Diclofenac Sodium BP Ph Eur EP IP JP USP Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Diclofenac Sodium BP Ph Eur EP IP JP USP 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.

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Diclofenac Sodium CAS Number 15307-79-6, EINECS EC Number: 239-346-4, Molecular Formula: C14H10Cl2NNaO2, Molecular Weight: 318.13, HS Code ---**

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

Diclofenac Sodium BP Ph Eur Grade Specifications:
C14H10Cl2NNaO2 --- 318.1 CAS 15307-79-6
Action and use: Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.

DEFINITION
Sodium [2-[(2,6-dichlorophenyl)amino]phenyl]acetate.
Content: 99.0 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or slightly yellowish, slightly hygroscopic, crystalline powder.
Solubility: Sparingly soluble in water, freely soluble in methanol, soluble in ethanol (96 per cent), slightly soluble in acetone.
Melting Point: About 280C, with decomposition.

IDENTIFICATION
First identification: A, D.
Second identification: B, C, D
A. Infrared absorption spectrophotometry.
B. Thin-layer chromatography.
C. Dissolve about 10 mg in 10 mL of ethanol (96 per cent). To 1 mL of this solution add 0.2 mL of a mixture, prepared immediately before use, of equal volumes of a 6 g/L solution of potassium ferricyanide and a 9 g/L solution of ferric chloride. Allow to stand protected from light for 5 min. Add 3 mL of a 10 g/L solution of hydrochloric acid. Allow it to stand, protected from light, for 15 min. A blue colour develops and a precipitate is formed.
D. Dissolve 60 mg in 0.5 mL of methanol and add 0.5 mL of water. The solution gives reaction of sodium.

TESTS
Appearance of solution: The solution is clear and its absorbance at 440 nm is not greater than 0.05.
Dissolve 1.25 g in methanol and dilute to 25.0 mL with the same solvent.
Related substances: To pass the test by liquid chromatography.
Storage: In an airtight container, protected from light.

Diclofenac Sodium USP Grade Specifications:
C14H10Cl2NNaO2 --- 318.13
Benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino]-, monosodium salt;
Sodium [o-(2,6-dichloroanilino)phenyl]acetate CAS 15307-79-6
UNII: QTG126297Q
UNII: 144O8QL0L1

DEFINITION
Diclofenac Sodium contains NLT 99.0% and NMT 101.0% of diclofenac sodium (C14H10Cl2NNaO2), calculated on the dried basis.

IDENTIFICATION
A. Infrared Absorption.
B. The retention time of the diclofenac peak of the Sample solution corresponds to that of the System suitability solution, as obtained in the test for Organic Impurities.
C. The residue obtained by igniting it imparts an intense yellow color to a nonluminous flame.

Organic Impurities: To pass the test by chromatography.
Color of Solution: A solution (1 of 20) of Diclofenac Sodium in methanol is colorless to faintly yellow, and the absorbance of the solution, determined in a 1-cm cell at 440 nm, is NMT 0.050, methanol being used as the blank.
Clarity of Solution: The solution prepared as directed under Color of Solution is not significantly less clear than an equal volume of methanol contained in a similar vessel and examined similarly.
pH: A solution (1 of 100) has pH 7.0–8.5
Loss on Drying: Dry at 105C - 110C for 3 h. NMT 0.5%
Packaging and Storage: Preserve in tight, light-resistant containers.

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.

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Diclofenac Sodium SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 08-Sept-24

Product Name & Other Names: Diclofenac Sodium.
CAS No.: 15307-79-6
EINECS EC Number: 239-346-4
Molecular Weight: 318.13
Chemical Formula: C14H10Cl2NNaO2
Relevant uses and uses advised against (if any): Industrial use.
Suppliers: As per letterhead.

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

Acute toxicity, Oral: Category 3, H301
Reproductive toxicity (Category 2), H361
Specific target organ toxicity - repeated exposure, Oral (Category 1), Peripheral nervous system, H372

Hazard Statements:
H301: Toxic if swallowed.
H361: Suspected of damaging unborn child.
H372: Causes damage to organs through prolonged or repeated exposure.

