MATRICARIA OILY EXTRACT

Botanical and Pharmacognostic Profile
Macromorphology: Annual herb (15–60 cm). Capitula with yellow tubular florets and white ray florets; hollow receptacle characteristic of Matricaria recutita (vs solid in Chamaemelum nobile).
Microscopy (powdered drug): Fragments of ligulate and tubular corollae, secretory canals; sesquiterpene‑bearing glandular trichomes; pollen grains ~22–28 µm; diagnostic blue‑green droplets in EO preparations (chamazulene).

CAS numbers:
84082‑60‑0
Common names: German chamomile, blue chamomile, Hungarian chamomile

Geographic distribution & cultivation: Widely cultivated in Europe (Hungary, Germany, Poland), Egypt, Argentina, and parts of Asia. 
Prefers well‑drained loamy soils, pH 6–7.5; temperate climate; flowering harvested at full bloom.
Quality grades: Pharmacopoeial monographs typically specify losses on drying, total ash, swelling index, essential oil content (≥0.4–1.0% m/m depending on monograph), and limits for pesticides and PAHs.

Definitions and Grades of Oily Extracts
Oil infusion (macerate): Dried capitula macerated in fixed oil (e.g., Helianthus annuus seed oil, Simmondsia chinensis seed oil, caprylic/capric triglyceride) at 1:5–1:10 drug:extract ratio (DER native), 20–60 °C for 24–72 h with intermittent agitation; filtered and polished. 
May be heat‑assisted or ultrasound‑assisted.

Lipophilic solvent extract: N‑hexane or food‑grade hydrocarbons for defatting/terpene extraction; solvent removal under reduced pressure; reconstitution in cosmetic‑grade carrier oil to target potency (e.g., α‑bisabolol 0.1–0.5% w/w).

Supercritical CO₂ extract: Select (low‑wax) fraction at 90–150 bar/35–45 °C enriches sesquiterpenes (bisabolol, chamazulene precursors); total extract at 250–350 bar includes waxes. 
Often supplied pre‑diluted in MCT.

Essential oil (steam distillate) in oil: Steam‑distilled EO (blue; chamazulene) solubilized in fixed oil to form an "oily extract" for direct topical use.

Regulatory identifiers:
Oily macerates are typically labeled Chamomilla Recutita (Matricaria) Flower Extract in [carrier oil]; CAS 84082‑60‑0.
Essential oil components reference Matricaria Recutita Flower Oil; CAS 8002‑66‑2.

Chemical Composition (Lipophilic Focus)
Primary lipophilic constituents:
Sesquiterpene alcohols: (−)-α‑bisabolol (levomenol), β‑bisabolol, farnesol (minor)
Bisabolol oxides: Oxide A, B; minor C
Pro‑azulenes: Matricin → chamazulene upon thermal conversion during distillation (gives blue color); chamazulene can also arise from thermal or acidic conversion during CO₂ processing
Spiroethers (dicycloethers): cis‑ and trans‑en‑yne dicycloethers (antispasmodic contribution)
Flavonoid aglycones: Apigenin, luteolin, quercetin (more prominent in hydroalcoholic extracts but detectable in CO₂ totals and macerates bound to lipids)
Coumarins: Umbelliferone, herniarin (lipophilic fraction)
Phytosterols and triterpenes: β‑sitosterol, stigmasterol, taraxasterol
Waxes: Long‑chain esters, fatty alcohols (esp. in total CO₂)
Representative ranges (typical; supplier‑dependent):
α‑Bisabolol + oxides: 10–60% in EO/CO₂ select; 0.05–1.0% in macerates
Chamazulene: 1–15% in EO (post‑distillation); trace–1% in CO₂ select; trace in macerates unless EO is added
Spiroethers: 0.5–5% (chemotype dependent)
Allergens (IFRA/UE Annex III reporting): Naturally occurring constituents such as limonene, linalool, farnesol present at trace–low %; declaration per finished product thresholds.

