Shandong Huashang Chemical Co., Ltd. is a high-tech enterprise focused on industry of fine chemicals research and develop, produce and sale. Shandong Huashang Chemical Co., Ltd. is located in Shan Dong Ji Nan China. we have the ability to provide you high quality products. More than 90 % of our products are exported to developed countries and regions such as north America, Europe, Japan, South Korea and the Middle East.
Tacrolimus
1. Basic Information
Name: Tacrolimus
Alias: FK506, (3S,4R,5S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S)-5,6,12,14-Tetrahydroxy-3,4,5,6,9,10,11,12,13,14,21,22-dodecahydro-8-methoxy-3,4,10-trimethyl-23-(prop-2-en-1-yl)-1,7-dioxo-1,17-seco-3,19-cyclo-23,24-dinorhomo-1H-indo[3,2-c][1,4]oxaazacyclohenicosine-18-carboxylic acid
CAS No.: 104987-11-3
Molecular Formula: C44H69NO12
Molecular Weight: 804.02
Category: Macrolide immunosuppressant API, transplant anti-rejection drug raw material
2. Physical and Chemical Properties
Physical Properties
- Appearance: White to off-white crystalline powder
- Odor: Odorless
- Solubility: Soluble in methanol, ethanol, acetone, dichloromethane; slightly soluble in hexane; practically insoluble in water
- Melting Range: 113–115 ℃
- Hygroscopy: Slightly hygroscopic under high humidity
- Aqueous Property: Neutral macrolide, insoluble in water, stable in neutral organic solvents
Chemical Properties
- Molecular structure: Large polycyclic macrolide containing multiple hydroxyl, ether, ketone, double bond functional groups
- Hydroxyl reactivity: Hydroxyl groups can undergo acylation, silylation protection for derivative synthesis
- Double bond characteristics: Multiple conjugated double bonds, easy to oxidize under light and air
- Optical activity: Multiple chiral centers, high optical purity required for pharmaceutical use
- Thermal stability: Stable below 100 ℃; overheating triggers oxidation and decomposition to form related impurities
- Photostability: Highly light-sensitive; UV irradiation rapidly produces colored oxidative impurities
- Compatibility: Compatible with anhydrous polar organic solvents; incompatible with strong oxidants, concentrated strong acid/alkali
3. Main Application Fields
1. Organ Transplant Immunosuppressant API (Core Application)
Clinical core drug for kidney, liver, heart and other solid organ transplantation, inhibits T lymphocyte activity to reduce postoperative graft rejection; also used for refractory atopic dermatitis topical preparations
2. Immunology Research Reagent
Laboratory tool for immune cell signal pathway research, calcineurin inhibition mechanism study
3. Pharmacopoeia Reference Standard
HPLC standard for related substance and enantiomer detection in tacrolimus production quality control
4. Quality Specification Table
| Test Item | Standard Specification |
| CAS Number | 104987-11-3 |
| Molecular Formula | C44H69NO12 |
| Appearance | Uniform white crystalline powder without yellow/brown oxidation impurities |
| HPLC Purity | Pharma Grade ≥99.0% |
| Specific Optical Rotation [α]D20 | ?74° ~ ?84° (MeOH) |
| Water Content (KF) | ≤0.50% |
| Residue on Ignition | ≤0.10% |
| Single Maximum Unknown Impurity | ≤0.05% |
| Heavy Metals (Pb) | ≤10 ppm |
| Packaging | Nitrogen-filled amber vacuum aluminum foil bags / low-light PE lined fiber drums |
| Storage Condition | Hermetically sealed cool dry warehouse 2–8 ℃, full light shielding, isolate air and oxidants |
| Transportation Requirement | Cold-chain light-sensitive macrolide solid, moisture-proof & light-proof sealed packaging |
| Shelf Life | 36 months under nitrogen vacuum sealed low-temperature storage |
Safety Warning
Immunosuppressive toxic pharmaceutical powder. Dust irritates eyes, nasal tract and respiratory mucosa; skin absorption may affect immune function. All operations must be carried out in ventilated fume hood with dust-proof respirator and nitrile chemical-resistant gloves. Strict prescription controlled drug, arbitrary oral/skin use may cause infection, renal toxicity, hypertension and other side effects. Waste liquid neutralized before discharge; solid waste classified as high-risk pharmaceutical hazardous waste, disposed by licensed professional institutions.
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