Precautionary Statements:
P201 - Obtain special instructions before use.
P301+P310: IF SWALLOWED: Immediately call a POSION CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash contaminated parts 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.
P302+352: IF ON SKIN: Wash with plenty of soap and water.
P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes.
P337+P313: If eye irritation persists get medical advice/attention.
P403+P404: Store in well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P501: Dispose of contents/container in accordance with local/national regulation.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
T Toxic.
Xn Harmful.
Risk Phrases:
R25 Toxic if swallowed.
R48 Danger of serious damage to health by prolonged exposure.
R61 May cause harm to the unborn child.

Product Name & Other Names: Diclofenac Sodium.
CAS No.: 15307-79-6
EINECS EC Number: 239-346-4

Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: Induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an unconscious person. Get medical attention.
Skin Contact: Immediately flush skin with plenty of water for at least 15 minutes. Remove contaminated clothing and shoes. Get medical attention. Wash clothing before reuse. Thoroughly clean shoes before reuse.
Eye Contact: Check for and remove any contact lenses. Immediately flush your eyes with running water for at least 15 minutes, keeping eyelids open. Cold water may be used. Do not use eye ointment. Seek medical attention.

Fire: Not expected to be a fire hazard. However, it may burn at high temperature.
Fire Extinguishing Media: Water spray, dry chemical, alcohol foam, or carbon dioxide.
Special hazards arising from the substance or mixture: Carbon oxides Nitrogen oxides (NOx), Chlorine compounds and Fumes. Avoid solid water jets as they can scatter the fire. Combustible.
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. 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:
Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container.
Large Spill: Do not inhale dust, vapors, 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 allow to evacuate as per law.

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. 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 oxidizing agents. Storage: 15C to 30C. Ok to freeze. Short term shipping may be ambient.

Airborne Exposure Limits: This product, as supplied, 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 as low as possible. Local exhaust ventilation is 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): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator (NIOSH type N95 or better filters) may be worn. If oil particles (e.g., lubricants, cutting fluids, glycerin, etc.) are present, use a NIOSH type R or P filter. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator. WARNING: Air-purifying respirators do not protect workers in oxygen-deficient atmospheres.
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. Wash hands after handling.

Appearance: White crystalline powder. Hygroscopic.
Odor: Not available.
Odor threshold: Not available.
pH: 7 to 8.5
Relative density: Not available.
Melting Point: 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: Soluble in methanol, giving clear solution.
Viscosity: Not available.
Molecular Weight: 318.13
Chemical Formula: C14H10Cl2NNaO2

Stability: Stable under ordinary conditions of use and storage. Forms explosive mixtures with air on intense heating.
Hazardous Decomposition Products: May emit ammonia, nitrogen oxides, carbon oxides, chlorine compounds and fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Incompatibilities: Oxidizing agents.
Conditions to Avoid: Incompatibles. Moisture.

Oral rat LD50: 53 mg/kg.
Orl Mouse LD50: 95 mg/kg.
Carcinogenicity: No information available.
Teratogenic Effects: Not available.
Mutagenic Effects: Mutagenic.
Developmental Toxicity: Not available.
Reproductive Effects: Suspected of damaging the unborn child.

Toxicity to fish: No information available.
Persistence and Degradability: Unlikely to persist due.
Mobility: Likely to be mobile.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.

Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Processing use or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with law.

DOT USA, TDG Canada & ADR/RID Europe:
Proper Shipping Name: Toxic solid, organic, n.o.s. (Diclofenac Sodium).
Hazard Class: 6.1
UN/NA: UN 2811
Packing Group: III.
IMDG/IMO:
Proper Shipping Name: Toxic solid, organic, n.o.s. (Diclofenac Sodium).
Hazard Class: 6.1
UN/NA: UN 2811
Packing Group: III.
IATA/ICAO:
Proper Shipping Name: Toxic solid, organic, n.o.s. (Diclofenac Sodium).
Hazard Class: 6.1
UN/NA: UN 2811
Packing Group: III.

European Labeling in Accordance with EC Directives:
H301: Toxic if swallowed.
H361: Suspected of damaging unborn child.
H372: Causes damage to organs through prolonged or repeated exposure.

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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