VITAMIN D3 (CHOLECALCIFEROL)

1. CHEMICAL IDENTITY AND DEFINITION

Parameter	Information
Chemical Name	Cholecalciferol
Other Names	Vitamin D3, Colecalciferol, Calciol
CAS Number	67-97-0
E Number	E671
Chemical Formula	C₂₇H₄₄O
Molecular Weight	384.638 g/mol
Density	1.0 ± 0.1 g/cm³
Boiling Point	496.4 ± 24.0 °C (at 760 mmHg)
Melting Point	83 – 87 °C
Appearance	White to off-white crystalline powder
Odor	Odorless or slight characteristic odor
Solubility	Soluble in fats, oils, and organic solvents; insoluble in water
Vitamin Class	Fat-soluble vitamin

2. PHYSICAL AND CHEMICAL PROPERTIES

Property	Value
Appearance	White to off-white crystalline powder
Chemical Formula	C₂₇H₄₄O
Molecular Weight	384.638 g/mol
CAS Number	67-97-0
Density	1.0 ± 0.1 g/cm³
Melting Point	83 – 87 °C
Boiling Point	496.4 ± 24.0 °C
Flash Point	> 200 °C
Solubility in Water	Insoluble
Solubility in Fats/Oils	Soluble
Solubility in Ethanol	Soluble
Solubility in Acetone	Soluble
Optical Rotation [α]₂₀D	+82° to +88°
Stability	Sensitive to light, heat, and oxygen
Storage	Protected from light, inert atmosphere

3. CHEMICAL STRUCTURE

Chemical Structure:

Vitamin D3 is a secosteroid, meaning one of the rings in the steroid structure is broken. It is formed from 7-dehydrocholesterol upon exposure to UVB radiation.

IUPAC Name: (5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3β-ol

SMILES: CC(C)CCCC(C)C1CCC2C1(CCCC2=CC3=CC(CCC3=C)O)C

                    CH₃
                     |
              H₃C — CH — CH₂ — CH₂ — CH₂ — CH — CH₃
                     |                 |
                     |    CH₃         |
        HO — C — C — C — C — C — C — C — C — C — CH₂
             |   |   |   |   |   |   |   |
             H   H   H   H   H   H   H   CH₃

4. BIOSYNTHESIS AND METABOLISM

Step	Description
1. Precursor	7-dehydrocholesterol in skin
2. UVB Radiation	Sunlight (290-315 nm) converts precursor
3. Pre-Vitamin D3	Unstable intermediate
4. Thermal Isomerization	Body heat converts to Vitamin D3
5. Liver	25-hydroxylation to 25-hydroxyvitamin D (calcidiol)
6. Kidney	1α-hydroxylation to 1,25-dihydroxyvitamin D (calcitriol – active form)

5. BIOLOGICAL ROLE AND FUNCTIONS

Function	Description
Calcium Absorption	Enhances intestinal calcium absorption
Phosphorus Absorption	Promotes phosphorus uptake in the gut
Bone Health	Essential for bone mineralization and remodeling
Immune System	Modulates immune response; supports defense against infections
Muscle Function	Supports muscle strength and coordination
Cell Differentiation	Regulates cell growth and differentiation
Cardiovascular Health	May support heart health and blood pressure regulation
Mental Health	Role in mood regulation and cognitive function

6. HEALTH BENEFITS

Benefit	Description	Evidence Level
Bone Health	Strengthens bones; reduces osteoporosis risk	Strong clinical evidence
Rickets Prevention	Prevents rickets in children	Historical/clinical evidence
Immune Support	Regulates immune function	Clinical studies
Blood Pressure	May reduce blood pressure	Mixed evidence
Insulin Control	Contributes to insulin sensitivity	Emerging evidence
Anticancer Potential	May have protective effects against some cancers	Epidemiological evidence
Multiple Sclerosis	May reduce MS risk	Observational studies
Mood Regulation	Supports mood and may reduce depression risk	Clinical studies

