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Levocarnitine, L‑Carnitine Base, Levo Carnitine, R-Carnitine, Vitamin BT, 541-15-1

Levocarnitine, L‑Carnitine Base, Levo Carnitine, R-Carnitine, Vitamin BT, 541-15-1

L-CARNITINE BASE (LEVOCARNITINE)

PRODUCT IDENTIFIER INFORMATION

Parameter Information
Product Name L-Carnitine Base (Levocarnitine)
Chemical Name (IUPAC) (R)-3-Hydroxy-4-(trimethylammonio)butanoate
CAS Number 541-15-1
EC Number (EINECS) 208-768-0
Molecular Formula C7H15NO3
Molecular Weight 161.20 g/mol

SECTION 1: CHEMICAL IDENTITY AND DESCRIPTION

Parameter Information
Chemical Name (IUPAC) (R)-3-Hydroxy-4-(trimethylammonio)butanoate
Synonyms L-Carnitine Base, Levocarnitine, Carnitine Base, Levo Carnitine, (R)-Carnitine, Vitamin BT
Trade Names Carnitor, Carniking, Levocarnit
CAS Number 541-15-1
EC Number (EINECS) 208-768-0
Molecular Formula C7H15NO3
Molecular Weight 161.20 g/mol
Chemical Class Amino acid-like compound (quaternary ammonium compound)
Pure L-Carnitine Content 100% (pure base; contains no salt or ester)
Physical State (20°C) Solid (white hygroscopic crystalline powder)
Odor Characteristic, sharp acidic
Taste Very acidic, unpleasant

SECTION 2: PHYSICAL AND CHEMICAL PROPERTIES

Property Value Test Method
Appearance White hygroscopic crystalline powder Visual
Odor Characteristic, sharp acidic Olfactometric
Taste Very acidic, unpleasant Sensory
Molecular Weight 161.20 g/mol Calculated
Melting Point 197 – 212°C (with decomposition) DSC
Specific Optical Rotation ([α]25D) -29° to -32° (c=1, H2O) Polarimetry
pH (1% solution, 25°C) ~3.0 (very acidic) pH Meter
Solubility in Water (25°C) Very freely soluble (>200 g/L) Gravimetric
Solubility in Ethanol Slightly soluble General Method
Solubility in Acetone Insoluble General Method
Hygroscopicity Very high; rapidly absorbs moisture from air, cakes Visual
Stability Stable under normal conditions; strictly protect from moisture  
Flash Point Non-flammable Not applicable

SECTION 3: CHEMICAL PROPERTIES AND REACTIVITY

Parameter Information
Chemical Character Zwitterionic structure (inner salt); both acidic and basic character
Stability Stable under normal conditions; highly hygroscopic
Decomposition Products (Heating) Above 200°C: CO, CO2, NOx, trimethylamine
Incompatible Materials Strong oxidizing agents, strong acids
Reaction with Acids Forms corresponding salts with acids (HCl, tartrate, fumarate salts)
Biological Role Reference molecule for fatty acid transport and mitochondrial oxidation
Hazardous Polymerization Does not occur

SECTION 4: L-CARNITINE FORMS COMPARISON

Property L-Carnitine Base L-Carnitine Tartrate Acetyl-L-Carnitine (ALCAR) Propionyl-L-Carnitine HCl L-Carnitine Fumarate
CAS Number 541-15-1 36687-82-8 3040-38-8 119793-66-7 90471-79-7
Molecular Weight 161.20 472.49 203.24 253.72 Variable
Pure L-Carnitine Content 100% ~67% ~80% ~74% ~58-62%
Bioavailability ~14-18% ~15-20% ~20% ~15% ~25-30%
Hygroscopicity Very High Low Medium Low Very Low
pH (1% solution) ~3.0 3.0-4.0 2.0-3.5 4.5-6.0 3.0-4.0
Gastric Tolerance Low (very acidic) Moderate Moderate Good Very Good
Tabletability Difficult Excellent Good Good Good
Cost Lowest Low Medium High Medium
Clinical Approval Yes (deficiency) No (supplement) Yes (neuropathy) Yes (PAD) Limited
Primary Use Deficiency, dialysis Sports, performance Brain, cognition Cardiovascular Energy, heart

SECTION 5: PHARMACOLOGICAL PROPERTIES AND MECHANISM OF ACTION

Property Description
Primary Function Transport of long-chain fatty acids across inner mitochondrial membrane
Mechanism of Action Essential cofactor for carnitine palmitoyltransferase (CPT) enzyme system
Mitochondrial Oxidation Required for β-oxidation of fatty acids; supports energy production
Endogenous Form Identical to naturally occurring carnitine in the body
Absorption Absorbed from small intestine via active transport (OCTN2) and passive diffusion
Bioavailability ~14-18% (oral); bioavailability decreases with increasing dose
Distribution Primarily stored in skeletal muscle and cardiac muscle
Elimination Excreted unchanged via kidneys; glomerular filtration + tubular reabsorption
Half-Life 2-15 hours (dose-dependent)

