OXYTOCIN

Oxytocin / Ocytocin / Alpha-Hypophamine / Syntocinon / Pitocin
CAS Number: 50-56-6
EC Number: 200-048-4

SECTION 1: PRODUCT IDENTIFICATION AND CHEMICAL IDENTITY

Parameter	Information
Product Name	Oxytocin
Chemical Name (IUPAC)	(Cys-Tyr-Ile-Gln-Asn-Cys-Pro-Leu-Gly-NH₂)
Other Names	Ocytocin, Alpha-Hypophamine, Syntocinon, Pitocin
CAS Number	50-56-6
EC Number (EINECS)	200-048-4
Molecular Formula	C₄₃H₆₆N₁₂O₁₂S₂
Molecular Weight	1007.19 g/mol
Chemical Class	Peptide hormone (neurohypophysial hormone)
Appearance	White to off-white amorphous powder (lyophilized) or clear solution
Odor	Odorless
Physical State (20°C)	Solid (lyophilized powder) or liquid (injectable solution)

Oxytocin is a peptide hormone synthesized in the hypothalamus and secreted from the posterior pituitary gland. It consists of nine amino acids and plays a critical role in obstetric applications such as labor induction, postpartum hemorrhage control, and lactation support. It also influences neurobehavioral processes including social bonding, trust, and empathy. In medical practice, it should only be used under controlled conditions and specialist physician supervision.

SECTION 2: SYNONYMS AND OTHER NAMES

Type	Name
Turkish Names	Oksitosin, Oksitocin, Doğum Hormonu
English Names	Oxytocin, Ocytocin, Alpha-Hypophamine, Pitocin, Syntocinon
Chemical Names	(Cys-Tyr-Ile-Gln-Asn-Cys-Pro-Leu-Gly-NH₂)
CAS Number	50-56-6
EC Number	200-048-4
ATC Code	H01BB02
HS Code	2937.19

SECTION 3: CHEMICAL STRUCTURE

3.1. Amino Acid Sequence

Oxytocin is a peptide consisting of 9 amino acids. A disulfide bridge is formed between cysteine residues at positions 1 and 6.

Amino Acid Sequence:

Cys(1) - Tyr(2) - Ile(3) - Gln(4) - Asn(5) - Cys(6) - Pro(7) - Leu(8) - Gly(9) - NH₂
                         |___________________|
                            Disulfide Bridge
                         (Between Cys1 and Cys6)

Single-Letter Code:
CYIQNCPLG-NH₂

3.2. Molecular Formula

C₄₃H₆₆N₁₂O₁₂S₂

3.3. Molecular Weight

1007.19 g/mol

3.4. Key Structural Features

Feature	Description
Number of Amino Acids	9
Disulfide Bridge	Between Cys1 and Cys6
C-Terminus	Amidated (-NH₂)
N-Terminus	Free amino group
Secondary Structure	Cyclic (stabilized by disulfide bridge)
Isoelectric Point (pI)	~7.7

SECTION 4: PHYSICAL AND CHEMICAL PROPERTIES

Property	Value
Appearance	White to off-white amorphous powder (lyophilized) or clear solution
Odor	Odorless
Molecular Formula	C₄₃H₆₆N₁₂O₁₂S₂
Molecular Weight	1007.19 g/mol
Melting Point	~140 °C (decomposes)
Water Solubility	High solubility (soluble)
Ethanol Solubility	Low solubility
pH (aqueous solution)	3.0 – 5.0 (stabilized with acidic buffer)
LogP	~-1.5 (hydrophilic)
Stability	Stable when stored cold and protected from light
Hygroscopicity	Hygroscopic
Optical Rotation ([α]D²⁰)	-25° to -35° (c=0.5, water)

SECTION 5: SOLUBILITY PROFILE

Solvent	Solubility	Conditions
Water	High solubility	20°C
Ethanol	Low solubility	25°C
Methanol	Slightly soluble	25°C
Acetone	Insoluble	25°C
Chloroform	Insoluble	25°C
Ether	Insoluble	25°C

SECTION 6: CHEMICAL PROPERTIES AND REACTIVITY

Property	Information
Chemical Character	Amphoteric (peptide)
Disulfide Bridge	Can be cleaved by reducing agents (DTT, β-mercaptoethanol)
Stability	Stable under normal storage conditions
Heat Sensitivity	Decomposes at high temperatures
Light Sensitivity	Sensitive to light
Enzymatic Degradation	Degraded by proteases and peptidases
Incompatible Materials	Strong oxidizers, reducing agents, heat, light

