Hydroxyzine Hydrochloride or Hydroxyzine HCl or Hydroxyzine Dihydrochloride USP EP BP Ph Eur Grade Manufacturers, with SDS GHS MSDS Sheet |
Supplier, Manufacturer, Exporter of Hydroxyzine Hydrochloride or Hydroxyzine HCl or Hydroxyzine Dihydrochloride USP EP BP Ph Eur Grade, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy Portugal, Bangladesh, etc. The products are offered as per required specifications and in correct shape and size in mm or meshs or microns as specified by the buyer. The participating units have one or more accreditations like FDA - cGMP and GLP approval, ISO-9001 Certified, "REACH" Registered, ISO-14001, ISO/IEC 17025, ISO-22000, FSSC 22000, ISO 45001, Kosher Certified, Halal Certified, HACCP, FSSAI. We offer Commercial Pure & IP BP EP Ph Eur USP NF JP FCC Food Grade Analytical Reagent Grades of Chemicals |
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Hydroxyzine Hydrochloride or Hydroxyzine HCl or Hydroxyzine Dihydrochloride CAS Number 2192-20-3, EINECS EC Number: 218-586-3, Molecular Formula: C21H29Cl3N2O2, Molecular Weight: 447.83, HS Code 29335990
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SDS MSDS Sheet of Hydroxyzine Hydrochloride or Hydroxyzine HCl or Hydroxyzine Dihydrochloride Manufacturers
Hydroxyzine Hydrochloride
Hydroxyzine HCl or Hydroxyzine Dihydrochloride USP EP BP Ph Eur Grade Suppliers
Hydroxyzine Hydrochloride or Hydroxyzine Dihydrochloride or Hydroxyzine HCl is a prescription antihistamine used for short-term anxiety relief, itching, chronic hives, and sedation before/after surgery.
General Properties and Specifications of Hydroxyzine Hydrochloride or Hydroxyzine Dihydrochloride or Hydroxyzine HCl:
Appearance: White to Light yellow powder to crystals. Air Sensitive, Hygroscopic.
Assay: 99.0 per cent to 101.0 per cent (dried substance).
Melting Point: about 200C with decomposition.
Solubility: Freely soluble in water and in ethanol (96 per cent), very slightly soluble in acetone.
Storage: 2C to 8C.
Hydroxyzine Hydrochloride USP Grade Specifications:
C21H27ClN2O2-2HCl --- 447.83
Ethanol, 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-, dihydrochloride, (±)-;
(±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride
CAS 2192-20-3
UNII: 76755771U3
UNII: 30S50YM8OG
DEFINITION
Hydroxyzine Hydrochloride contains NLT 98.0% and NMT 102.0% of hydroxyzine hydrochloride (C21H27ClN2O2-2HCl), calculated on the anhydrous basis.
DENTIFICATION
A. Infrared Absorption
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution.
C.
Sample solution: 2.5 mg/mL of Hydroxyzine Hydrochloride in water
Analysis: To 10 mL of the Sample solution, add 2 drops of nitric acid and 1 mL of silver nitrate TS.
Acceptance criteria: A curdy, white precipitate, insoluble in 2 N nitric acid but soluble in 6 N ammonium hydroxide, separates (presence of chloride).
Assay: 98% to 1-2%
Organic Impurities: To pass the tests by Chromatography.
Water Determination: NMT 5.0%
Packaging and Storage: Preserve in tight containers. Store at controlled room temperature. Protect from light.
Hydroxyzine Hydrochloride BP Ph Eur Grade Specifications:
C21H29Cl3N2O2 --- 447.8 CAS 2192-20-3
Action and use: Histamine H1 receptor antagonist.
Preparations: Hydroxyzine Oral Solution, Hydroxyzine Tablets.
DEFINITION
(RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]ethanol dihydrochloride.
Content: 99.0 per cent to 101.0 per cent (dried substance).
CHARACTERS
Appearance: White or almost white, hygroscopic, crystalline powder.
Solubility: Freely soluble in water and in ethanol (96 per cent), very slightly soluble in acetone.
Melting Point: About200C, with decomposition.
IDENTIFICATION
First identification: A, D
Second identification: B, C, D
A. Infrared absorption spectrophotometry
B. Thin-layer chromatography.
C. Dissolve 0.1 g in ethanol (96 per cent) and dilute to 15 mL with the same solvent. Add 15 mL of a saturated solution of picric acid in ethanol (96 per cent). Allow to stand for 15 min. A precipitate is formed. Filter. Recrystallize from ethanol (96 per cent). Initiate crystallization, if necessary, by scratching the wall of the tube with a glass rod. The crystals melt at 189C to 192C.
D. It gives reaction (a) of chlorides.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
Optical rotation: -0.10° to + 0.10°, determined on solution S.
Related substances: To pass the test by Liquid chromatography
Storage: In an airtight container, protected from light.
We also offer Hydroxyzine Hydrochloride or Hydroxyzine HCl or Hydroxyzine Dihydrochloride of EP Grade Specifications.
For Original Monographs of IP Indian Pharmacopoeia EP Ph Eur European Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.
