Microcrystalline cellulose and Calcium phosphate dibasic Pharmaceutical Excipient Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Microcrystalline cellulose and Calcium phosphate dibasic Pharmaceutical Excipient, 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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Microcrystalline cellulose and Calcium phosphate dibasic Pharmaceutical Excipient CAS Number NA

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Microcrystalline cellulose and Calcium phosphate dibasic Pharmaceutical Excipients.

Microcrystalline cellulose and Calcium phosphate compositions useful as pharmaceutical excipients as direct compression. The combination formula is better suited than the individual excipients, Microcrystalline cellulose, and Calcium phosphate. Improved disintegration properties were obtained by blending microcrystalline cellulose with an insoluble vehicle such as dibasic calcium phosphate.

Appearance: It Occurs as a White Powder
Identification
Test A:
A. Sift 20 g of sample for 5 min on an air-jet sieve equipped with a screen having 38-_m openings. If more than 5% is retained on the screen, mix 30 g of sample with 270 mL of water; otherwise, mix 45 g of sample with 255 mL of water. Mix for 5 min in a single-speed, high-speed (equal to or greater than 18,000 rpm) power blender (use a Waring Blender, Model 700G, or equivalent) that has a clover-shaped jar design. The jar and blades meet the following specifications: The jar has a 7.0-cm id at the bottom and a 9.2-cm id at the top and an overall height of 21.9 cm, and the four blades are arranged so that two of the blades are pointed up and two are pointed down. Transfer 100 mL of the dispersion into a 100-mL graduated cylinder and allow it to stand for 3 h. A white, opaque, bubble-free dispersion that does not form a supernatant liquid at the surface is obtained.
B. Add a few drops of iodine TS to 20 mL of the dispersion obtained in Identification Test A, and mix. No purple to blue or blue color appears.
Test B: Dissolve about 20 mg of the substance to be examined or the prescribed quantity in 5 mL of acetic acid R. Add 0.5 mL of potassium ferrocyanide solution R. The solution remains clear. Add about 50 mg of ammonium chloride R. A white, crystalline precipitate is formed.
Test C: Dissolve 0.1 g of Anhydrous Dibasic Calcium Phosphate the Sample in 5 mL of diluted nitric acid. Warm the solution to 70C and add 2 mL of 10% ammonium molybdate solution (freshly prepared). Acceptance criteria: A yellow precipitate of ammonium phosphomolybdate is formed.
Loss on Drying at 105for 3h: NMT 5.0%
pH(5% solution): Between 5.5 to 7.5
Heavy metal: NMT 0.001%
Assay for DCP: NLT 21.0% and NMT 29.0%

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Microcrystalline Cellulose and Dicalcium Phosphate Excipient
SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 29-Sept-22

Product Name & Other Names: Microcrystalline Cellulose and Dicalcium Phosphate.
CAS No.: Mixture.
EINECS EC Number: Mixture.
Molecular Weight: Mixture.
Chemical Formula: Mixture.
Relevant uses and uses advised against (if any): Laboratory and Industrial Manufacturing Use.
SUPPLIER: As per letterhead above.

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

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.

Hazards not otherwise classified (HNOC):
May cause mild eye irritation.
May cause mild skin irritation.

Precautionary statements:
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P304 + P340: IF INHALED: 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.

Ingredient 1: Calcium Phosphate Dibasic or Dicalcium Phosphate.
CAS No.: 7757-93-9
EINECS EC Number: 231-826-1
Percentage: 20% to 50%
Ingredient 2: Microcrystalline Cellulose Powder MCCP.
CAS Number: 9004-34-6
EINECS EC Code: 232-674-9
Percentage: Balance.

Inhalation: If Dibasic Calcium Phosphate inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: Not expected to require first aid measures. If large amounts were swallowed, give water to drink and get medical advice.
Skin Contact: Not expected to require first aid measures. Wash exposed area with soap and water. Get medical advice if irritation develops.
Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention if irritation occurs.

Fire: Not considered to be a fire hazard.
Explosion: Not considered to be an explosion hazard.
Fire Extinguishing Media: Use any means suitable for extinguishing surrounding fire.
Extinguishing Media Not recommended: Avoid using solid water jet as it may scatter the fire.
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 the 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: Ventilate area of leak or spill. 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. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements.
Large Spill: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove to an approved 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. 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. 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.

Airborne Exposure Limits: None established.
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 (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. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.

Appearance: White Free-flowing powder.
Odor: Odorless.
Odor threshold: Not available.
pH: Between 5.5 to 7.5
Relative density: Not available.
Boiling Point: Not available.
Melting Point: 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: Practically soluble in water.
Viscosity: Not available.

Stability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: No information found.
Hazardous Polymerization: Will not occur.
Incompatibilities: No incompatibility data found.
Conditions to Avoid: Excessive dust generation.

Oral rat LD50: 3986 mg/kg; Skin rabbit LD50: > 2 gm/kg for Dicalcium Phosphate.
LD50 Oral - Rat - > 5000 mg/kg for Microcrystalline Cellulose.
LD50 Dermal - Rabbit - > 2.000 mg/kg Microcrystalline Cellulose.
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, ACGIH, OSHA and NTP.
Mutagenic Effects: Not available.
Teratogenic Effects: Not available.
Developmental Toxicity: Not available.

Environmental Toxicity: Not much found.
Persistence and Degradability: No information available.
Mobility: No information available.
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 material in accordance with federal, state, and local requirements.

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

USA:
SARA 311/312: No known hazards. See section 2.
California Proposition 65: Not Listed.

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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