Calcium Carbonate and Modified Starch Pharmaceutical Excipient Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Calcium Carbonate and Modified Starch 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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Calcium Carbonate and Modified Starch 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 Calcium Carbonate and Modified Starch Pharmaceutical Excipient.

Calcium Carbonate and Modified Starch compositions is useful as pharmaceutical excipients as direct compression. The combination formula is better suited than the individual excipients, Modified Starch, and Calcium carbonate. Improved disintegration properties were obtained by blending Modified Starch with an insoluble vehicle such as calcium carbonate.

Typical Composition and Specifications of Modified Starch Coated Calcium Carbonate:
Description: White odorless powder.
Solubility: Water Dispersible.
Assay(Calcium Carbonate): NLT 80.0% to NMT 84%.
Moisture Content by KF: NMT 7.0
pH(1% Aqueous Solution): NLT 7.00 to NMT 10.00.
Total Viable Count: NMT 1000 cfu/g.
Total Yeasts and Molds: NMT 100 cfu/g.
Total Enterobacteria: NMT 10 cfu/g.
Aerobic spore forming Bacteria: NMT 1000 cfu/g.
Salmonella: Absent/25g.
E.coli: Absent/g.
S. aureus: Absent/g.

MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
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Call toll-free 1-877-682-9243 (1-877-MUBYCHEM)

Exporters to USA Canada UAE Europe South Africa Tanzania Kenya Uganda Egypt Nigeria Turkey Mexico Brazil Argentina Chile Dubai etc.

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Modified Starch Coated Calcium Carbonate SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 29-Sept-22

Product Name & Other Names: Modified Starch Coated Calcium Carbonate.
Relevant uses and uses advised against (if any): Laboratory Chemicals and Industrial Manufacturing Use.
Supplier: As per letterhead.

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 causes mild skin irritation.
May causes mild eye 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.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
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.
P337+313: If eye irritation persists get medical advice/attention.

Ingredient I: Calcium Carbonate
CAS No.: 471-34-1
EINECS EC Number: 207-439-9
Percent: >80%
Ingredient I: Modified Starch
CAS No.: 9005-84-9 or 9045-28-7 or 68412-29-3 or 9005-25-8 etc.
EINECS EC Number: NA
Percent: <20%

First Aid: CALL A PHYSICIAN.
Skin: Wash exposed area with soap and water.
Eyes: Wash eyes with plenty of water for at least 15 minutes, lifting lids occasionally. Seek Medical Aid.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
Ingestion: If swallowed, induce vomiting immediately after giving two glasses of water. Never give anything by mouth to an unconscious person.

Fire: Not considered to be a fire hazard.
Explosion: Not considered to be an explosion hazard.
Fire Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Use means suitable for extinguishing surrounding 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.

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, 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. 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 like strong oxidizing agents, acids, fluorine, magnesium with hydrogen.

Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume, or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit.
Exposure Limits for Calcium Carbonate:
TWA: 15 (mg/m3) from OSHA (PEL) [United States] Inhalation Total.
TWA: 5 (mg/m3) from OSHA (PEL) [United States] Inhalation Respirable.
TWA: 10 (mg/m3) from ACGIH (TLV) [United States]
TWA: 10 (mg/m3) [United Kingdom (UK)] Inhalation Total.
TWA: 4 (mg/m3) [United Kingdom (UK)] Inhalation Respirable.3
Consult local authorities for acceptable exposure limits.
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. 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: Fine, white granules and powder.
Odor: Odorless.
Odor threshold: Not available.
pH: NLT 7.00 to NMT 10.00.
Relative density: around 2.7 - 2.95
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: Not available.
Viscosity: Not available.

Stability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: When heated to decomposition emits calcium oxide, liberates carbon dioxide and fumes.
Hazardous Polymerization: Will not occur.
Incompatibilities: Direct sunlight, heat, accumulation of airborne dusts, oxidizing agents, acids, fluorine, magnesium with hydrogen.
Conditions to Avoid: Heat, incompatibles.

Acute toxicity: LD50 Oral - Rat - 6,450 mg/kg (Calcium carbonate).
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as possible or confirmed human carcinogen by IARC, ACGIH, OSHA and NTP.
Teratogenic Effects: Not available.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

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.

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 of and unused contents in accordance with federal, state, and local requirements.

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

USA Regulations:
SARA 311/312: No SARA hazards.
California Proposition 65: This product does not contain any California Proposition 65 listed chemicals.

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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