Amoxicillin Trihydrate USP BP Ph Eur Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Amoxicillin Trihydrate, 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.

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Amoxicillin Trihydrate CAS Number 61336-70-7, EINECS EC Number: 248-003-8 or 933-899-1, Molecular Formula: C16H25N3O8S-3H20, Molecular Weight: 419.45, HS Code 29411030

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Amoxicillin Trihydrate.

Amoxicillin is a penicillin antibiotic that fights bacteria. Amoxicillin is used to treat many different types of infection caused by bacteria.

General Properties and Specifications of Amoxicillin Trihydrate:
Appearance: White to light yellow crystalline powder. Hygroscopic.
Assay (HPLC): 97% minimum.
pH: 3.5 - 5.5 for 0.2% aq. solution.
Water (KF): 11.5 - 14.5%
Storage: 2C to 8C (Refrigerate). Ok to freeze.

Amoxicillin USP Grade Specifications:
C16H19N3O5S- 3H2O --- 419.45
4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 6-[[amino(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-, trihydrate [2S -[2α,5α,6β(S*)]]-;
(2S ,5R ,6R)-6-[(R)-(–)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate CAS 61336-70-7
Anhydrous 365.41 CAS 26787-78-0
UNII: 804826J2HU
UNII: 9EM05410Q9

DEFINITION
Amoxicillin contains NLT 900 µg and NMT 1050 µg of C16H19N3O5S per mg, calculated on the anhydrous basis.

Total impurities: NMT 5.0%
Crystallinity: Meets the requirements.
Dimethylaniline: Meets the requirement.
pH: 3.5–6.0 in 2 mg/mL.
Water Determination: 11.5%–14.5%
Sterility Tests: Where the label states that Amoxicillin is sterile, it meets the requirements when tested as directed in Test for Sterility of the Product to Be Examined, Direct Inoculation of the Culture Medium, except to use Fluid Thioglycollate Medium containing polysorbate 80 solution (5 mg/mL) and an amount of sterile penicillinase sufficient to inactivate the amoxicillin in each tube, to use Soybean–Casein Digest Medium containing polysorbate 80 solution (5 mg/mL) and an amount of sterile penicillinase sufficient to inactivate the amoxicillin in each tube, and to shake the tubes once daily.
Bacterial Endotoxins Test: Where the label states that Amoxicillin is sterile or Amoxicillin must be subjected to further processing during the preparation of injectable dosage forms, it contains NMT 0.25 USP Endotoxin Unit/mg of amoxicillin.

Amoxicillin Trihydrate BP Ph Eur Grade:
C16H19N3O5S,3H2O --- 419.4 CAS 61336-70-7
Action and use: Penicillin antibacterial.

DEFINITION
(2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.
Semi-synthetic product derived from a fermentation product.
Content: 95.0 per cent to 102.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white, crystalline powder.
Solubility: Slightly soluble in water, very slightly soluble in ethanol (96 per cent), practically insoluble in fatty oils. It dissolves in dilute acids and dilute solutions of alkali hydroxides.

IDENTIFICATION
First identification: A
Second identification: B, C
A. Infrared absorption spectrophotometry.
B. Thin-layer chromatography.
C. Place about 2 mg in a test-tube about 150 mm long and about 15 mm in diameter. Moisten with 0.05 mL of water and add 2 mL of sulfuric acid-formaldehyde reagent. Mix the contents of the tube by swirling; the solution is practically colourless. Place the test-tube in a water-bath for 1 min; a dark yellow colour develops.

For Original Monographs of IP Indian Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.

MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
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Amoxicillin Trihydrate SDS or Safety Data Sheet
Material Safety Data Sheet 17-Oct-23

Product Name & Other Names: Amoxicillin Trihydrate.
CAS No.: 61336-70-7
EINECS EC Number: 248-003-8 or 933-899-1
Molecular Formula: C16H25N3O8S-3H20
Molecular Weight: 419.45
Relevant uses and uses advised against (if any): Industrial use only.
Supplier: As per letterhead.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Skin sensitization, Category 1, H317
Sensitization, respiratory Category 1 - H334

Hazard statements
H317 May cause an allergic skin reaction.
H334 - May cause allergy or asthma symptoms or breathing difficulties if inhaled.

Precautionary statements Prevention
P261 -Avoid breathing dust/fumes.
P271 -Use only outdoors or in a well-ventilated area.
P285: In case of inadequate ventilation wear respiratory protection.
P280 -Wear protective gloves/protective clothing/eye protection/face protection.
Precautionary statements Response
P304+341: IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+P351+P338- IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313- If eye irritation persists: Get medical advice/attention.
P302+P352 -IF ON SKIN: Wash with plenty of water and soap.
P332+P313 -If skin irritation occurs: Get medical advice/attention.
Precautionary statements Storage
P405 Store locked up.
P403+P233 Store in a well-ventilated place. Keep container tightly closed.
Precautionary statements Disposal
P501 Dispose of contents/container in accordance with local regulations.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbol:
Xn = Harmful
Risk Phrases:
R43 = May cause sensitization by skin contact.
R42 May cause sensitization by inhalation.

