CERAMIDE NP

Ceramide NP (N-stearoyl-phytosphingosine, a phytoceramide often referred to as Ceramide 3) is a skin-identical sphingolipid widely used in topical formulations to restore the stratum corneum lipid matrix, improve barrier function, and enhance skin hydration. 
This article reviews chemical identity and structure, physical/chemical properties, biological role in skin physiology, mechanisms of action in topical care, formulation and stability concerns, analytical methods for identification and quantification, efficacy evidence from in-vitro and clinical studies, manufacturing approaches and sources, regulatory/safety assessments, alternatives and comparative agents, and practical considerations for formulators and researchers. Key knowledge gaps and future research directions are proposed.
Reported CAS numbers (appearing in different databases / suppliers): 34354-88-6 (N-Stearoyl-phytosphingosine).
Several supplier and product listings also report 178436-06-1 or other registry numbers depending on exact stereochemistry, salt/formulation or vendor product codes — this mismatch arises because “Ceramide NP” is an INCI/trade name that may map to closely related ceramide species and stereoisomers. 
Cite examples: Sigma/Aldrich and supplier pages list 34354-88-6; ChemicalBook and ChemSpider records also list 178436-06-1 for formulations labeled “Ceramide NP.” 

Representative synonyms / alternate names: N-Stearoyl-phytosphingosine; Ceramide 3; Ceramide III; C18 phytoceramide; N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]octadecanamide; D-ribo-1,3,4-trihydroxy-2-octadecanoylamidooctadecane (supplier synonyms vary).

Ceramides were first recognized as essential structural lipids within the stratum corneum — the outermost layer of the epidermis — and quickly became a focus of dermatological and cosmetic research because of their fundamental role in barrier function and transepidermal water loss (TEWL). 
Among the ceramide classes, the phytosphingosine-based ceramides (often labelled Ceramide NP / Ceramide 3) mimic the human skin’s native lipid composition and therefore were adapted into topical formulations to repair damaged barriers and improve hydration. 
The cosmetic and dermato-pharmaceutical industries adopted INCI names such as Ceramide NP to refer to N-acyl-phytosphingosine species used in products. 

Chemical identity, structure and stereochemistry
Molecular description
Core scaffold: sphingoid base (phytosphingosine) backbone (a trihydroxy long-chain base) N-acylated with a saturated C18 fatty acid (stearic acid) → N-stearoyl-phytosphingosine. 
This yields a molecule with one amide, multiple hydroxyl groups, and a long-chain hydrophobic tail — classical amphipathic ceramide structure. 

Formula, mass and registry

Representative molecular formula commonly reported for ceramide NP-type structures: approx C36H71NO4 (vendor and database dependent). 
Molecular mass values vary slightly by exact stereochemistry (e.g., 583.97 g·mol⁻¹ cited for some N-stearoyl-phytosphingosine listings). 

Stereochemistry and isomerism
Phytosphingosine has chiral centers (stereochemistry affects physical properties and biological recognition). 
Commercial “ceramide NP” materials may be single stereoisomers or mixtures; suppliers typically specify stereochemical purity or analytical characterization in product data sheets. This explains discrepancies in registry numbers across vendors. 
ABITEC, Larodan Research Grade Lipids

Physical and chemical properties
Physical form: typically a waxy solid or viscous lipid at room temperature depending on purity and formulation.
Solubility: highly lipophilic; practically insoluble in water; soluble in organic solvents and compatible with oil phases and certain emulsifiers. 
For incorporation into aqueous creams, ceramides are dispersed using appropriate solvents, melt-inclusion steps, or delivered in lamellar lipid systems. 

Thermal behavior: melting point depends on purity and chain packing; vendor technical sheets report melting/crystallization behavior important for formulation. 

Biochemical role and mechanism of action in skin
Role in epidermal barrier
Ceramides are major structural lipids (~50% by mass of stratum corneum lipids by some measures) that form lamellar bilayers between corneocytes, crucial for reducing TEWL and protecting against environmental insults. 
Phytosphingosine-based ceramides (Ceramide NP) closely resemble endogenous human skin ceramides and integrate into the lipid lamellae, restoring correct lipid ordering and barrier properties. 

Mechanisms when applied topically
Lamellar repletion: exogenous ceramide NP intercalates into disrupted stratum corneum lipid layers and helps recreate the lamellar architecture.
Hydration: by reconstituting the barrier, it decreases TEWL and indirectly improves stratum corneum hydration.
Anti-inflammatory / signaling: phytosphingosine derivatives are implicated in modulating signaling pathways and may exert anti-inflammatory or calming effects on irritated skin (some preclinical data suggest modulation of cytokine expression). 

Evidence of efficacy — in vitro, ex vivo, and clinical data
In vitro / cell studies
Studies show phytoceramides can affect keratinocyte differentiation markers and lipid metabolism enzymes, and have protective roles against barrier-disrupting agents in reconstructed epidermis models. 
Vendor application notes and peer-reviewed literature document barrier restoration in model systems. 

Ex vivo / human skin models
Ex vivo human skin and reconstructed epidermis studies demonstrate improved lamellar structure and decreased permeability when ceramide NP or ceramide-containing formulations are applied. 

Clinical studies

Multiple cosmetic/dermatology trials report improvements in dryness, scaling, and transepidermal water loss with ceramide-containing creams; Ceramide NP as a skin-identical ceramide is commonly included in such trials. 
Safety and tolerability are generally favorable in the concentrations used in cosmetic practice. Regulatory panels (e.g., Cosmetic Ingredient Review) have assessed ceramide ingredients and reported safety conclusions under current use practices. 