We also manufacture and supply as under:
Hydroxyzine Hydrochloride or Hydroxyzine HCl
Manufacturers:
MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +91-22-65290100, +91-22-65290101
Current Date Time in India GMT+5:30
e-mail: info@mubychem.com
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Call toll-free 1-877-682-9243 (1-877-MUBYCHEM)
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Last 2 May, 2026
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Hydroxyzine Hydrochloride or Hydroxyzine HCl or Hydroxyzine Dihydrochloride
SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 02-May-26
Section 1: Product and Company Identification
Product Name & Other Names: Hydroxyzine Hydrochloride or Hydroxyzine HCl or Hydroxyzine Dihydrochloride.
CAS No.: 2192-20-3
EINECS, EC Number: 218-586-3
Molecular Weight: 447.83
Chemical Formula: C21H29Cl3N2O2
Relevant uses and uses advised against (if any): Laboratory chemicals, Manufacture of substances
Supplier: As per letterhead.
Section 2: Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008
Acute toxicity, Oral (Category 4), H302
Reproductive toxicity, (Category 2) H361d
Specific target organ toxicity - single exposure (Category 3), Central nervous system, H336
Labeling according to GHS & Regulation (EC) No 1272/2008
GHS Label Elements Irritant | GHS Label Elements Health Hazard |
Signal Words: Danger
Hazard statements:
H302: Harmful if swallowed.
H361d: Suspected of damaging the unborn child.
H336: May cause drowsiness or dizziness.
Precautionary statements:
P260: Do not breathe dust/fume/gas/mist/vapors/spray.
P264 Wash thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P314: Get Medical advice/attention if you feel unwell.
P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/ physician if you feel unwell.
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 and easy to do. Continue rinsing.
Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbol:
Xn Harmful
Risk Phrases:
R22 Harmful if swallowed.
R67 Vapors may cause drowsiness and dizziness.
R61 May cause harm to the unborn child.
Section 3: Composition / Information on Ingredients
Product Name & Other Names: Hydroxyzine Hydrochloride or Hydroxyzine HCl or Hydroxyzine Dihydrochloride.
CAS No.: 2192-20-3
EINECS, EC Number: 218-586-3
Section 4: First Aid Measures
Always seek medical attention after first aid measures are provided.
Eyes: Immediately flush eyes with excess water for 15 minutes, lifting lower and upper eyelids occasionally.
Skin: Immediately flush skin with excess water for 15 minutes while removing contaminated clothing.
Ingestion: Call Emergency Medical immediately. Rinse mouth with cold water. Give the victim 1-2 cups of water or milk to drink. Induce vomiting immediately.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration.
Section 5: Fire Fighting Measures
Suitable extinguishing media: Use water spray, alcohol-resistant foam, dry chemicals, or carbon dioxide. Avoid solid water jets as they can scatter fire.
Protective equipment and precautions for firefighters: Use water spray, foam, or dry chemicals to extinguish fire. Firefighters should wear full firefighting turn-out gear and respiratory protection. Cool container with water spray. Material is not sensitive to impact or static discharge.
Special hazards arising from the substance: Carbon oxides, Nitrogen oxides (NOx), Chlorine compounds.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and a suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved people should evacuate to a safe place.
Section 6: Accidental Release Measures
Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage: Do not inhale dust, vapor, mist, or gas. Avoid dust formation. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allowing it to evacuate as per law.
Section 7: Handling and Storage Green
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. Wash thoroughly after handling it. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents. Storage: At room in light-resistant containers. Storage: 2C to 8C preferred.
Section 8: Exposure Controls / Personal Protection
Exposure guidelines: Not Available.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full-face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Handle in accordance with good industrial hygiene and safety practice.
Section 9: Physical and Chemical Properties
Physical state and appearance: White to Light yellow powder to crystals. Air Sensitive, Hygroscopic.
Odor: Not available.
Odor threshold: Not available.
pH (1% soln/water): Not available.
Relative density: Not available.
Melting Point: about 200C with decomposition.
Initial boiling point and boiling range: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Freely soluble in water and in ethanol (96 per cent), very slightly soluble in acetone.
Viscosity: Not available.
Molecular Weight: 447.83
Chemical Formula: C21H29Cl3N2O2
Section 10: Stability and Reactivity
Stability: Stable under recommended conditions of use and storage.
Incompatibility: Heat, light, and strong oxidizing agents. Air Sensitive, Hygroscopic.
Hazardous Decomposition Products: Carbon oxides, Nitrogen oxides (NOx), Chlorine compounds.
Hazardous Polymerization: Has not been reported.
Section 11: Toxicology Information
LD50 Oral - Rat - 950 mg/kg.
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible, or confirmed human carcinogen by IARC.
Reproductive Effects: May impair fertility. Suspected of damaging the unborn child.
Developmental Effects: No information available.
Teratogenicity: No information available.
May cause drowsiness or dizziness.
Section 12: Ecological Information
Toxicity to fish: No information available.
Results of PBT and vPvB assessment: This substance/mixture contains no components considered to be either persistent, bioaccumulative, and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.
Section 13: Disposal Considerations
Check with all applicable local, regional, and national laws and regulations.
Section 14: Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not controlled.
IATA & IMDG/IMO: Not controlled.
Section 15: Regulatory Information
USA:
SARA 311/312 Hazard Categories: Acute Health Hazard, Chronic Health Hazard.
Section 16: Other Information
European Labeling in Accordance with EC Directives:
H302: Harmful if swallowed.
H361d: Suspected of damaging the unborn child.
H336: May cause drowsiness or dizziness.
Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbol:
Xn Harmful
Risk Phrases:
R22 Harmful if swallowed.
R67 Vapors may cause drowsiness and dizziness.
R61 May cause harm to the unborn child.
Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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