Bilirubin API (Pharmaceutical Grade)

 High-Purity Bilirubin Raw Material Manufacturer

What is Bilirubin?

Bilirubin is a naturally occurring bile pigment generated during the degradation of heme in red blood cells. As an important biochemical compound, bilirubin is widely used in pharmaceutical research, in vitro diagnostic (IVD) reagent development, analytical laboratories, biochemical studies, and reference standard preparation.

MiSo Bio supplies high-quality pharmaceutical-grade bilirubin manufactured under a strict quality management system. Every production batch is tested according to the Chinese Pharmacopoeia (2025 Edition) and internal quality specifications to ensure high purity, low impurity levels, and excellent batch-to-batch consistency.

Whether you are developing diagnostic reagents, conducting biomedical research, or manufacturing pharmaceutical products, our bilirubin provides reliable quality supported by comprehensive analytical documentation.

Key Features

 Complies with the Chinese Pharmacopoeia (2025 Edition)

 Assay: ≥92.0% (Current batch: 100.9%)

 Loss on drying: 0.10%

 Total impurities: 0.64%

 Largest single impurity: 0.18%

 DMSO residue: 0.04%

 Host Cell Protein (HCP): 56.3 ng/mg

 Host Cell DNA: <3 pg/mg

 Microbial limits comply with pharmacopoeial requirements

 Batch-specific COA and quality documents available

The tested batch meets all specification requirements according to the Chinese Pharmacopoeia (2025 Edition) and internal quality standards. 

Typical Applications

 Pharmaceutical Research

 In Vitro Diagnostic (IVD) Reagents

 Biochemical Research

 Analytical Laboratories

 Reference Standards

Key Specifications

Applications

Our Bilirubin is suitable for:

 Pharmaceutical Research

Used in drug discovery and biochemical studies involving bilirubin metabolism and liver function.

 In Vitro Diagnostics (IVD)

Applied in bilirubin calibration standards, quality controls, and diagnostic reagent development.

 Clinical Laboratory Research

Suitable for analytical laboratories and reference laboratories.

 Biotechnology Research

Used for biochemical assays and biomarker research.

 Reference Standards

Can be used for laboratory validation and analytical method development.

Manufacturing & Quality Control

Quality is the foundation of pharmaceutical raw materials.

Every batch of Bilirubin undergoes comprehensive quality testing, including:

 Appearance Identification

 UV Identification

 HPLC Identification

 Assay

 Related Substances

 Residual Solvents

 Loss on Drying

 Host Cell Protein

 Host Cell DNA

 Microbial Limits

All testing is performed according to the Chinese Pharmacopoeia (2025 Edition) and internal quality standards to ensure product consistency and reliability.

Certificates & Compliance

Available Documentation

✔ Certificate of Analysis (COA)

✔ Quality Inspection Report

✔ MSDS / SDS

✔ Technical Data Sheet (TDS)

✔ Batch Traceability

✔ Chinese Pharmacopoeia Compliance

Additional documentation can be provided upon request.

Frequently Asked Questions

 What is Bilirubin?

Bilirubin is a natural bile pigment produced during the breakdown of hemoglobin.

 What is your assay?

Our specification requires not less than 92.0%. The tested batch reached 100.9%.

 What industries use Bilirubin?

 Pharmaceutical

 IVD

 Biotechnology

 Academic Research

 Do you provide COA?

Yes.Each production batch is supplied with a Certificate of Analysis.

 What analytical methods are used?

UV 

HPLC 

Microbiology

Residual Solvents

Host Cell Protein 

Host Cell DNA

 What packaging is available?

5 g (current specification) 

Customized packaging is available upon request.

 How should Bilirubin be stored?

Store in a cool, dry place away from light and moisture.

 What is the shelf life?

36 months under recommended storage conditions.

 Can you provide customized quantities?

Yes.We support laboratory, pilot-scale, and commercial quantities.

 Do you support global shipping?

Yes. We support international shipment according to customer requirements.