Physicochemical Properties
Appearance: Clear to deep blue‑green liquid for EO‑based; pale yellow to yellow liquid for macerates/CO₂ dilutions
Odor: Sweet, herbaceous, hay‑like; EO shows warm fruity notes; blue nuance from chamazulene
Relative density (20 °C): 0.88–0.96 (EO); carrier‑oil dependent for macerates
Refractive index (20 °C): 1.460–1.505 (EO)
Solubility: Practically insoluble in water; miscible with fixed oils and nonpolar solvents; soluble in ethanol ≥95% with separation at high dilution; forms clear solutions in IPM, MCT
Acid value / Peroxide value: Conform to carrier specifications (macerates) — low peroxide value required for oxidative stability

Color stability: Chamazulene susceptible to photo‑oxidation → color fades to green/brown; protect from light and oxygen

Manufacturing Processes
Raw Material Handling
Drug identity: Authenticate M. recutita via macroscopic/microscopic keys; confirm absence of Chamaemelum nobile contamination; DNA barcoding optional.
Pre‑processing: Drying ≤40 °C to preserve pro‑azulenes; milling to 1–3 mm cut to improve mass transfer; moisture 8–12%.

Extraction Unit Operations (Oily Macerate)
Charge & pre‑wet: Ratio 1:5–1:10 (w/v) plant:carrier oil in stainless vessel; inert gas blanket (N₂)
Thermal/ultrasound assistance: 40–60 °C, 2–6 h (or ambient 48–72 h) with intermittent agitation; ultrasound 20–40 kHz reduces time
Filtration & polishing: Coarse filter → 1–5 µm depth filter; optional centrifugal clarification
Standardization: Adjust to marker(s): e.g., α‑bisabolol 0.1% w/w, total phenolics 0.02–0.05% (as gallic acid equivalents) using standardized concentrates or EO spiking if permitted
Antioxidants: Add 0.05–0.1% mixed tocopherols or rosemary extract to improve stability

CO₂ Extraction (Select/Total)
Select: 100–150 bar, 35–45 °C; co‑solvent absent → high sesquiterpene selectivity
Total: 280–320 bar, 40–55 °C; co‑extracts waxes; often diluted in MCT for pourability

Steam Distillation (EO)
Charge: Fresh/dried capitula → hydrodistillation 2–4 h
Conversion: Matricin → chamazulene (thermal); copper condensers avoided to limit color variation
Fractionation: Remove aqueous phase; dry over anhydrous Na₂SO₄; store under N₂ at 4–15 °C
GMP/ISO: Cosmetic ISO 22716; food/flavor ISO 22000/HACCP as applicable.

Analytical Characterization & Quality Control
Identification
GC–MS (EO/CO₂): Fingerprint of α‑bisabolol, bisabolol oxides, chamazulene, spiroethers; RI indices vs n‑alkanes
HPLC‑DAD (macerates): Flavones (apigenin, luteolin); coumarins (herniarin); quantify as ppm–0.1%
Spectrophotometry: Chamazulene λmax ≈ 600–620 nm (qualitative colorimetric control for EO)
IR: Bands for sesquiterpene alcohols (~3400 cm⁻¹), C=C stretches (~1640–1680 cm⁻¹)

Assay markers (examples)
α‑Bisabolol: ≥0.5–1.5% (for standardized oily macerate) or ≥10–40% (EO/CO₂ select)
Total azulenes as chamazulene: 1–8% (EO), NMT 1% (oily extracts unless spiked)

Purity/contaminants
Pesticides: Meet cosmetic/pharmacopeial MRLs; GC‑MS/MS screening panels
PAHs: Particularly for CO₂ totals; BaP < 0.5 µg/kg; PAH4 < 10 µg/kg (typical targets)
Heavy metals: Pb < 10 ppm, As < 2 ppm, Cd < 1 ppm, Hg < 1 ppm (cosmetic guideline)
Residual solvents: If used (e.g., hexane), comply with ICH Q3C Class 2 limits; EO/CO₂ generally solvent‑free
Peroxide value (macerate): As per carrier oil; monitor rancidity

Microbiological
TAMC < 10³ CFU/g; TYMC < 10² CFU/g; absence of S. aureus, P. aeruginosa in 1 g (for cosmetic grade oily extracts)

SAFETY INFORMATION ABOUT MATRICARIA OILY EXTRACT

 
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