bilirubin quantification across diverse detection platforms (spectrophotometers, point-of-care devices).
- Stable performance in hemolyzed blood simulations: Maintains consistent readings even in samples with hemoglobin levels up to 500 mg/dL, resisting interference from red blood cell breakdown—a common issue in pediatric and emergency settings. This stability ensures accurate bilirubin measurement in hemolyzed specimens, preventing false highs/lows that could compromise diagnosis of liver dysfunction or hemolytic disorders.
- Repeatable results across liver function assays: Delivers CV (coefficient of variation) <3% in inter-assay and intra-assay tests, ensuring consistency whether used in daily clinical runs or multi-center studies. This reliability supports longitudinal monitoring of patients with cirrhosis, hepatitis, or gallbladder disease, where consistent bilirubin tracking is key to assessing treatment response and disease progression.
Global Compliance, Local Agility
- Certified for ISO 13485, FDA 21 CFR Part 820, and CE-IVDR: Adheres to globally recognized quality management standards for medical devices, ensuring strict process controls from raw material sourcing to final packaging. ISO 13485 validates consistent quality, FDA 21 CFR Part 820 meets U.S. regulatory requirements, and CE-IVDR ensures compliance with EU in vitro diagnostic regulations, facilitating market access and instilling confidence in clinical labs worldwide.
- Cold-chain shipping to 100+ countries: Maintains product stability during transit with temperature-controlled packaging (2–8°C) monitored via GPS-enabled loggers, ensuring bilirubin calibrators remain within specification. This reliable logistics network covers remote clinics and major hospitals alike, with 48-hour delivery to key regions and 72-hour coverage for emerging markets, eliminating supply chain gaps for critical diagnostic tools.
Functions Of Bilirubin Powder
- Antioxidant: Bilirubin is a natural antioxidant in the human body that can remove free radicals and protect cell membranes, lipids and DNA from oxidative damage.
- Immunomodulation: Bilirubin can inhibit complement activation, reduce the release of proinflammatory factors, and relieve excessive inflammatory responses.
- Cardiovascular protection: Reduce the oxidation of low-density lipoprotein (LDL), inhibit the formation of arterial plaques; improve endothelial function and promote the release of nitric oxide.
- Participate in bile circulation metabolism: Bilirubin is an important pigment in bile, participates in bile circulation, promotes the secretion of bile, and helps digestion and absorption of fat.
- Maintain normal organ function: Bilirubin can play a certain protective role on the brain, heart, liver, etc., and help maintain the normal function of these organs.
Applications in IVD Systems
- Jaundice test calibrators: Ensure analyzer accuracy with pre-validated purity.
- Hemolysis Simulation: Mimic real-world blood samples for analyzer validation.
- Liver Function Reagents: Formulate stable assays with ≤0.5% moisture content.
Technical Specifications
Parameter | Detail |
---|---|
Purity | ≥99% (UV-Vis) |
Solubility | 0.1% NH₃·H₂O solution |
Storage | 2–8°C, protected from light |
CAS No. | 635-65-4 |
Certifications & Sustainability
- ISO 13485 | REACH | RoHS
- Ethically sourced, REACH-compliant raw materials.
Flexible Packaging Options
- R&D Samples: 1g/5g/10g vials.
- Bulk Orders: 100g–1kg GMP-grade containers.
- MOQ: 100g | Lead Time: 2–3 weeks.
Your Technical Partner
We provide:
- Free SDS, CoA, and solubility protocols.
- Stability data for FDA/CE submissions.
- 24/7 support for IVD integration.
FAQs
Q: How should I store the product for IVD use?
A: Keep sealed at 2–8°C. Our light-proof vials prevent photodegradation.
Q: Does purity affect Jaundice test calibrators accuracy?
A: Absolutely. ≥99% purity minimizes false positives in jaundice detection calibrators.
Q: Can you customize formulations?
A: Yes! Ask about blends with stabilizers for pH-sensitive assays.
Q: What certifications do you hold?
A: ISO 13485, FDA, and CE-IVDR—full documentation provided.
Ready to Optimize Your IVD Workflow?
Contact Us: Email sales@sxytorganic.com for bulk pricing or stability data.
Trusted by IVD leaders worldwide, our bilirubin powder combines scientific rigor with supply chain reliability. Let’s elevate your diagnostic accuracy together.