Product Name & Other Names: Amoxicillin Trihydrate.
CAS No.: 61336-70-7
EINECS EC Number: 248-003-8 or 933-899-1

Eye Contact: Wash out immediately with fresh running water. Ensure complete irrigation of the eye by keeping eyelids apart and away from eye and moving the eyelids by occasionally lifting the upper and lower lids. Seek medical attention without delay; if pain persists or recurs seek medical attention. Removal of contact lenses after an eye injury should only be undertaken by skilled personnel.
Skin Contact: Immediately remove all contaminated clothing, including footwear. Flush skin and hair with running water (and soap if available). Seek medical attention in event of irritation.
Inhalation: Lay patient down. Keep warm and in rest. Prostheses such as false teeth, which may block airway, should be removed, where possible, prior to initiating first aid procedures. Apply artificial respiration if not breathing, preferably with a demand valve resuscitator, bag-valve mask device, or pocket mask as trained. Perform CPR if necessary. Transport to hospital, or doctor, without delay.
Ingestion: If swallowed do NOT induce vomiting. If vomiting occurs, lean patient forward or place on left side (head-down position, if possible) to maintain open airway and prevent aspiration. Observe the patient carefully. Never give liquid to a person showing signs of being sleepy or with reduced awareness i.e., becoming unconscious. Give water to rinse out mouth, then provide liquid slowly and as much as casualty can comfortably drink. Seek medical advice.
Indication of any medical attention and special treatment needed: Treat symptomatically.

Extinguishing media: Water spray or fog, Foam, Dry chemical powder.
Fire Fighting: Alert Fire Brigade and tell them location and nature of hazard. Wear breathing apparatus plus protective gloves. Prevent, by any means available, spillage from entering drains or water courses. Use water delivered as a fine spray to control fire and cool adjacent area. DO NOT approach containers suspected to be hot. Cool fire exposed containers with water spray from a protected location. If safe to do so, remove containers from path of fire.
Fire/Explosion Hazard: Combustible solid which burns; it is estimated that most organic dusts are combustible - according to the circumstances under which the combustion process occurs, such materials may cause fires and / or dust explosions. Avoid generating dust, particularly clouds of dust in a confined or unventilated space as dusts may form an explosive mixture with air, and any source of ignition, i.e., flame or spark, will cause fire or explosion.
Combustion products: Carbon monoxide (CO), carbon dioxide (CO2), sulfur oxides, and nitrogen compounds. May emit poisonous and corrosive fumes.
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 persons should evacuate to a safe place.

Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Ensure adequate ventilation. 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:
Minor Spills: Remove all ignition sources. Clean up all spills immediately. Avoid contact with skin and eyes. Control personal contact with the substance, by using protective equipment. Use dry clean up procedures and avoid generating dust. Place in a suitable, labeled container for waste disposal.
Major Spills: Alert Emergency Services and tell them location and nature of hazard. Control personal contact by wearing protective clothing. Recover product wherever possible. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite).
IF DRY: Use dry clean up procedures and avoid generating dust. Collect residues and place in sealed plastic bags or other containers for disposal.
IF WET: Vacuum/shovel up and place in labelled containers for disposal.
ALWAYS: Wash area with water and prevent runoff into drains.

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Avoid contact with eyes, skin, and clothing. 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. Do not leave the material container open. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Store protected from heat, sparks and ignition sources and incompatible materials like oxidizers. Storage: 2C to 8C (Refrigerate). Ok to freeze.

Airborne Exposure Limits: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures below the Airborne Exposure Limits. 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. Please refer to the ACGIH document, Industrial Ventilation, A Manual of Recommended Practices, most recent edition, for details.
Personal Respirators (NIOSH Approved): If the exposure limit is exceeded, a full-face piece respirator with dust/mist filter may be worn. For emergencies or instances where the exposure levels are not known, use a full-face piece positive-pressure, air-supplied respirator. WARNING: Air purifying respirators do not protect workers in oxygen-deficient atmospheres.
Skin Protection: Wear impervious protective clothing, including boots, gloves, lab coat, apron, or coveralls, as appropriate, to prevent skin contact.
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. Wash hands after handling.

Appearance: White to light yellow crystalline powder. Hygroscopic.
Odor: Not available.
Odor threshold: Not available.
pH: 3.5 - 5.5 for 0.2% aq. solution.
Relative density: Not available.
Melting point / freezing point (°C): Not available.
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 in water (g/L): Readily soluble in water.
Viscosity: Not available.
Molecular Formula: C16H25N3O8S-3H20
Molecular Weight: 419.45

Chemical stability: Product is considered stable under recommended condition of storage. Unstable in the presence of incompatible materials.
Hazardous polymerization: Will not occur.
Conditions to avoid- Heat sparks flame moisture and incompatibilities.
Incompatible materials- Oxidizing agents
Hazardous decomposition products- Carbon monoxide (CO), carbon dioxide (CO2), sulfur oxides, and nitrogen compounds. May emit poisonous and corrosive fumes.

Toxicity to Animals:
LD50 Oral - Rat: >2.000 mg/kg.
LD50 Dermal - Rat: >2.000 mg/kg.
Mutagenicity: Data Not Available to make classification
Carcinogenicity: Not a reported carcinogen as per IARC, ACGIH, NTP & OSHA.
Reproductivity: Data Not Available to make classification.

DO NOT discharge into sewer or waterways.
Toxicity: No information available.
Persistence and Degradability: Unlikely to persist due to water solubility.
Mobility: Likely to be mobile due to water solubility.
Bioaccumulation/ Accumulation: No information available.
Mobility in soil: No information available.
Results of PBT and vPvB assessment: No data available for assessment.

Return empty containers to supplier for reuse/ recycling if possible. Legislation addressing waste disposal requirements may differ by country, state and/ or territory. Each user must refer to laws operating in their area. In some areas, certain wastes must be tracked. Dispose according to law.
In all cases disposal to sewer may be subject to local laws and regulations and follow the same.

DOT USA, TDG Canada & ADR/RID Europe: Not Regulated.
IMDG/IMO: Not Regulated.
IATA: Not Regulated.

SARA 311/312 Hazards: Acute Health Hazard. See section 2.
California Prop. 65 Components: This product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm.

European Labeling in Accordance with EC Directives:
H317 May cause an allergic skin reaction.
H335-May cause respiratory irritation.

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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