SECTION 7: PHARMACOLOGICAL PROPERTIES

7.1. Mechanism of Action

Parameter	Description
Receptor	Oxytocin receptor (G-protein coupled receptor)
Signaling Pathway	Phospholipase C (PLC) activation; IP₃ and DAG pathway
Second Messenger	Intracellular calcium (Ca²⁺) increase
Uterine Effect	Contraction of uterine smooth muscle
Mammary Effect	Contraction of myoepithelial cells; milk ejection
Social Effects	Modulation of neuronal activity; bonding, trust, empathy

7.2. Pharmacokinetics

Parameter	Information
Half-Life (Intravenous)	~3 – 10 minutes
Half-Life (Intranasal)	~15 – 30 minutes
Metabolism	Rapidly degraded by oxytocinase and other proteases
Excretion	Renal excretion (as metabolites)
Elimination Half-Life	~4 – 6 minutes

SECTION 8: APPLICATIONS AND INDUSTRIAL USES

8.1. Obstetric Applications

Application	Description
Labor Induction	Used as intravenous infusion to initiate and augment uterine contractions.
Postpartum Hemorrhage	Used to prevent uterine atony and control bleeding.
Post-Cesarean Section	Used to support uterine involution.
Post-Miscarriage	Used to control bleeding.

8.2. Lactation Support

Application	Description
Milk Ejection	Stimulates the milk ejection reflex (let-down) in mammary glands.
Breastfeeding Difficulties	Intranasal spray form may be used to facilitate milk let-down.

8.3. Research and Experimental Applications

Application	Description
Neuroendocrine Studies	Research on the hypothalamus-pituitary-gonadal axis.
Social Behavior Research	Studies on bonding, trust, empathy, love, maternal behavior.
Psychiatric Research	Experimental use in autism, social anxiety, schizophrenia.
Neuroimaging	Functional MRI studies on brain activity.

8.4. Veterinary Applications

Application	Description
Labor Induction	Labor induction in animals.
Milk Let-Down	Supports milk let-down in animals.
Uterine Bleeding	Controls postpartum uterine bleeding.

SECTION 9: DOSAGE AND ADMINISTRATION

Application	Route	Typical Dose	Description
Labor Induction	Intravenous (IV) infusion	1-4 mU/min, titrated upward	Increased by titration; maximum 40 mU/min
Postpartum Hemorrhage	Intravenous (IV) or Intramuscular (IM)	5-10 IU	Rapid effect in uterine atony
Lactation Support	Intranasal (IN)	1-2 IU (per nostril)	Administered before breastfeeding
Cesarean Section	Intravenous (IV) bolus	2-5 IU	Slow IV injection

SECTION 10: SIDE EFFECTS

Effect	Frequency	Description
Uterine Hyperactivity	Common	Excessive and frequent contractions; may cause fetal distress.
Hypotension	Common	Transient drop in blood pressure; especially with rapid IV injection.
Tachycardia	Common	Increase in heart rate.
Nausea and Vomiting	Common	Especially at high doses.
Water Retention	Rare	Due to antidiuretic effect; risk of hyponatremia.
Allergic Reactions	Rare	Skin rash, anaphylaxis (rare).
Headache	Rare	Vasodilatory effect.

SECTION 11: CONTRAINDICATIONS

Condition	Description
Significant CPD (Cephalopelvic Disproportion)	Baby's head is too large to pass through the pelvis.
Malpresentation (Abnormal Position)	Abnormal fetal position (transverse, breech).
Fetal Distress	Abnormal fetal heart rate.
Excessive Uterine Activity	Already hypertonic uterine contractions.
Placenta Previa	Placenta overlying the cervix.
Previous Cesarean Section	Risk of uterine scar rupture.
Hyperstimulation	Overdose or prolonged use.

