D-Chiro-Inositol is a bioactive stereoisomer functioning as an insulin sensitizer and secondary messenger in human glucose metabolism. Produced through advanced stereospecific biocatalytic conversion and water-based crystallization, this high-purity crystalline powder delivers exceptional chiral purity for advanced metabolic and reproductive health formulations. Engineered with optimized flowability and complete batch traceability, it enables supplement manufacturers to scale commercial production of targeted therapeutic capsules, tablets, and functional blends without excipient interference.
Key Specifications
|
Parameter |
Specification Standard |
Analytical Method |
|
CAS Number |
643-12-9 |
Reference Standard |
|
Molecular Formula |
C6H12O6 (Weight: 180.16 g/mol) |
Stoichiometric |
|
Assay (Dry Basis) |
>= 99.0% |
HPLC-RID |
|
Specific Optical Rotation |
+23.0 to +25.0 degrees (c=5, H2O) |
Polarimetry |
|
Loss on Drying |
<= 0.5% |
Gravimetric (105 degrees C, 3h) |
|
Residue on Ignition |
<= 0.1% |
Sulfated Ash |
|
Heavy Metals (ICP-MS) |
<= 0.1 ppm total |
Inductively Coupled Plasma |
|
Bacterial Endotoxins |
< 0.25 EU/mg |
Kinetic Turbidimetric |
|
Particle Size (D90) |
< 100 micrometers |
Laser Diffraction |
Chemical & Functional Profile
Stereospecific Configuration: Precise spatial orientation of six hydroxyl groups ensures optimal binding affinity for inositol phosphoglycan mediator pathways.
Insulin Signaling Action: Functions as a secondary messenger activating pyruvate dehydrogenase and glycogen synthase phosphatases.
Thermal Stability: Maintains structural integrity up to 220 degrees C, accommodating standard capsule and tablet manufacturing granulation temperatures.
Solubility Profile: Freely soluble in water (>= 50 mg/mL at 25 degrees C), ensuring uniform dispersion in liquid and solid dosage matrices.
Technical Focus & Manufacturing Control
Chiral Purity Control: Enantiomeric separation techniques guarantee zero contamination from inactive or interfering myo-inositol isomers.
Residual Solvent Elimination: Manufactured entirely via aqueous crystallization pathways, eliminating Class 1 and Class 2 residual solvent risks.
Direct Compression Optimization: Jet-milled particle distribution prevents powder segregation and capping during high-speed rotary press operations.
Formulation & Application Considerations
Excipient Compatibility: Inert profile allows stable co-formulation with botanical extracts, amino acids, and standard binders like microcrystalline cellulose.
Hygroscopic Behavior: Exhibits low moisture absorption kinetics; maintains free-flowing characteristics under standard ambient warehouse conditions.
PH Stability Range: Stable across aqueous solutions ranging from pH 4.0 to 8.0, preventing active degradation in liquid matrix formats.
Bioavailability Enhancement: Fine particle morphology accelerates dissolution rate in simulated gastric fluid, supporting rapid systemic absorption.
Target Applications
PCOS Dietary Supplements: Active core ingredient for targeted female reproductive health and ovulation support capsules.
Insulin Resistance Formulations: Metabolic health tablets designed to support normal blood glucose disposal and cellular sensitivity.
Functional Powder Blends: Instantized drink mixes and wellness sachets requiring clean taste profiles and rapid dispersion.
Pharmaceutical Intermediates: Chiral starting material utilized in complex synthetic pathways for metabolic regulators.
Quality Assurance & Testing
Chromatographic Verification: Quantified via high-performance liquid chromatography coupled with refractive index detection to confirm assay values.
Microbial Enumeration: Total aerobic microbial count < 1000 CFU/g, with yeast, mold, and pathogenic organisms strictly absent.
Batch Retain Program: Representative samples from every commercial production lot are archived under controlled conditions for five years.
Storage & Stability
Storage Environment: Store in tightly sealed containers in a cool, dry, well-ventilated area away from direct sunlight and moisture.
Temperature Control: Maintain ambient warehouse temperatures between 15 degrees C and 25 degrees C.
Shelf Life: 24 months from the date of manufacture when kept in original unopened packaging.
Documentation & Regulatory Compliance
We offer complete Technical Dossiers containing:
Certificates of Analysis (COA): Representing registration, pilot, and commercial validation batches.
Material Safety Data Sheets (MSDS): Fully compliant with the latest GHS standards.
Technical Information: Product Specifications (TDS), Method of Analysis (MOA), and Route of Synthesis (ROS).
Regulatory Declarations: BSE/TSE-Free Certificates, Non-GMO Declarations, and Allergen Statements.
DMF & CEP Support: For core strategic APIs, we coordinate with partner manufacturers who maintain active Drug Master Files (DMF) or Certificates of Suitability (CEP) in highly regulated territories (such as US FDA, European EMA, and Japanese PMDA).
Packaging & Logistics
Primary Packaging: Food-grade dual-layer low-density polyethylene bags heat-sealed to prevent moisture ingress.
Secondary Packaging: Rigid fiber drums equipped with tamper-evident security seals.
Standard Net Weight: 25 kg per drum, with custom sampling quantities available upon request.
Transport Conditions: Non-hazardous chemical classification; compatible with standard ocean, air, and overland freight logistics.
Frequently Asked Questions
Q: What differentiates D-Chiro-Inositol from myo-inositol in formulations?
A: D-Chiro-Inositol acts directly as a specific insulin mediator involved in epimerase conversion, whereas myo-inositol serves as its biological precursor. Formulators frequently combine or deploy them based on targeted metabolic pathways.
Q: Does the manufacturing process utilize organic chemical solvents?
A: No. Purification relies entirely on water-based enzymatic conversion and fractional crystallization, ensuring a solvent-free chemical profile.
Q: What documentation verifies chiral purity?
A: Every batch ships with a dedicated Certificate of Analysis containing verified specific optical rotation values and chiral HPLC chromatogram data.
Q: What is the standard minimum order quantity for commercial evaluation?
A: Standard laboratory evaluation sample sizes begin at 100 g, with commercial bulk orders starting from one standard 25 kg drum.
Q: How does particle size impact direct compression tableting?
A: The controlled D90 < 100 micrometer particle distribution provides uniform compaction density, preventing capping and weight variation during high-speed production runs.
Hot Tags: d-chiro-inositol, China d-chiro-inositol manufacturers, suppliers, factory, CAS 106650 56 0, Cetilistat API, GLP 1 Protected Peptide Fragment, phenolphthalein pure powder, Sibutramine Hydrochloride Raw Material, Sibutramine powder
