Promethazine Hydrochloride
- CAS Number
- 58-33-3
- HSN Code
- 29343000
- Molecular Formula
- C17H20N2S·HCl
- Catalogue Number
- AL3809
- Purity
- 98%
- Molecular Weight
- 320.88 g/mol
Complies with : IP | BP | USP | EP | ACS
ISO 9001
ISO 14001
GMP
COA with every batch
Key Properties
Promethazine hydrochloride is the hydrochloride salt of promethazine. It has a role as an anticoronaviral agent, a geroprotector, a sedative, a local anaesthetic, a H1-receptor antagonist, an anti-allergic agent, an antiemetic and an antipruritic drug.
Also known as Promethazine HCl, 10-(2-(Dimethylamino)propyl)phenothiazine-1-thiol hydrochloride.
- Catalogue No.
- AL3809
- CAS Number
- 58-33-3
- Molecular Formula
- C17H20N2S·HCl
- Molecular Weight
- 320.88 g/mol
- HSN Code
- 29343000
- Grade
- Extra Pure
- Product Form
- Substance
Melting point: 446 to 450 °F (decomposes); Solubility: greater than or equal to 100 mg/mL at 72 °F.
- Appearance
- Promethazine hydrochloride is an odorless white to faint yellow crystalline powder
- Shelf Life
- 2 years
- Packaging
- Available in: 25 gm glass bottle, 100 gm glass bottle, 500 gm glass bottle
- Storage
- Store in a cool, dry place, protected from light.
1.1 — Product identifier
- Chemical Name
- Promethazine Hydrochloride
- Catalogue No.
- AL3809
- Product form
- Substance
- CAS Number
- 58-33-3
- EC Number
- 200-375-2
- Grade
- Extra Pure
- EC Index Number
- 612-007-00-6
- Chemical Formula
- C17H20N2S·HCl
- HSN Code
- 29343000
- Synonyms
- Promethazine HCl, 10-(2-(Dimethylamino)propyl)phenothiazine-1-thiol hydrochloride
1.2 — Relevant identified uses of the substance or mixture and uses advised against
- Use of the substance/mixture
- Used as an antihistamine and sedative in pharmaceutical applications.
- Uses advised against
- Not specified
1.3 — Details of the supplier of the safety data sheet
- Company identification
- Address:- 102, B wing, Savgan Heights, RTO Lane,Andheri (W), Mumbai-400 053Maharashtra, India.
1.4 — Emergency Contact Details
- Phone / e-Mail
- Phone : +91 22 26317055 Mobile : +91 9820385757 e-mail : info@alphachemika.co.in
2.1 — Classification of the substance or mixture
- Classification according to Regulation (EC) No 1272/2008
- Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1; Eye Irrit. 2; STOT SE 3; Aquatic Chronic 2
- Classification source
- ECHA C&L Inventory via PubChem CID 6014 - hazard classes notified by at least 50% of companies; pictograms and signal word derived from those statements
2.2 — Label elements
- Hazard pictograms
- Irritant, Environmental Hazard
- Signal word
- Warning
- Hazard statements
- H302: Harmful if swallowed; H315: Causes skin irritation; H317: May cause an allergic skin reaction; H319: Causes serious eye irritation; H332: Harmful if inhaled; H335: May cause respiratory irritation; H411: Toxic to aquatic life with long lasting effects
2.3 — Other hazards
- Other hazards
- May cause drowsiness; handle with care to avoid exposure.
3.1 — Substance
- Name
- Promethazine Hydrochloride
- CAS No.
- 58-33-3
4.1 — Description of first aid measures
- First-aid measures after inhalation
- Move to fresh air. If symptoms persist, seek medical attention.
- First-aid measures after skin contact
- IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water.
- First-aid measures after eye contact
- First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center.
- First-aid measures after ingestion
- Rinse mouth. Do not induce vomiting. Seek medical attention immediately.
4.2 — Most important symptoms and effects, both acute and delayed
- Symptoms relating to use
- Drowsiness, dizziness, dry mouth, blurred vision, and potential allergic reactions.
4.3 — Indication of any immediate medical attention and special treatment needed
- General information
- Treat symptomatically. Show this safety data sheet to the treating physician.
5.1 — Extinguishing media
- Suitable extinguishing media
- Water spray, carbon dioxide, dry chemical powder, foam.
- Unsuitable extinguishing media
- Not specified
5.2 — Special hazards arising from the substance or mixture
- Special procedures
- Combustible material; may emit toxic fumes when burned.
5.3 — Advice for firefighters
- Protection during firefighting
- Do not enter fire area without proper protective equipment, including respiratory protection.
6.1.1 — For non-emergency personnel
- Emergency procedures
- Contain spill and collect using appropriate protective equipment. Dispose of in accordance with local regulations.
6.3 — Methods and material for containment and cleaning up
- Methods for cleaning up
- Use appropriate personal protective equipment. Sweep up and place in a suitable container for disposal.
6.4 — Reference to other sections
- Reference
- Not specified
7.1 — Precautions for safe handling
- Precautions for safe handling
- Avoid contact with skin and eyes. Use gloves and protective eyewear when handling.
- Hygiene measures
- Wash hands and other exposed areas with mild soap and water before eating, drinking or smoking and when leaving work.
7.2 — Conditions for safe storage, including any incompatibilities
- Storage conditions
- Store in a cool, dry place, away from light and moisture.
8.2 — Exposure controls
- Hand protection
- Protective gloves (e.g. nitrile rubber)
- Eye protection
- Chemical safety goggles or safety glasses
- Skin and body protection
- Wear suitable protective clothing
- Respiratory protection
- Use in a well-ventilated area. If exposure limits are exceeded, use appropriate respiratory protection.