SECTION 12: SAFETY AND TOXICOLOGY

Parameter	Value
Acute Oral Toxicity (LD50, Rat)	> 50,000 IU/kg
Acute Intravenous Toxicity (LD50, Rat)	~10 – 20 IU/kg
Skin Irritation	Mild irritant
Eye Irritation	Mild irritant
Mutagenicity	Negative
Carcinogenicity	Not classified
Teratogenicity	No teratogenic effects shown in animal studies
Lactation	Excreted in milk; no known adverse effects on infant
Pregnancy Category	FDA Category A (no risk shown in controlled studies)

SECTION 13: GHS CLASSIFICATION

Hazard Class	Category	H-Statement
Reproductive Toxicity	Category 2	H361
Skin Irritation	Category 2	H315
Eye Irritation	Category 2	H319

Signal Word: WARNING

Hazard Pictograms: GHS07 (Exclamation Mark), GHS08 (Health)

Hazard Statements (H-Codes):

Code	Statement
H315	Causes skin irritation.
H319	Causes serious eye irritation.
H361	Suspected of damaging fertility or the unborn child.

SECTION 14: PRECAUTIONARY STATEMENTS (P-CODES)

Code	Statement
P201	Obtain special instructions before use.
P202	Do not handle until all safety precautions have been read and understood.
P261	Avoid breathing dust/fume/gas/mist/vapors/spray.
P280	Wear protective gloves/protective clothing/eye protection/face protection.
P302+P352	IF ON SKIN: Wash with plenty of soap and water.
P305+P351+P338	IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present.
P308+P313	IF exposed or concerned: Get medical advice/attention.
P501	Dispose of contents/container in accordance with local regulations.

SECTION 15: FIRST AID MEASURES

Route of Exposure	Action to Be Taken
Inhalation	Move to fresh air. If breathing difficulty occurs, seek medical attention.
Skin Contact	Wash with plenty of soap and water. Remove contaminated clothing. If irritation persists, consult a physician.
Eye Contact	Rinse thoroughly with plenty of water for at least 15 minutes. Remove contact lenses. Seek medical attention.
Ingestion	Rinse mouth with water. Do not induce vomiting. Seek immediate medical attention.
Injection Site Reaction	Local cold application. If symptoms persist, seek medical attention.

SECTION 16: FIRE-FIGHTING MEASURES

Parameter	Information
Fire Hazard	Not flammable; may decompose at high temperatures.
Hazards During Fire	Thermal decomposition produces toxic fumes including carbon monoxide, carbon dioxide, and nitrogen oxides (NOₓ).
Suitable Extinguishing Media	Water spray, CO₂, dry chemical powder, alcohol-resistant foam.
Special Protective Equipment	Self-contained breathing apparatus (SCBA), full protective clothing.

SECTION 17: ACCIDENTAL RELEASE MEASURES

Parameter	Information
Personal Protection	Protective gloves, goggles, appropriate laboratory coat.
Ventilation	Increase ventilation; use local exhaust in confined spaces.
Containment	Cover spilled area to prevent dust dispersion.
Cleaning Methods	Collect dry using vacuum or careful sweeping. For solution form, collect with absorbent material.
Environmental Precautions	Prevent entry into drains, sewers, and water bodies.
Waste Disposal	Dispose of as medical waste in accordance with local regulations.

SECTION 18: STORAGE AND SHELF LIFE

Parameter	Information
Storage Conditions	2 – 8 °C (cold chain), protect from light and moisture.
Container Requirements	Tightly closed, light-resistant, original packaging.
Materials to Avoid	Light, heat, moisture, oxidizers, reducing agents.
Shelf Life (Lyophilized)	24-36 months (under proper storage conditions, cold chain).
Shelf Life (Solution)	12-24 months (under proper storage conditions, cold chain).
Solution Preparation	Should be reconstituted immediately before use. Reconstituted solution is stable for 24 hours under refrigeration.
Stability Note	Sensitive to heat and light; avoid cold chain interruption.

SECTION 19: PACKAGING OPTIONS

Packaging Type	Quantity	Material
Glass Vial (Lyophilized Powder)	1 – 10 mg	Type I glass, rubber stopper + aluminum seal
Glass Ampoule (Solution)	1 – 10 IU/mL	Type I glass
Glass Vial (Solution)	1 – 10 mL	Type I glass, rubber stopper + aluminum seal
Intranasal Spray Bottle	10 – 20 mL	HDPE / Glass
Bulk Powder	1 – 10 g	Aluminum foil bag (inert atmosphere)

SECTION 20: TRANSPORT INFORMATION

Parameter	Information
UN Number	Not applicable (not classified as dangerous goods)
Hazard Class	Not applicable
Packing Group	Not applicable
ADR/RID	Not regulated
IMDG Code	Not regulated
IATA (Air)	Not regulated
Marine Pollutant	No
Transport Conditions	Cold chain (2-8°C) ; protect from light and moisture.