7. DEFICIENCY SYMPTOMS

Symptom	Description
Fatigue	Persistent tiredness and weakness
Muscle Pain	Generalized muscle aches and weakness
Walking Difficulty	Due to muscle weakness and pain
Insomnia	Sleep disturbances
Depression	Mood changes, low mood
Hair Loss	Excessive hair shedding
Headaches	Frequent or chronic headaches
Cold Intolerance	Feeling cold constantly
Excessive Sweating	Particularly on the head
Tingling	In hands and feet
Under-Eye Dark Circles	Dark circles around eyes

Reference Range: 20 – 50 ng/mL
Deficiency Threshold: < 12 ng/mL

8. NATURAL SOURCES

8.1. Animal Sources

Source	Content (IU/100g)
Cod Liver Oil	10,000 – 20,000
Salmon	500 – 800
Sardines	300 – 500
Tuna	200 – 400
Trout	300 – 500
Beef Liver	50 – 100
Egg Yolk	40 – 60
Butter	30 – 50
Cheese	10 – 40
Milk	2 – 4

8.2. Sunlight

Factor	Description
Source	UVB radiation (290-315 nm)
Synthesis	Skin 7-dehydrocholesterol → Vitamin D3
Factors	Time of day, season, latitude, skin pigmentation, sunscreen use, age

9. RISK GROUPS

Group	Reason
Elderly Individuals	Reduced synthesis capacity and dietary intake
Dark Skin Individuals	Reduced UVB absorption due to melanin
Indoor Workers	Limited sun exposure
Northern Latitudes	Limited UVB during winter months
Breastfed Infants	Low vitamin D content in breast milk
Obese Individuals	Sequestration in adipose tissue
Malabsorption Patients	Intestinal disorders, celiac disease, Crohn's disease
Liver/Kidney Disease Patients	Impaired activation

10. DAILY REQUIREMENT

Age Group	Daily Requirement (IU)
0-12 months	400 IU
1-18 years	600 IU
19-70 years	600 IU
71+ years	800 IU
Pregnancy	600 IU
Breastfeeding	600 IU

Note: Some authorities recommend higher doses (800-2000 IU/day) for optimal health.

11. DOSAGE AND ADMINISTRATION

Application	Dosage	Form
Maintenance (Healthy Adults)	400 – 800 IU/day	Tablets, capsules, drops
Mild Deficiency	1,000 – 2,000 IU/day	Tablets, capsules
Moderate Deficiency	2,000 – 5,000 IU/day	Tablets, capsules
Severe Deficiency	5,000 – 10,000 IU/day	Under medical supervision
Infant Formula	200 – 400 IU/serving	Fortified formula
Fortified Dairy	100 – 200 IU/100 mL	Fortified milk, yogurt
Animal Feed (Poultry)	1,000 – 2,000 IU/kg	Feed additive
Animal Feed (Aquaculture)	500 – 1,000 IU/kg	Feed additive

12. SAFETY AND TOXICITY

Parameter	Information
Toxicity	Rare; only at extremely high doses
Oral LD50 (Rat)	> 10,000 mg/kg
Upper Tolerable Intake Level (UL)	4,000 IU/day (adults)
Hypervitaminosis D Symptoms	Nausea, vomiting, constipation, weight loss, kidney stones, cardiac arrhythmias
Drug Interactions	Thiazide diuretics, digitalis, corticosteroids, cholestyramine
Pregnancy	Safe at recommended doses
Breastfeeding	Safe at recommended doses

13. SECTOR APPLICATION TABLE

Sector / Application	Suitability	Typical Usage Rates	Notes / Regulations
Food & Nutrition	High suitability	Infant formula: 200–400 IU/serving; Fortified dairy: 100–200 IU/100 mL	EFSA, FDA GRAS approval required. Oil powder form preferred for infant formula.
Animal Feed	Suitable	Poultry feed: 1,000–2,000 IU/kg; Aquaculture: 500–1,000 IU/kg	Must comply with feed additive regulations. Often combined with A and E vitamins.
Pharmaceuticals	Core use	Tablets/capsules: 400–2,000 IU/day; Injection forms variable	GMP compliance mandatory. Used in osteoporosis, rickets, and immune support therapies.
Cosmetics	Limited	Trace amounts in creams/lotions (<0.1%)	Skin health claims limited; regulatory restrictions apply.
Chemical / Industrial	Not suitable	–	No industrial chemical application; only nutritional and medical purposes.