9.1 — Information on basic physical and chemical properties
- Physical state
- Solid
- Colour
- White
- Odour
- Odourless
- Odour threshold
- Not applicable
- pH value
- 4.0 - 6.0 (in solution)
- Relative evaporation rate (butylacetate=1)
- Not applicable
- Melting point
- 446 to 450 °F (decomposes)
- Freezing point
- Not applicable
- Boiling point
- 360 °C
- Flash point
- Not applicable
- Auto-ignition temperature
- Not applicable
- Decomposition temperature
- Not applicable
- Flammability (solid, gas)
- Not flammable under normal conditions
- Vapour pressure
- Not applicable
- Relative vapour density at 20°C
- Not applicable
- Density
- 1.1 g/cm³
- Solubility
- greater than or equal to 100 mg/mL at 72 °F
- Log Pow
- Not applicable
- Viscosity, kinematic
- Not applicable
- Viscosity, dynamic
- Not applicable
- Explosive properties
- Not explosive
- Oxidising properties
- Not oxidising
- Explosive limits
- Not applicable
10.1 — Reactivity
- Reactivity
- Stable under normal conditions; avoid exposure to light and moisture.
10.2 — Chemical stability
- Chemical stability
- Stable under recommended storage conditions.
10.3 — Possibility of hazardous reactions
- Possibility of hazardous reactions
- No dangerous reactions known under normal conditions of use.
10.4 — Conditions to avoid
- Conditions to avoid
- Avoid contact with incompatible materials and excessive heat.
10.5 — Incompatible materials
- Incompatible materials
- Strong oxidizing agents.
10.6 — Hazardous decomposition products
- Hazardous decomposition products
- Not specified
11.1 — Information on toxicological effects
- Acute toxicity
- LD50 (oral, rat) is approximately 50 mg/kg.
- Skin corrosion/irritation
- H315: Causes skin irritation
- Serious eye damage/irritation
- H319: Causes serious eye irritation
- Respiratory or skin sensitisation
- H317: May cause an allergic skin reaction
- Germ cell mutagenicity
- Not classified (based on available data)
- Carcinogenicity
- Not classified (based on available data)
- Specific target organ toxicity (single exposure)
- H335: May cause respiratory irritation
- Specific target organ toxicity (repeated exposure)
- Not classified (based on available data)
12.1 — Toxicity
- Toxicity information
- Not specified
12.2 — Persistence - degradability
- Persistence - degradability
- Not specified
12.3 — Bioaccumulative potential
- Bioaccumulative potential
- Not specified
12.4 — Mobility in soil
- Mobility in soil
- Not specified
12.6 — Other adverse effects
- Environmental precautions
- Not specified
13.1 — Waste treatment methods
- Additional Info
- Dispose of contents/container in accordance with local, regional, national and international regulations.
14.1 — UN number
- UN-No. (ADR)
- 3077
- UN-No. (IMDG)
- 3077
- UN-No. (IATA)
- 3077
- UN-No. (ADN)
- 3077
- UN-No. (RID)
- 3077
14.2 — UN proper shipping name
- Proper Shipping Name (ADR)
- Environmentally hazardous substance, solid, n.o.s.
- Proper Shipping Name (IMDG)
- Environmentally hazardous substance, solid, n.o.s.
- Proper Shipping Name (IATA)
- Environmentally hazardous substance, solid, n.o.s.
- Proper Shipping Name (ADN)
- Environmentally hazardous substance, solid, n.o.s.
- Proper Shipping Name (RID)
- Environmentally hazardous substance, solid, n.o.s.
14.3 — Transport hazard class(es)
- Transport hazard class(es)
- 9
14.4 — Packing group
- Packing group (ADR)
- III
- Packing group (IMDG)
- III
- Packing group (IATA)
- III
- Packing group (ADN)
- III
- Packing group (RID)
- III
14.5 — Environmental hazards
- Dangerous for the environment
- Not specified
- Marine pollutant
- Not specified
- Other information
- No supplementary information available
15.1 — Safety, health and environmental regulations/legislation specific for the substance or mixture
- 15.1.1 EU-Regulations
- Not specified
Promethazine hydrochloride is widely used in the pharmaceutical industry as a reference standard for quality control of antihistamine and sedative medications. It is also employed in clinical settings for the treatment of allergic reactions, as well as for its sedative effects in preoperative and postoperative care. Additionally, it is utilized in the management of nausea and vomiting associated with motion sickness and certain medical treatments. Its versatility extends to veterinary medicine, where it is used to treat similar conditions in animals.
ISO 9001
ISO 14001
GMP
COA with every batch
- Batch Number
- AL-2026-AL2485B
- Manufacturing Date
- September-2026
- Expiry Date
- September-2031
- Molecular Weight
- 320.88 g/mol
| Test | Standard | Observed |
|---|---|---|
| Assay | 98% min | 98.5% |
| Melting Point | 200-202 °C | 201 °C |
| Moisture Content | <0.5% | 0.3% |
| Residue on Ignition | <0.1% | 0.05% |
| Related Substances | None detected | None detected |
| Solubility | Freely soluble in water | Freely soluble in water at room temperature. |
The above product is expected to comply with Extra Pure grade specification.
Technical Data Sheet
| Grade | Assay/Purity | Melting/Boiling Point | Moisture/LOD | Residue on Ignition | Related Substances | Solubility |
|---|---|---|---|---|---|---|
| Extra Pure | 98% | m.p. 446 to 450 °F (decomposes) | <0.5% | <0.1% | None detected | greater than or equal to 100 mg/mL at 72 °F |
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