SECTION 21: REGULATORY INFORMATION

Region / Authority	Status
European Union	Approved as a medicinal product (ATC: H01BB02).
USA (FDA)	Approved as a medicinal product (Pitocin, Syntocinon).
Turkey	Approved as a medicinal product; regulated by Turkish Medicines and Medical Devices Agency.
WHO (World Health Organization)	Included in the WHO Essential Medicines List.
Prescription Status	Prescription-only medicinal product (hospital use only).

SECTION 22: RELATED COMPOUNDS AND DERIVATIVES

Compound	Description
Vasopressin (Antidiuretic Hormone / ADH)	Structurally related neurohypophysial hormone.
Atosiban	Oxytocin antagonist; used in preterm labor (to stop premature labor).
Carbetocin	Oxytocin analogue; longer-acting, used to prevent postpartum hemorrhage.
Demoxytocin	Oxytocin analogue; used in veterinary medicine.

SECTION 23: QUICK REFERENCE TABLE

Property	Value
CAS Number	50-56-6
EC Number	200-048-4
Molecular Formula	C₄₃H₆₆N₁₂O₁₂S₂
Molecular Weight	1007.19 g/mol
Appearance	White to off-white amorphous powder
Melting Point	~140 °C (decomposes)
Water Solubility	High solubility
Half-Life (IV)	~3 – 10 minutes
Primary Use	Labor induction, postpartum hemorrhage
Storage	2 – 8 °C (cold chain)
Shelf Life	24-36 months
UN Number	Not applicable

SECTION 24: CRITICAL NOTICES AND BEST PRACTICES

CRITICAL NOTICES:

Cold Chain Requirement: Oxytocin must be stored at 2-8°C under cold chain conditions. Cold chain interruption causes product degradation and loss of efficacy.
Prescription-Only Medicinal Product: Oxytocin should only be used by prescription and under specialist physician supervision in a hospital setting.
Contraindications: Contraindicated in cases of significant CPD, malpresentation, fetal distress, placenta previa, and previous cesarean section.
Uterine Hyperactivity: Overdose or rapid infusion may cause uterine hyperactivity and fetal distress. Administer with careful dose titration.
Water Retention: Due to antidiuretic effect, there is a risk of water retention and hyponatremia, especially when given with large volumes of IV fluids.
Hypotension: Rapid IV injection may cause transient hypotension; slow IV infusion or IM administration is preferred.
Pregnancy Category: Although FDA Category A, should only be used when medically indicated.
Research Use: Intranasal oxytocin use in social behavior research is experimental and requires ethics committee approval.

BEST PRACTICE RECOMMENDATIONS:

Storage: Store under cold chain (2-8°C) conditions, protected from light, in original packaging. Do not freeze.
Personnel Protection: Use protective gloves and goggles. Avoid inhalation of powder.
Preparation: Reconstitute lyophilized product immediately before use. Use reconstituted solution within 24 hours under refrigeration.
Administration: Administer in a hospital setting, with fetal monitoring, via slow IV infusion or IM injection.
Dosage: Titrate according to patient response. Do not exceed maximum dose.
Side Effect Monitoring: Closely monitor uterine activity, fetal heart rate, blood pressure, and fluid status.
Waste Management: Dispose of unused product and waste as medical waste in accordance with local regulations.

LEGAL DISCLAIMER:

This Technical Data Sheet (TDS) is for informational purposes only and is prepared based on available technical data. The user is solely responsible for determining the suitability of the product for their specific application and for complying with all local, national, and international regulations. For complete safety, storage, handling, transport, waste, and regulatory compliance information, the official Safety Data Sheet (SDS/MSDS) and the product package insert provided by the manufacturer/supplier must be consulted. This document does not substitute professional or medical advice. Oxytocin should only be used by authorized healthcare professionals.

Oxytocin, Ocytocin, Alpha Hypophamine, Syntocinon, Pitocin, 50-56-6