SECTION 6: PRIMARY APPLICATION AREAS

Sector / Application Use Typical Dosage
Clinical - Primary Carnitine Deficiency Genetic disorders, valproate therapy 50-100 mg/kg/day (3-4 divided doses)
Clinical - Hemodialysis Prevention of dialysis-related carnitine loss (FDA approved) 1-2 g IV post-dialysis or 2-3 g/day oral
Clinical - Heart Failure (NYHA II-III) Adjunctive therapy 1-2 g/day oral
Cardiovascular Post-myocardial infarction, angina 1-2 g/day
Male Infertility Improvement of sperm motility and quality 1 g/day (500 mg × 2)
Metabolic Syndrome / Type 2 Diabetes Improvement of insulin sensitivity 1-2 g/day
Sports Nutrition Fat burning, recovery (less preferred than tartrate) 1-2 g 60-90 min before exercise
General Energy / Fatigue Energy support 500-1000 mg/day

SECTION 7: QUALITY SPECIFICATIONS (PHARMACEUTICAL/FOOD GRADE)

Parameter Specification Test Method
Appearance White crystalline powder Visual
Odor Characteristic, sharp acidic Olfactometric
Purity (C7H15NO3, Dry Basis) 98.0 – 102.0% HPLC / Titrimetric
Specific Optical Rotation ([α]25D) -29° to -32° (c=1, H2O) Polarimetry
pH (1% solution, 25°C) 2.5 – 3.5 pH Meter
Loss on Drying (105°C, 2 hours) ≤ 1.0% Gravimetric
Ash Content ≤ 0.2% Gravimetric (600°C)
Heavy Metals (as Pb) ≤ 10 ppm ICP-MS
Lead (Pb) ≤ 2 ppm ICP-MS
Arsenic (As) ≤ 3 ppm ICP-MS
Mercury (Hg) ≤ 1 ppm ICP-MS
Cadmium (Cd) ≤ 1 ppm ICP-MS
Chloride (Cl-) ≤ 0.01% Argentometric
Sulfate (SO4 2-) ≤ 0.01% Turbidimetric
Related Substances (Total) ≤ 1.0% HPLC
Total Microbial Count ≤ 1,000 CFU/g USP <61>
Yeast and Mold ≤ 100 CFU/g USP <61>
E. coli Negative in 10g USP <62>
Salmonella spp. Negative in 25g USP <62>

SECTION 8: TOXICOLOGICAL PROFILE

Parameter Value
Acute Oral Toxicity (LD50, Rat) > 5,000 mg/kg (low toxicity)
Acute Dermal Toxicity (LD50, Rabbit) > 2,000 mg/kg
Skin Irritation Mild irritant (acidic nature)
Eye Irritation Irritant (acidic nature)
Respiratory Irritation Inhalation of dust may cause mechanical irritation
Carcinogenicity Not classified (IARC, NTP)
Mutagenicity Negative in in vitro tests
Reproductive Toxicity No known adverse effects
Side Effects High dose (>3 g/day): diarrhea, nausea, body odor (fishy odor)
GRAS Status Recognized as GRAS by FDA

SECTION 9: GHS CLASSIFICATION AND LABELING

GHS Classification (compliant with 1272/2008/EC):

Hazard Class Category H-Statement
Skin Irritation Category 2 H315
Eye Irritation Category 2 H319
Specific Target Organ Toxicity (STOT - SE) Category 3 H335

Signal Word: WARNING

Hazard Pictograms: GHS07 (Exclamation Mark)

Hazard Statements (H-Codes):

Code Statement
H315 Causes skin irritation
H319 Causes serious eye irritation
H335 May cause respiratory irritation

Precautionary Statements (P-Codes):

Code Statement
P261 Avoid breathing dust
P280 Wear protective gloves/eye protection
P302+P352 IF ON SKIN: Wash with plenty of water and soap
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes

SECTION 10: FIRST AID MEASURES

Exposure Route Action to Take
Inhalation Move to fresh air. Seek medical attention if respiratory irritation persists.
Skin Contact Wash with plenty of water and soap. Seek medical attention if irritation persists.
Eye Contact Rinse immediately with plenty of water for at least 15 minutes. Remove contact lenses if present. Seek medical attention.
Ingestion Rinse mouth with water. Drink plenty of water. Seek medical attention if you feel unwell.