Formulation science — incorporation, delivery systems, and stability
Typical formulation strategies
Oil phase inclusion / melt-cool method: ceramides are often dispersed in the oil phase, heated to melt and then emulsified into water to form creams.

Lamellar liquid crystal systems / bicontinuous emulsions: to mimic native lipid lamellae, formulators use lamellar phase emulsions or liposomes to deliver ceramides into the stratum corneum more effectively.
Pro-ceramide systems: combinations with cholesterol and free fatty acids recreate the natural lipid ratio (ceramide:cholesterol:FFA) to maximize barrier repair. 

Stability issues
Ceramides are relatively chemically stable compared with some unsaturated lipids, but formulations must control hydrolytic and oxidative stresses (moisture, extreme pH, high temperatures). 
Proper surfactant choice and antioxidants may be used; supplier technical data give recommended storage and process parameters. 

Analytical methods for identification and quantification
Chromatography: HPLC (normal phase or reversed phase), often coupled with evaporative light scattering detection (ELSD) or MS detection, is used for separation and quantification.
Mass spectrometry: LC-MS/MS is the gold standard for detailed molecular identification, distinguishing chain lengths, saturation, and stereochemistry.
NMR & IR: used for structural confirmation and stereochemical assessment in research/manufacturing QC.
Vendors provide validated analytical methods for lot release and purity testing; research groups publish lipidomics methods for ceramide profiling in skin.

SAFETY INFORMATION ABOUT CERAMIDE NP

First aid measures:
Description of first aid measures:
General advice:
Consult a physician. 
Show this safety data sheet to the doctor in attendance.
Move out of dangerous area:
 
If inhaled:
If breathed in, move person into fresh air. 
If not breathing, give artificial respiration.
Consult a physician.
In case of skin contact:
Take off contaminated clothing and shoes immediately. 
Wash off with soap and plenty of water.
Consult a physician.
 
In case of eye contact:
Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.
Continue rinsing eyes during transport to hospital.
 
If swallowed:
Do NOT induce vomiting. 
Never give anything by mouth to an unconscious person. 
Rinse mouth with water. 
Consult a physician.
 
Firefighting measures:
Extinguishing media:
Suitable extinguishing media:
Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Special hazards arising from the substance or mixture
Carbon oxides, Nitrogen oxides (NOx), Hydrogen chloride gas
 
Advice for firefighters:
Wear self-contained breathing apparatus for firefighting if necessary.
Accidental release measures:
Personal precautions, protective equipment and emergency procedures
Use personal protective equipment. 
 
Avoid breathing vapours, mist or gas. 
Evacuate personnel to safe areas.
 
Environmental precautions:
Prevent further leakage or spillage if safe to do so.
Do not let product enter drains.
Discharge into the environment must be avoided.
 
Methods and materials for containment and cleaning up:
Soak up with inert absorbent material and dispose of as hazardous waste. 
Keep in suitable, closed containers for disposal.
 
Handling and storage:
Precautions for safe handling:
Avoid inhalation of vapour or mist.
 
Conditions for safe storage, including any incompatibilities:
Keep container tightly closed in a dry and well-ventilated place. 
Containers which are opened must be carefully resealed and kept upright to prevent leakage.
Storage class (TRGS 510): 8A: Combustible, corrosive hazardous materials
 
Exposure controls/personal protection:
Control parameters:
Components with workplace control parameters
Contains no substances with occupational exposure limit values.
Exposure controls:
Appropriate engineering controls:
Handle in accordance with good industrial hygiene and safety practice.
Wash hands before breaks and at the end of workday.
 
Personal protective equipment:
Eye/face protection:
Tightly fitting safety goggles. 
Faceshield (8-inch minimum). 
Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).
 
Skin protection:
Handle with gloves. 
Gloves must be inspected prior to use. 
Use proper glove
removal technique (without touching glove's outer surface) to avoid skin contact with this product. 
Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. 
Wash and dry hands.
 
Full contact:
Material: Nitrile rubber
Minimum layer thickness: 0.11 mm
Break through time: 480 min
Material tested:Dermatril (KCL 740 / Aldrich Z677272, Size M)
Splash contact
Material: Nitrile rubber
Minimum layer thickness: 0.11 mm
Break through time: 480 min
Material tested:Dermatril (KCL 740 / Aldrich Z677272, Size M)
It should not be construed as offering an approval for any specific use scenario.
 
Body Protection:
Complete suit protecting against chemicals, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.
Respiratory protection:
Where risk assessment shows air-purifying respirators are appropriate use a fullface respirator with multi-purpose combination (US) or type ABEK (EN 14387) respirator cartridges as a backup to engineering controls. 
 
If the respirator is the sole means of protection, use a full-face supplied air respirator. 
Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).
Control of environmental exposure
Prevent further leakage or spillage if safe to do so. 
Do not let product enter drains.
Discharge into the environment must be avoided.
 
Stability and reactivity:
Chemical stability:
Stable under recommended storage conditions.
Incompatible materials:
Strong oxidizing agents:
Hazardous decomposition products:
Hazardous decomposition products formed under fire conditions. 
Carbon oxides, Nitrogen oxides (NOx), Hydrogen chloride gas.
 
Disposal considerations:
Waste treatment methods:
Product:
Offer surplus and non-recyclable solutions to a licensed disposal company. 
Contact a licensed professional waste disposal service to dispose of this material.
Contaminated packaging:
Dispose of as unused product