14. FORMS AND FORMULATIONS

Form	Description	Applications
Crystalline Powder	Pure vitamin D3	Pharmaceutical, supplement manufacturing
Oil Solution	Dissolved in vegetable oil	Liquid drops, softgels
Dry Powder	Encapsulated in starch or gum	Food fortification, feed additive
Emulsion	Water-dispersible	Beverage fortification
Spray Dried	Microencapsulated	Stable formulations
Beadlets	Gelled starch matrix	Feed additive

15. STORAGE AND HANDLING

Parameter	Information
Storage Conditions	Cool (15-25°C), dry, protected from light
Container Requirements	Tightly closed, light-protected, inert atmosphere
Protect From	Light, heat, oxygen, strong oxidizing agents
Shelf Life	12-24 months (with proper storage)
Stability	Sensitive to light, heat, and oxygen

16. REGULATORY STATUS

Region / Authority	Status
European Union (EFSA)	Approved as food supplement; E671
USA (FDA)	GRAS (21 CFR 184.1950)
Codex Alimentarius	Approved for food supplements and fortification
Turkey	Approved as food supplement
Australia (FSANZ)	Approved for food fortification
China	Approved for food supplements

17. OTHER NAMES AND SYNONYMS

Type	Name
Turkish Names	D3 Vitamini, Kolekalsiferol
English Names	Vitamin D3, Cholecalciferol, Colecalciferol, Calciol
E Number	E671
CAS Number	67-97-0

18. SUMMARY AND CRITICAL WARNINGS

Parameter	Value
Product	Vitamin D3 (Cholecalciferol)
CAS Number	67-97-0
Formula	C₂₇H₄₄O
Molecular Weight	384.638 g/mol
Appearance	White to off-white crystalline powder
Primary Function	Calcium/phosphorus metabolism, bone health, immune function

CRITICAL WARNINGS

1. FAT-SOLUBLE: Vitamin D3 is fat-soluble. It must be taken with dietary fat for optimal absorption.

2. SUNLIGHT SYNTHESIS: The body synthesizes vitamin D3 naturally through UVB exposure. Sunscreen and clothing reduce synthesis.

3. TOXICITY: Hypervitaminosis D is rare but serious. Doses above 4,000 IU/day should be taken under medical supervision.

4. STORAGE: Sensitive to light, heat, and oxygen. Store in light-protected containers with inert atmosphere.

5. DRUG INTERACTIONS: Thiazide diuretics, digitalis, corticosteroids, and cholestyramine may interact. Consult a healthcare professional.

6. REGULATORY COMPLIANCE: Must comply with EFSA, FDA, and Codex standards. Supplier documentation must include CAS number and certificate of analysis.

7. SUPPLEMENTATION: Deficiency is common in northern latitudes and among elderly. Routine supplementation may be beneficial.

8. FORTIFICATION: Commonly used in infant formula, dairy products, and cereal fortification.

9. COMBINATION: Often combined with Vitamin A and E in formulations.

10. LAB TESTING: Standard levels are measured as 25-hydroxyvitamin D. Deficiency threshold is <12 ng/mL; optimal is 20-50 ng/mL.

IMPORTANT DISCLAIMER: This Technical Data Sheet (TDS) is for informational purposes only and is prepared based on available technical data. This document is not a substitute for medical advice. For any health condition or suspected deficiency, consult a healthcare professional. For complete safety, storage, use, and regulatory compliance information, refer to the official documentation provided by the manufacturer/supplier.

Cholecalciferol, Vitamin D3, Colecalciferol, Calciol, E671, 67-97-0