SECTION 11: FIREFIGHTING MEASURES

Parameter Information
Fire Hazard Non-flammable
Hazards During Fire CO, CO2, NOx, trimethylamine
Suitable Extinguishing Media Water mist, CO2, dry chemical powder, foam
Special Protective Equipment Self-contained breathing apparatus (SCBA), full protective clothing

SECTION 12: STORAGE AND SHELF LIFE

Parameter Information
Storage Conditions Cool (15-25°C), dry, well-ventilated area; strictly protect from moisture
Container Requirements Tightly closed, airtight, moisture-proof containers
Keep Away From Moisture (very hygroscopic), direct sunlight, strong oxidizing agents
Shelf Life 24 months (unopened original packaging under appropriate storage conditions)
Stability Note Very hygroscopic; rapidly absorbs moisture from air and cakes; use immediately after opening

SECTION 13: PACKAGING OPTIONS

Packaging Type Quantity Material
Aluminum foil pouch (moisture-proof) 1 kg Laminated aluminum
Aluminum foil pouch (moisture-proof) 5 kg Laminated aluminum
Kraft bag with PE inner liner (moisture-proof) 25 kg Kraft paper + PE
Fiber drum (moisture-proof) 25-50 kg Fiberboard + PE

SECTION 14: TRANSPORTATION INFORMATION

Parameter Information
UN Number Not regulated (not hazardous)
Hazard Class Not applicable
Packing Group Not applicable
ADR/RID Not regulated
IMDG Code Not regulated
IATA (Air) Not regulated
Marine Pollutant No
Transport Temperature Ambient; strictly protect from moisture

SECTION 15: REGULATORY STATUS

Region / Authority Status
USA (FDA) Prescription drug (carnitine deficiency); GRAS as OTC supplement
European Union Permitted in food supplements and infant formula
USP-NF Official monograph (USP Levocarnitine)
European Pharmacopoeia Official monograph (Ph. Eur. Levocarnitine)
WHO Essential Medicines List Essential medicine (carnitine deficiency)
Turkey Licensed pharmaceutical active ingredient; food supplement
Halal / Kosher / Vegan Available

SECTION 16: OTHER NAMES AND SYNONYMS

Type Name
Chemical Names (R)-3-Hydroxy-4-(trimethylammonio)butanoate; (R)-Carnitine
Common Names L-Carnitine Base, Levocarnitine, L-Carnitine, Carnitine
Historical/Trade Names Vitamin BT, Carnitor, Carniking, Levocarnit
CAS Number 541-15-1
EC Number 208-768-0

SECTION 17: SUMMARY TABLE

Parameter Value
Product L-Carnitine Base (Levocarnitine)
CAS Number 541-15-1
Molecular Formula C7H15NO3
Molecular Weight 161.20 g/mol
Appearance White hygroscopic crystalline powder
pH (1% solution) ~3.0
Solubility in Water >200 g/L
Primary Function Fatty acid transport, mitochondrial energy, carnitine deficiency treatment
Shelf Life 24 months
GHS Signal Word Warning

SECTION 18: CRITICAL WARNINGS AND BEST PRACTICES

CRITICAL WARNINGS:

  1. Very Hygroscopic: Rapidly absorbs moisture from air and cakes. Store in airtight containers; use immediately after opening.

  2. Very Acidic (pH ~3.0): Taste is unpleasant; should be consumed mixed with fruit juice or sports drink.

  3. Gastric Sensitivity: In patients with gastric sensitivity, salt forms (tartrate, fumarate) should be preferred over the base form.

  4. Tableting Difficulty: Difficult to tablet due to high hygroscopicity; flowability issues occur.

  5. High Dose Side Effects: Doses >3 g/day may cause diarrhea, nausea, and rarely fishy body odor.

BEST PRACTICE RECOMMENDATIONS:

  1. Moisture Control: Maintain relative humidity below 30% in storage area; store with desiccants such as silica gel.

  2. Consumption: Consume powder form mixed with fruit juice or sports drink; taking on an empty stomach increases absorption.

  3. Encapsulation: Due to hygroscopic nature of powder, encapsulation process should be performed in controlled humidity environment.

  4. Alternative Selection: Carnitine Tartrate or Fumarate is more suitable for those wanting tablet/capsule form or those with gastric sensitivity.

  5. Storage: Store opened packaging in airtight containers in a dry environment and consume within a short time.

LEGAL DISCLAIMER:

The information provided in this document is presented in good faith based on our current knowledge and experience; however, since all usage conditions are beyond our control, it does not constitute a binding specification or warranty. This Technical Data Sheet is for informational purposes only and does not constitute medical advice. Users are obligated to test the suitability for their own applications. For complete safety, storage, handling, transportation, disposal, and regulatory compliance information, refer to the official Safety Data Sheet (SDS/MSDS) provided by the manufacturer/supplier. This product is not intended to diagnose, treat, cure, or prevent any disease.

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